45 June 2008 Editor: David W

International Society for Clinical News Biostatistics

Number 45 June 2008 Editor: David W. Warne

Executive Committee 2007-08 Editorial

Officers It’s not long until 2008’s conference in Copenhagen, Denmark, and this issue contains lots of information about President: Emmanuel Lesaffre (B) the conference from Philip Hougaard and Bjarne Nielsen. Vice-President: Norbert Victor (D) Next year’s conference will take place in Prague in Secretary: Harbajan Chadha-Boreham (CH) the Czech Republic and there’s an update from Zdenek Valenta. Treasurer: Koos Zwinderman (NL) John Whitehead has prepared a list of positions which will need to be filled for 2009-10, so please do consider Members volunteering to serve on the ExCom. The deadline is the end News Editor: David W. Warne (CH) of August. As announced at last year’s AGM and in the Webmaster: Bjarne Nielsen (DK) December News, we are planning to revise the Constitution: the proposed changes were placed on the Society’s website for 2007-08: Adriano Decarli (I) consultation and review from January-February 2008 and KyungMann Kim (USA) were generally considered to be a good idea. They will be put Rumana Omar (UK) to the membership for approval later this year at the same time as the postal vote for the ExCom. Catherine Quantin (F) Thanks to the contributors to this News: Emmanuel Jenö Reiczigel (H) Lesaffre, Harbajan Chadha-Boreham, Julia Singer, KyungMann Kim, Mike Campbell and Rumana Omar, Koos Marie Reilly (S) Zwinderman, John Whitehead, Sylvain Larroque, Bjarne Martin Schumacher (D) Nielsen, Philip Hougaard, Andrew Dunning, Ewa Kawalec, Vana Sypsa (GR) Zdenek Valenta and the 6 book reviewers.

WWW and Email Addresses Correspondence Address

www: http://www.iscb.info ISCB News Editor David W. Warne Permanent Office: office@ iscb.info Home: Chemin du Petit-Bel-Air 115, CH-1226 Thônex, Switzerland. Book Review Editor: sylvain.larroque@ merckserono.net david_w_warne@ bluewin.ch National Group Representatives, Deputies Subcommittee Chairs

Czech Rep.: Zdenek Valenta [valenta@ euromise.cz] Conference Organising: Harbajan Chadha-Boreham (CH) Marek Maly [mmaly@ szu.cz] Education: Rumana Omar (UK) Poland: Ewa Kawalec [mxkawale@ cyf-kr.edu.pl] Piotr Jurkowski [jurkomal@ atr.bydgoszcz.pl] Membership: Emmanuel Lesaffre (B) Walerian Piotrowski [walekpio@ ikard.waw.pl] National Groups: Julia Singer (A) Romania: Cornelia Enachescu [cenachescu@ gmail.com] Regulatory Affairs: Jørgen Seldrup (F) Eugenia Badescu [ebadescu@ k.ro] Student Conf. Awards: KyungMann Kim (USA) Hungary: Jeno Reiczigel [reiczigel.jeno@ gmail.com] Krisztina Boda [boda@ dmi.u-szeged.hu] Index

ISCB Membership ...... 2 Czech National Group: Update ...... 29 ISCB President’s Mid-Year Update...... 3 ISCB30: Prague, Czech Republic: Update ...... 29 ISCB29 Copenhagen 2008: AGM Agenda...... 3 Book Review by Sada Nand Dwivedi (India) ...... 30 ISCB Constitution: Proposed Revisions ...... 3 Book Review by Tim Friede (UK) ...... 31 ISCB29 Copenhagen 2008: Conference Awards for Book Review by Marek Brabec (Czech Republic) ...... 31 Scientists (CAS)...... 5 Book Review by Gaj Vidmar (Slovenia)...... 32 ISCB29 Copenhagen 2008: Student Conference ISCB GENERAL INFORMATION ...... 33 Awards (SCA) ...... 5 Advertising Rates ...... 33 Book Review by Herwig Friedl (Austria) ...... 6 Society’s Aims...... 33 ISCB Education SC: Course Report ...... 7 Changes of Address or Email...... 33 ISCB Financial Update from the Treasurer ...... 8 Information on Submitting Articles ...... 33 Book Review by Andreas Ziegler (Germany) ...... 10 ISCB Office and Executive Committee: Contact Elections for the Executive Committee 2009-10: Details ...... 34 Final Warning! ...... 11 ISCB Membership and Googlegroups Emailing Lists 35 Books for Review by Sylvain Larroque ...... 12 ISCB Subcommittees: Contact Details...... 36 ISCB29: Copenhagen, Denmark: Draft Programme.. 14 ISCB Membership Information ...... 38 Formation of a New Subcommittee on Vaccines...... 27 ISCB Membership Subscription ...... 39 Polish National Group: Update ...... 27 Calendar...... 40 Book Review by Denis Enachescu (Romania)...... 28 ISCB Membership

If you joined ISCB by attending ISCB28 in Alexandroupolis, but haven’t renewed your subscription for 2008, this will be your last News. Please renew using the form at the end of this News.

end end Dec Dec Dec Dec Dec Dec Dec Nov Nov Dec Nov Nov Nov Nov May Nov May *=host of Conference 89 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 07 08 Total 261 596 715 698 725 702 685 729 818 797 837 825 756 758 620 808 448 800 413 # Countries 23 32 32 31 33 34 37 37 41 40 45 41 40 38 39 40 33 41 34 1. Poland [NatGrp] 11 11 24 24 30 21 19 26 34 37 41 41 43 40 49 53 54 57 2. UK 50 90 176* 120 144 121 128 169* 135 151 153 141 190* 140 109 133 51 117 46 3. Hungary [NatGrp] 1 21 17 18 19 25* 27 29 29 33 34 41 48 42 38* 50 43 44 43 4. Romania [NatGrp] 2 4 1 1 1 19 21 30 28 30 30 30 5. USA 18 45 40 39 41 40 79* 66 76 77 89 78 75 57 51 67 39 62 29 6. Czech. Rep. [NatGrp] 1 1 1 1 1 1 2 2 1 1 1 1 3 17 36 36 28 7. Germany 30 67 75 84 71 78 72 70 186* 90 87 77 61 57 51 73 30 48 26 8. Denmark 4 58* 38 31 30 32 26 35 38 39 36 46 41 37 37 40 25 34 24* 9. France 30 52 62 50 73 67 52 52 49 53 37 93* 31 41 30 57 12 41 18 10. Belgium 13 22 27 30 30 32 35 29 25 33 36 33 23 27 24 23 12 32 17 11. Netherlands 14* 30 38 33 36 29 31 39 35 33 38 39 33 87* 35 44 17 41 13 12. Switzerland 14 25 22 80* 33 29 24 25 23 18 23 26 22 23 23 55* 19 28 12 13. Sweden 23 51 53 54 58 64 51 45 38 44 88* 50 36 34 24 23 12 19 10 14. Canada 6 12 14 14 11 13 15 14 9 9 10 14 16 8 12 12 9 19 9 15. Italy 16 33 37 32 32 33 26 33 26 63* 29 25 15 25 15 23 6 24 6 16. Japan 2 6 7 5 7 4 10 13 20 12 11 10 10 10 17 17 8 27 5 17. Austria 4 9 11 13 11 16 13 11 15 18 15 13 16 17 15 14 9 16 5 18. Norway 13 18 25 22 12 18 10 10 11 10 16 16 12 14 12 13 8 12 5 19. Australia 6 9 11 6 9 8 11 9 10 12 8 9 14 8 6 11 6 11 5 20. Finland 2 7 7 9 9 9 7 5 10 9 18 11 7 11 10 6 4 8 5 21. India 1 1 1 1 1 1 1 1 2 1 2 2 3 2 2 2 3 3 22. Greece 1 1 1 1 1 3 1 6 1 2 2 3 2* 50* 2 23. Spain 10 12 18 12 46* 23 14 16 12 11 11 8 7 15 5 9 2 8 2 24. Slovenia 1 2 3 2 1 1 3 2 1 2 1 2 3 3 4 3 5 2 25. Slovakia 1 1 2 2 2 2 26. Iran 1 1 1 1 4 1 3 1 5 1 27. South Africa 1 4 1 3 2 2 2 2 2 3 3 3 2 3 3 1 3 1 28. Israel 1 3 4 4 4 4 3 3 4 10 13 10 7 8 3 4 1 2 1 29. New Zealand 1 1 2 1 2 2 2 3 3 3 1 2 2 1 2 1 30. Portugal 1 3 5 2 2 2 2 5 5 3 4 3 3 1 1 1 2 1 31. Malaysia 2 1 2 2 1 1 1 1 1 3 3 2 1 1 1 32. Russia 1 3 3 3 2 2 1 4 3 2 1 1 1 1 1 33. Brazil 2 1 1 34. Cuba 2 2 2 2 2 2 1 1 1 35. Turkey 1 1 1 1 2 2 3 4 36. Singapore 3 6 4 5 8 5 7 2 4 6 1 2 37. Luxembourg 1 1 38. Estonia 2 1 1 1 1 39. Sri Lanka 1 1 40. United Arab Emirates 1 1 41. South Korea 3 1 1 1 42. Chile 1 43. Thailand 1 1 1 1 2 1 1 2 2 2 3 44. Mexico 1 1 1 1 1 1 2 2 2 1 1 45. Saudi Arabia 1 1 46. Indonesia 1 1 47. Taiwan 1 1 1 1 1 1 48. Malawi 1 1 1 49. Ireland 1 2 3 4 3 4 4 2 3 2 3 1 1 50. Colombia 1 1 1 1 51. China 1 1 2 3 3 3 3 3 3 3 2 52. Croatia 1 1 1 53. Gambia 1 54. Lithuania 2 55. Argentina 1 56. Kuwait 1 1 57. Sudan 1 58. Ukraine 1 1 59. Egypt 1 60. Pakistan 1 1 1 61. Philippines 1 62. Zimbabwe 1 63. Kenya 1 1 64. Oman 1

ISCB News #45 Page 2 June 2008

ISCB President’s Mid-Year Update

From Emmanuel Lesaffre Dear Friends, Our annual meeting in Copenhagen is The Greece meeting was a hit both scientifically approaching rapidly now. The meeting covers 4 as well as financially. No doubt this will be also pre-conference courses (adaptive designs, the case for the Copenhagen meeting, as many discrete longitudinal data, Bayesian methods past ISCB meetings and gradually we are and non-inferiority trials), 5 ordinary invited becoming again a financially healthy Society. I sessions (data monitoring during trials, adaptive say this with great pleasure because in my first trials, causal models, non-randomized trials, year as President I was somewhat worried about genetics, and biomarkers), a large number of the financial state of our Society. Not only the contributed sessions and 3 mini-symposia finances improved but also the Society’s (survival data, design of phase I and II studies membership increased again. So, I can end my and vaccine statistics). And we haven’t second year as a contented President. I hope mentioned the social programme yet. Let it be that you are also pleased with this evolution and clear: there is no excuse to skip this meeting! I am looking forward to meeting you all in Take a look at the Website: Copenhagen. http://www.iscb2008.info/ and you will be convinced that you and your colleagues must be in Copenhagen from 17 to 21 August.

ISCB29 Copenhagen 2008: AGM Agenda

From Harbajan Chadha-Boreham The Annual General Meeting (AGM) will be held on Wed 20 August 1200-1300 in the Auditorium 1 of the ISCB29 Conference Site, Copenhagen. The agenda is the following: 1. President's report 2. Treasurer's report 3. Subcommittee reports and motions for continuation: Statistics in Regulatory Affairs, National Groups, Education, Student Conference Awards, Conference Organising, Membership, Vaccines 4. Future ISCB meetings: 2009 Prague, 2010+ 5. Nominations 5. Any Other Business ALL participants of the meeting, even newcomers to ISCB are, by definition, full ISCB members and are most welcome to attend the AGM. Please take part!

ISCB Constitution: Proposed Revisions

From David W. Warne & Emmanuel Lesaffre As announced at last year’s AGM and in the December News, we are planning to revise the Society’s Constitution. The proposed changes were placed on the Society’s website for consultation [http://www.iscb.info/index.php?module=ContentExpress&func=display&ceid=17&bid=22&btitle=Information&meid=18] and review from January-February 2008 and were generally considered to be a good idea. Thanks to the ISCB Members who provided helpful comments and advice which was taken into consideration. Also legal advice was sought for some tricky aspects. The changes will be put to the membership for approval later this year at the same time as the postal vote for the ExCom.

ISCB News #45 Page 3 June 2008

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ISCB News #45 Page 4 June 2008

ISCB29 Copenhagen 2008: Conference Awards for Scientists (CAS)

From Julia Singer This year there were 8 applications from 7 countries (Bangladesh, Hungary, India, Mexico, Poland, Romania and Sri Lanka). There was a change in the terms of reference compared to previous years: not only the abstract but the whole poster (or presentation) had to be submitted. By this change, it is hoped that the quality of submissions can be better assessed. The award was granted for 6 abstracts. The authors of the award-winner abstracts are (in alphabetic order): Felix Almendra-Arao Mexico Comparison of Significance Levels for the Farrington-Manning Test Atanu Biswas India Multi-treatment location-invariant optimal response-adaptive designs for continuous responses Nashid Kamal Bangladesh Determinants of Contraceptive Use in Urban slums of Bangladesh: A Multilevel Model Analysis Gabriella Magyar Hungary Performance of inter-subject CV% calculations - A simulation study Roshini Sri Lanka Analysis of a Clinical Trial with Single and Multiple Dose Treatments Sooriyarachchi Krystyna Szafraniec Poland Acute health effects of particulate matter pollution in the population of Krakow, Poland

ISCB29 Copenhagen 2008: Student Conference Awards (SCA)

From KyungMann Kim

There were 12 Student Conference Award (SCA) applications, five students from UK, two each from Belgium and US, and one student each from Cameroon, India and Germany. Four students were selected by the SCA subcommittee (Chair, KyungMann Kim; Members, Bruno Cesana, Jan Lanke, Bianca de Stavola and Vana Sypsa) based on the submitted abstract and summary of the paper. Besides the SCA subcommittee members, Program Chair, Philip Hougaard, and ISCB President, Emmanuel Lesaffre, participated in the review of the applications and the selection. I would like to take this opportunity to thank the Subcommittee members and Philip and Emmanuel for their contribution. The Subcommittee would also like to thank the ISCB Officers to allow us to select one more student than usual for the award. This year’s Student Conference winners are given below along with their affiliation and the title of presentation: University of Proportional subdistribution hazards modeling offers Nadine Grambauer Germany Freiburg a summary analysis, even if mis-specified

Lancaster An adaptive phase II/III clinical trial design with Thomas Hamborg UK University subpopulation selection

University of Dose selection in seamless phase II/III clinical trials Peter Kimani UK Warwick based on efficacy and toxicity

Temple A new partial likelihood for the Cox proportional Liyuan (Larry) Ma USA University hazards model

Please join me in congratulating them. I look forward to seeing their presentations during the Conference and hope to see as many of you during the contributed sessions of their presentations.

ISCB News #45 Page 5 June 2008

Book Review by Herwig Friedl (Austria)

Murray Aitkin, Brian Francis and John Hinde Statistical Modelling in GLIM 4 Oxford (2005) 0-19-852413-7

This is a new edition of a book which was first published in presentation again, which even allows considering a 1989. It substantially differs in many respects from the proportional hazards model. Details of the respective original edition. There are now almost 200 pages more than maximum likelihood fit and examples are given in order to the first edition. Most of these additional pages are spent on demonstrate how the GLM fitting process can be used for this three new chapters, which are “finite mixture models”, purpose. “random effect models”, and “variance component models”. Chapter 7 is a totally new one and introduces into the Another important aspect is that the authors have reduced concept of finite mixtures. Maximum likelihood estimation of the amount of text to introduce the program GLIM and to the parameters is then based on the application of the EM describe its syntax. algorithm. Sections on how to compute standard errors and Chapter 1 is dedicated to familiarize the reader with the on testing the number of necessary components in the statistical package GLIM4. This seemingly old-fashioned but mixture are included. This theory is then applied on real data still extremely powerful little piece of software provides lots of by making use of a GLIM4 macro package, which has been facilities which are so helpful to fit generalized linear models especially designed for such kind of models. Also shown is the (GLMs). It is a command-driven package and is designed to connection of a mixture model to kernel density estimation of allow for an interactive modelling process. The handling of the a density and how such an estimate could be calculated and provided functions, which presents the set of commands and achieved in GLIM4. are called macros in GLIM, can be learned relatively quickly In the following chapter 8 the application of mixtures in and it is pretty easy to extend this standard collection by random effect models is considered. There are models writing your own ones. To base a book on statistical included which allow for individual random effects in each modelling on GLIM and not on any other software has several linear predictor, and which are often called random intercept reasons. The most important one is because some of the models or random coefficient model. The authors started their authors have been personally involved in the development of discussion with considering conjugate random effect models, GLIM4. Another aspect is that all the statistical modelling i.e. normal-normal, negative-binomial, and beta-binomial topics covered in the book have been chosen such that these distribution for the responses. They provide again special models can be fitted within GLIM4, which was originally macros for these fits and show how these macros are applied designed to fit GLMs only. in practice. Then they concentrate on normal random effects Chapter 2 is about statistical modelling and inference and and on the usage of the Gauss-Hermite quadrature method to introduces the likelihood concept and its role in parameter get approximations of the EM objective function. If the estimation and hypothesis testing. It provides a random effect distribution can not be assumed to be normal, comprehensive treatment of the theory and concepts of GLMs a nonparametric maximum likelihood (NPML) approach yields and also provides a thoroughly derivative of the iterative both, estimates of the parameters in the predictor as also an estimation procedure. In between, the authors refer to the estimate of the random effect distribution, which was respective GLIM4 directives such that the reader is considered to be fully unknown. This is indeed a very immediately able to recognize the connection between this attractive way to model such data as shown in the following theory and its implementation in the software. series of examples. But also models with additional random Classical linear regression and the analysis of variance is slopes in the predictor can be handled within this fitting then discussed in chapter 3. This is done by using real data process. and by analyzing them within GLIM4. Lots of ideas which are The last chapter of this book is devoted to a rather natural so useful for diagnostics and for model criticism are clearly extension of the previously developed theory of random presented and their usage to detect various misspecifications parameter models. It is about variance component models of parts of the model is discussed in detail. Also included in where the random effects are considered to be shared by this chapter is a review of the Box-Cox family and how this some of the responses as in models for repeated transformation can be realized within GLIM4. What follows measurements. The theory of normal-normal models is goes far beyond the content of a standard textbook on this discussed and then extended onto the linear exponential topic and impressively proves that the authors are really family. Surprisingly, it is again pretty easy to apply the NPML experts in this field. It exhibits a source of various interesting technique for these models whereas other estimation ideas and the reader always feels to be inspired. procedures would require additional effort. This represents Chapter 4 is on models for binary response data. now a huge class of models and the authors discuss some of Transformations of the success probabilities by applying the most important members in theory as also by means of different link functions, ideas for model criticism, and various the analysis of interesting real data examples. practical applications are presented herein. Also extensively What I really like in this book is the clear way in which such discussed in theory and by applications is the relationship of models are presented to the readers. Its clarity is convincing such data with contingency tables, even of several and the book is well organized such that it is really easy to dimensions. recommend the book to anyone who is interested in this kind The following chapter is on multinomial and Poisson response of models. It could be even used as a self-teaching manual by data. This includes models for count data as also for multi- students or by researchers working in various applied fields. categorical responses. However, since GLIM4 is only designed The book is definitely much more than only a manual on to be used for univariate responses, the authors nicely GLIM4. It is a collection of interesting ideas in statistical provide all necessary theory to understand the relationship modelling, what is possible to do within GLIM4, and how is between univariate Poisson variables and multivariate can be realised in practice. Of course, an alternative product multinomials. Even models suitable for ordered response like R also offers a function “glm” and is thus at least similar categories are discussed subsequently and some examples of powerful. Maybe the authors will take this challenge and more complicated data structures are given. write a book in which they demonstrate how their ideas can Like already in the original first edition a very interesting be realized within R. When I recently tried to find these chapter on survival data analysis follows now. It starts with GLIM4 macros somewhere on the web, I already found some the exponential distribution and its role in survival analysis. of their R versions instead. As an example I like to mention Based on the analysis a real dataset it is shown how such a the R package “npmlreg” which provides the functions model can be fitted in GLIM4 and what sort of diagnostics is “alldist” for over-dispersion models and “allvc” for variance available. Then the concept of censored observations is component models. introduced and the respective likelihood function is derived. I strongly recommend this book due to all reasons I have The use of the Poisson likelihood for censored and mentioned above and I am happy to have it already on my uncensored exponential survival times allow for fitting the bookshelf. hazard rate by a Poisson model. But also models based on the References: lognormal, gamma, Weibull, or (reverse) extreme value M. Aitkin, D. Anderson, B. Francis, and J. Hinde (1989). distribution can be considered and it is shown how these Statistical Modelling in GLIM. Oxford University Press. models are fitted in GLIM4. It is the Poisson likelihood

ISCB News #45 Page 6 June 2008

ISCB Education SC: Course Report

From Mike Campbell and Rumana Omar

In April 2008, Mike Campbell and Rumana Omar Delegates at cluster trials course, Isfahan. Mike is in were invited to give a course on cluster randomised blue shirt with Rumana on his right: trials in Isfahan, Iran on behalf of the ISCB. Iran is a large country, with a population of over 70 million and an area larger than the UK, France, Germany and Spain combined. However it is difficult to get in, and Rumana had to visit the Iranian Embassy in London five times to secure our visas! The course almost finished before it started. We turned up to Heathrow on a Saturday to catch the 21.30 plane to Tehran, to be told it had departed at 18.45! The airline BMI had switched to its summer schedule without telling us. The next available flight was the same time the following day, so we were faced with an unexpected stop in London. Urgent emails and phone calls followed and the course was rearranged. The following day we set off, and arrived in Tehran at about 4am on Monday morning. We were met by a taxi driver to take us the 220 miles to We were put up in the magnificent Abbasi hotel, which Isfahan. Dawn came up suddenly to reveal a bleak dates from the 16th century, when Isfahan was at the landscape of scrub and rocks. However the road was height of its prosperity and a major stopping point on well engineered and the driver kept a steady 80 mph. the Silk Road to China. Set in the centre of Isfahan, it He had probably been up all night, since he had great surrounds a large and beautiful garden where one can difficulty staying awake, and kept nodding off. This take tea and admire the lovely trees. This provided a had the effect of keeping his passengers wide awake, welcome break from the lecturing! After the course, our despite jetlag! Luckily, a suggested stop for tea (chai) hosts kindly organised a sight seeing tour around some woke him up and, despite a few detours to avoid road of Isfahan’s magnificent Persian/Islamic architecture, in tolls (and getting lost) we arrived safely mid morning particular the Naghsh-e Jahan Square, surrounded by in the landscaped campus of Isfahan University. mosques and palaces and the Si-o-She Pol (33 arch) Fortunately our hosts, Mohsen Hosseini and bridge. We also visited a some wonderful art and carpet Muhammad Maracy had thoughtfully arranged some shops. rooms where we could shower and take a nap before we started the course after lunch. Mike and Rumana relaxing in the Abbasi Hotel: Our hosts and Rumana Omar demonstrating her unaccustomed head wear:

To Western eyes, Iran has some interesting contrasts. All women have to wear head scarves (but not burkahs), including those who come from Europe to teach The course was given in a large semi-circular lecture statistics! Our null hypothesis that all head scarves had room in the Medical School in Isfahan. We had an to be black was, however, refuted quite quickly. Very few audience of about 30, a mixture of epidemiologists places take credit cards, so cash was important. There and statisticians, men and women, who had come was no alcohol which, given the state of the roads and from all over Iran for the course. Their standard of the driving, is probably just as well! English was high, and the level of questions quite sophisticated. We rearranged the timetable and by All in all, we were grateful to ISCB for offering us the working rather later each day, shortening the opportunity to visit this fascinating city, and to our practical time and cutting out some group work, we Iranian hosts for making the stay in Iran so pleasant managed to fit the two day course into one and a half and trouble free. days. The evaluation at the end of the course was very positive and should lead to some further collaborations.

ISCB News #45 Page 7 June 2008

ISCB Financial Update from the Treasurer

From Koos Zwinderman

Report on the ISCB finances in 2007 Appendix I: Financial Report at December 2007 2007 2006 A summary of the financial position of the ISCB is Euro Euro given in Appendix I; it will be discussed at the ExCom Income meeting and the Annual General Meeting in August Membership fees 21,380.00 23,573.00 2008 in Copenhagen. At this moment, the accounts Conference surplus 42,454.53 30,367.00 are being audited by Ernst & Young, Statsautoriseret Course surplus 606.00 Advertising 2,850.00 2,300.00 Revisionsaktieselskab, Copenhagen, but their Earned interest 1,576.03 1,333.32 approval is not yet available. Currency gains 24.98 10.85 Total income 68,891.54 57,584.17 Nevertheless, it is clear that the financial position has Expenditure further improved during 2007 with a surplus of Permanent Office: €27,889. This surplus is totally due to the success of Consumables 6.71 56.23 Postage & freight 241.27 148.64 the 2007 conference in Alexandroupolis. The Telecommunication & internet 1,800.73 1,526.17 conference ended with a surplus of €42,452 Printing & photocopying 87.53 77.10 (Appendix II). The finances and accounts of the Administration 11,190.64 11,183.92 Alexandroupolis congress were audited and approved 13,327.52 12,992.06 Officers & ExCom: by our member, Fotios Siannis, as internal reviewer, Conference fees 2,500.00 3,145.00 according to §10.07 of our Constitution. Both reports Accommodation 2,828.01 were approved by the Officers of the ISCB. Travel expenses 4,123.35 746.10 Other expenses 134.95 61.46 It is noteworthy to mention that the Society’s 6,758.30 6,780.57 finances depend heavily upon a successful Awards (Students, Scientists): conference; this is clear because the membership Conference fees 3,570.00 4,057.00 Accommodation 2,808.00 2,584.00 (Figure 2) of the Society mainly consists of Travel expenses 2,322.87 786.21 participants to our conference, but next to that, the Other expenses 237.76 conference needs to have a surplus of about €16,000 8,700.87 7,664.97 for the Society to break even. President’s Invited Speaker Conference fees 314.00 Due to the 2007 surplus, the equity position of the Accommodation 189.00 ISCB has improved to €121,000. This is a very Travel expenses 347.28 850.28 promising development, but it still falls short of our Workshops / Courses: goal to have equity of about €150,000. This figure is Honorarium 1,225.00 based on the possibility that we are faced with the Accommodation 392.34 Travel expenses 743.51 328.01 cancellation of a conference with accountability for 743.51 1,945.35 all the costs. Newsletter: Therefore, I recommend to maintain the economy Office expenses 8,043.43 6,311.36 Editorial expenses measures decided in 2002, until we have reached our Travel expenses above-mentioned aim. 8,043.43 6,311.36 Other items: Bank charges 1,039.31 1,205.33 Appendix II: ISCB28 - Alexandroupolis 2007 Audit 1,680.00 1,680.00 Congress Accounts € Currency loss 442.08 155.60 Outstanding payment, Geneva conference Income: Totals 267.00 2006 Registration fees 113,120.00 3,428.39 3,040.93 Pre-Conference Courses 17,150,00 Total expenditure 41,002.02 39,585.52 Sponsoring 26,640.00 NET INCOME: 27,889.52 17,998.65 156,910.00 Assets Expenses: Bank accounts: Congress organisation, incl. rooms 18,654.00 Barclays Euro account 26,170.52 19,947.98 Nordea DKK account 53,864.95 8,144.77 PCO Services, Printing, LOC and SPC 46,580.65 Nordea Euro account 26,767.41 28,285.53 Social Events 5,000.00 Bonds, Danish Shipbuilding Fund 2007 44,226.62 Catering 26,744.00 106,802.88 100,604.90 Invited Speakers 17,476.82 Others: 114,455.47 Accounts receivable 1,075.40 Alexandroupolis conference 2007 26,995.36 Congress Balance 26,995.36 1,075.40 Income 156,910.00 Total Assets 133,798.24 101,680.30 Expenses 114,455.47 Liabilities Congress Surplus 42,454.53 Owing to Permanent Office 10,927.43 6,659.01 Audit 1,680.00 1,680.00 Prepayment account, members 320.00 360.00 Total Liabilities 12,927.43 8,699.01 Assets less Liabilities 120,870.81 92,981.29

EQUITY brought forward 92,981.29 74,982.64 Profit by 31 December 2007 27,889.52 Profit by 31 December 2006 17,998.65 EQUITY carried forward 120,870.81 92,981.29

Conversion rates: 31-12-2006 DKK/EUR 745.60 GBP/EUR 1,4978 31-12-2007 DKK/EUR 745.66 GBP/EUR 1.3977

ISCB News #45 Page 8 June 2008

ISCB Financial Update (continued)

Audit of the 28th ISCB Conference Figure 1 The 28th ISCB conference was held between 29 July and 2 August 2007 in Alexandroupolis, Greece. The ISCB Equity arrangements of the conference were done partly by the L.O.C. and partly by Triaena Tours and Congress Equity Congress Level SA. I was presented with documents confirming the Trend after 2001 expenses and the incomes of the conference. After close inspection of all the documents, everything 200 appeared to be in order. Some minor comments are: • In a receipt related to DHL courier, DHL provided 150 with a summary receipt of all their transactions with 100 Triaena tours during the days of the conference, 50 including transactions unrelated to the conference. As a result, it was extremely difficult to calculate the EUR 1,000] [in 0 expenses related to the conference. The resulting discrepancy, however, of approximately €37 was in favour of the conference. 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 • Many refunds of travel expenses for invited Year speakers were augmented by bank fees, something not easily noticed. The fees were of the order of €12- Figure 2. ISCB Membership 20 per transaction. • In the section of L.O.C. expenses miscellaneous, the amount of €6,500 was included as an estimate for the expenses of the future ISCB LOC closing meeting (tickets and accommodation) and meeting with the SC chair. As a result, no receipt was available. • In the Audiovisual equipment and Technical assistance expenses, the amount of €6,500 was spent as allowances for students that assisted in running the conference. No receipt was available but the LOC assured that personal acknowledgements from the students that received the money can be presented on request. Athens, 31/03/2008 Internal Auditor: Fotios Siannis, Department of Mathematics, University of Athens, Panepistemiopolis, Athens 15784, Greece

ISCB members by country 18-12-2007 AUSTRALIA 11 ROMANIA 30 AUSTRIA 16 RUSSIA 1 BELGIUM 32 SINGAPORE 2 CANADA 19 SLOVAKIA 2 CHILE 1 SLOVENIA 5 CUBA 1 SOUTH AFRICA 3 CZECH REPUBLIC 36 SPAIN 8 DENMARK 34 SRI LANKA 1 ESTONIA 1 SWEDEN 19 FINLAND 8 SWITZERLAND 28 FRANCE 41 TURKEY 4 GERMANY 48 UNITED ARAB EMIRATES 1 GREECE 50 UNITED KINGDOM 117 HUNGARY 44 USA 62 INDIA 3 IRAN 5 Total 800 ISRAEL 2 ITALY 24 Ordinary members 495 19,800 Euros JAPAN 27 Student members 79 1,580 KOREA REPUBLIC OF 1 National Group members, 166 0 LUXEMBOURG 1 non-paying MALAYSIA 1 Newsletter members* 4 0 NETHERLANDS 41 Non-paying members 56 0 NEW ZEALAND 2 NORWAY 12 Total 800 21,380 Euros POLAND 54 PORTUGAL 2

ISCB News #45 Page 9 June 2008

Book Review by Andreas Ziegler (Germany)

Feifang Hu and William F. The Theory of Response-Adaptive Randomization in Clinical Wiley (2006) Rosenberger Trials 0-471-65396-9

Response-adaptive randomization uses accruing material can also be found. I therefore absolutely data to skew the allocation probabilities to favour agree with these claims of the authors, and the the treatment performing better thus far in the book is appropriate for a one semester course on trial. This contracts, however, with clinical response-adaptive randomizations if problems and guidelines which state that “dynamic allocation is solutions are added by the course instructor. strongly discouraged” (CPMP 2003). Although this The organization of the book is intuitive. After a clear recommendation is related to the adjustment short introduction to randomization procedures of baseline covariates, it directly applied to and the history of response-adaptive response-adaptive randomization. Because I was randomization, the authors explain the interested in the arguments of the authors why fundamental questions of response-adaptive and when response-adaptive might be superior to randomization in chapter 2. Chapter 3 deals with the standard conduct of clinical trials without any likelihood-based inference from response-adaptive dynamic allocation, I wanted to have a closer look randomization. In chapters 4 and 5 they describe at the book written by the leading experts in the response-adaptive procedures based on urn area of response-adaptive randomization. models and sequential estimation. Here, Nevertheless, I was a little bit fearful when I sequential estimation refers to approaches in received this book for review. First, it has been which parameters affecting target allocation are published in the excellent but sometimes quite modified in the course of a study. Thus, the term technical Wiley Series in Probability and sequential estimation is different from its use in Statistics. Second, the first lines on the back of group sequential studies. As already mentioned the book cover start with “presents a firm above, chapter 6 deals with sample size and power mathematical basis …”. When I had a closer look calculation which is subtle because of random at the book, I was extremely positively surprised. sample fractions. Practical issues are discussed in First of all, the notation used is very clear. chapters 7 and 8. These include aspects like Second, the underlying didactical structure is delayed response or heterogeneity or the choice of clearly recognizable. a specific response-adaptive procedure. Before To give an example, in the chapter on sample size open problems for future research are discussed calculations (chapter 6), the authors give a in chapter 10, the authors nicely summarize their reasoning why this topic is important in the first current knowledge of covariate adjusted adaptive- sentence. They next quote Friedman and randomization procedures in chapter 9. What I colleagues (1998) who stated that sample size found interesting was the varying length of the calculation is an essential part of planning. different chapters. In fact, while the longest has Thereafter, they explain in very few sentences the 36 pages, the shortest is only 6 pages long. This difference between sample size calculation in substantial variability is, however, natural and common clinical trials and studies employing just right. response-adaptive randomization. They finally All in all, it is easy to strongly recommend this require only one sentence in the introductory book, and it should not be missing in the remarks of this chapter to explain the topic of the bookshelf of biostatisticians interested in subsequent sections. Concise introductions are response-adaptive randomization. given in a similar way for the other chapters of the book. References The book is aimed for Ph.D. students and CPMP (2003). Points to Consider on Adjustment for researchers in mathematics, statistics and Baseline Covariates. CPMP/EWP/2863/99. biostatistics. Furthermore, the authors state that Friedman LM, Furberg CD, DeMets DL (1998). most of the book is written on the graduate level. Fundamentals of Clinical Trials. Springer: New Indeed, most of the technical portions have been York. relegated to appendices, where prerequisite

ISCB News #45 Page 10 June 2008

Elections for the Executive Committee 2009-10: Final Warning!

From John Whitehead, Chair of the Nominations Committee

In accordance with the Constitution, we ask for nominations for positions on the Executive Committee for 2009-10. At the end of 2008, the situation will be:

Emmanuel Lesaffre Will end his term as President and becomes Past President for one year, 2009. Norbert Victor Will become President for two years, 2009-10, and Past- President for 2011. Harbajan Chadha-Boreham Will end her 2nd term as Secretary and is not eligible for re-election as Secretary or Treasurer but could be elected as Vice President. Koos Zwinderman Ends his 1st term as Treasurer and is eligible for re- election as Treasurer, Secretary or Vice President. Rumana Omar, Catherine Quantin, End their 2nd terms as Ordinary members and are not Jeno Reiczigel, Marie Reilly, eligible for re-election as Ordinary members, but are Martin Schumacher & Vana Sypsa eligible for re-election as Treasurer, Secretary or Vice President. Adriano Decarli, KyungMann Kim End their 1st terms as Ordinary members and are eligible for re-election as Ordinary members, or as Treasurer, Secretary or Vice President. David W Warne Wishes to continue as News Editor. Bjarne Nielsen Wishes to continue as Webmaster. For the end of term it is meant the end of the calendar year (2008).

Nominations for If there are more nominees than vacant • Vice President, positions, an electronic ballot will be held. • Secretary, Please note the following clauses from the Constitution: • Treasurer and “(6.02) The Committee shall consist of the • 8 ordinary members four Officers and at least five but not more are therefore sought. than eight other members (“Ordinary To make a nomination, please download the members”), plus the Past President, who form from the web shall serve only for the calendar year [http://www.iscb.info/iscbdocs/Template_N immediately following the Presidency, and omination_2008.doc] and send it to the co-opted members.” Chair of the ISCB Nominations Committee, “(6.03) The Ordinary members, who shall be John Whitehead, (j.whitehead@ Members for at least the calendar year prior Lancaster.ac.uk). Each nomination will to nomination, must be elected by ballot; require the signatures of the Proposer, a their full term of office shall be two calendar Seconder and of the Nominee confirming a years and they shall be eligible for re-election willingness to serve. Completed and signed for one further full term up to a maximum of nomination forms must be received no later four consecutive calendar years.” than 31 August 2008. (Faxed or scanned forms are acceptable.)

ISCB News #45 Page 11 June 2008

Books for Review by Sylvain Larroque

Books for review: Author(s) Title Publisher (year) ISBN Reviewer 1. David A. Freedman Statistical Models, Theory and Cambridge (2005) Practice 780521671057 2. Brian D. Ripley Stochastic Simulation Wiley, 1987 (2006) 0-470-00960-8 3. A. C. Atkinson, A. N. Donev Optimum Experimental Designs, Oxford (2007) and R. D. Tobias with SAS 978-0-19-929660-6 4. Bill Thompson The Nature of Statistical Springer (2007) Evidence 978-0-387-40050-1 5. Eric Stallard, Kenneth G. Forecasting Product Liability Springer (2002) 0387949879 Manton and Joel E. Cohen Claims 6. William M. Bolstad Introduction to Bayesian Wiley (2007) 978-0-470-14115-1 Statistics (Second Edition) 7. J. Rick Turner New Drug Development: Design, Wiley (2007) 978-0-470-07373-5 Methodology, and Analysis 8. Richard Kay Statistical thinking for Non- Wiley-Blackwell (2007) Statisticians in Drug Regulation 978-0-470-31971-0 9. D. C. Hoaglin, F. Mosteller Exploring Data Tables, Trends, Wiley (2006) 0-470-04005-x and J. W. Tukey and Shapes Books recently sent for review: Author(s) Title Publisher (year) ISBN Reviewer 1. A. C. Davison Statistical Models Cambridge (2003) Harry Southworth 780521773393 2. Christopher M. Bishop Pattern Recognition and Springer (2006) 0-387-31073-8 Christos Nakas Machine Learning Books reviews in this issue: Author(s) Title Publisher (year) ISBN Reviewer 1. Feifang Hu and William F. The Theory of Response- Wiley (2006) 0-471-65396-9 Andreas Ziegler, Germany Rosenberger Adaptive Randomization in Clinical Trials 2. Murray Aitkin, Brian Statistical Modelling in GLIM 4 Oxford (2005) 0-19-852413-7 Herwig Friedl, Austria Francis and John Hinde 3. Tomasz Burzykowski, Geert The Evaluation of Surrogate Springer (2005) 0-387-20277-3 Tim Friede, UK Molenberghs and Marc Endpoints Buyse (Editors) 4. John Aitchison, Jim W. Kay Statistical Concepts and Chapman & Hall/CRC (2005) Denis Enachescu, Romania and Ian J. Lauder Applications in Clinical Medicine 1-58488-208-5 5. Jayanta K. Ghosh, Mohan An Introduction to Bayesian Springer (2006) Marek Brabec, Czech Republic Delampady and Tapas Analysis: Theory and Methods 978-0-387-40084-6 Samanta 6. R. A. Maronna, R. D. Martin Robust Statistics: Theory and Wiley (2006) 0-470-01092-4 Sada Nand Dwivedi, India and V. J. Yohai Methods 7. Naomi B. Robbins Creating More Effective Graphs Wiley (2005) 0-471-27402-X Gaj Vidmar, Slovenia

Important note to potential reviewers: We regularly receive books from publishers for review Please do a little work in return for keeping the book in the Newsletter. We are most grateful for these and your name will be published in the News! “donations”, the reviews of which we regard as a For the format and length, please see recent issues of service to you, our members. Regretfully, some ISCB News. You can send the review in a variety of individuals, despite repeated reminders, neither formats but plain text email, html, RTF or Word are return a review, nor the book to ISCB... When preferred. The reviews may be edited for clarity requesting a book, please remember that you’re (English grammar and spelling, punctuation etc.). making a commitment to the Society to do a little work in return for keeping the book.

ISCB News #45 Page 12 June 2008

Books for Review (continued)

Books sent for review quite a long time ago

Author(s) Title Publisher (year) Reviewer

1. H. Brown and R. Prescott Applied Mixed Models in Wiley (2006) 0-470-02356-2 Marie Reilly, Sweden Medicine (Second Edition)

2. Frank R. Hampel, Elvezio Robust Statistics: The Approach Wiley (2005) 0-471-73577-9 Lars Krogsgaard Thomsen, M. Ronchetti, Peter J. Based on Influence Functions Denmark Rousseeuw and Werner A. Stahel

3. J. Edward Jackson A User's Guide to Principle Wiley (2003) 0-471-47134-8 Nicole Close, USA Components

4. J M Bernardo et al (eds.) Bayesian Statistics 7 Oxford University Press (2003) Stefan Tigan, Romania 0-19-852615-6

5. Jean Dickinson Gibbons Nonparametric Statistical Chapman & Hall/CRC, (2003) Elisabeth Svensson, Sweden and Subhabrata Inference (Fourth Edition) 0-8247-4052-1 Chakraborti

6. John Verzani Using R for Introductory Chapman & Hall/CRC (2005) Justin Clayton, USA Statistics 1-58488-450-9

7. Shein-Chung Chow, Jun Sample Size Calculations in CRC (2003) 0-8247-0970-5 Jorgen Seldrup, France Shao and Hansheng Wang Clinical Research

8. Marc Aerts, Helena Geys, Topics in Modelling of Clustered Chapman & Hall/CRC (2002) S.H. Heisterkamp, Netherlands Geert Molenberghs and Data 1-58488-185-2 Louise M. Ryan

9. Andreas Ziegler and Inke R. A Statistical Approach to Wiley (2006) 3-527-31252-8 Victor Moreno, Spain Konig Genetic Epidemiology

Book publishers’ webpages: Hodder Arnold http://www.hoddereducation.co.uk/Category/8717/Statistics.htm

Blackwell http://www.blackwellpublishing.com/subjects/PB/

Cambridge University Press http://www.cambridge.org/uk/browse/default.asp?subjectid=1007745

Chapman & Hall, CRC http://www.crcpress.com/shopping_cart/categories/categories_products.asp?parent_id=104

Marcel Dekker (Taylor and http://www.dekker.com/sdek/browse~thing=content~by=treesubject~stem=0 Francis) ~append=713326283~selected=713326283

Oxford University Press http://www.oup.co.uk/academic/science/maths/

Springer http://www.springer.com/east/home/statistics?SGWID=5-10128-0-0-0

John Wiley & Sons http://www.wiley.com/WileyCDA/Section/id-300665.html

ISCB News #45 Page 13 June 2008

ISCB29: Copenhagen, Denmark: Draft Programme

From Philip Hougaard, SPC Chair, and Bjarne Nielsen, LOC Chair

Copenhagen City

Conference Venue: Royal Academy of Fine Arts - School of Architecture Philip de Langes Allé 10 DK-1435 Copenhagen K www.karch.dk/uk

Central Railway Station

Statens Serum Institut To the airport Mini-symposium 3

ISCB News #45 Page 14 June 2008

ISCB 29 Copenhagen 2008: Draft Programme 29th Annual Conference of the International Society for Clinical Biostatistics Copenhagen, Denmark 17-21 August 2008 www.iscb2008.info INVITATION AND WELCOME

Dear Friends and Colleagues,

On behalf of the International Society for Clinical Biostatistics (ISCB) and the Local Organising Committee, it is a great pleasure to invite you to attend the 29th annual conference in Copenhagen, August 17-21, 2008. The conference is held as a joint arrangement in the Øresund region (the areas of Sweden and Denmark next to the Strait of Øresund) also called Medicon Valley due to its high level of research activities within biotech and life science. The conference logo is the bridge between Denmark and Sweden to illustrate cooperation, and because we hope that the conference will create relations between scientists and facilitate the exchange of ideas.

The conference will be held in the old buildings of the School of Architecture just behind the new Opera and on the water front opposite the Royal Palace. We are preparing an interesting scientific programme. Apart from the scientific programme you can look forward to summer in Copenhagen, an old city with character and charm, cultural events, extensive green areas - a beautiful relaxed setting for social interaction with colleagues and sightseeing.

We all look forward to seeing you in Wonderful Copenhagen.

Bjarne Nielsen Philip Hougaard Chair, Local Organising Committee Chair, Scientific Programme Committee

ISCB News #45 Page 15 June 2008

ISCB 29 Copenhagen 2008: Draft Programme 29th Annual Conference of the International Society for Clinical Biostatistics Copenhagen, Denmark 17-21 August 2008 www.iscb2008.info ISCB 29 – Copenhagen – Denmark 2008 – Provisional Programme Outline Sunday 17 August Monday 18 August Tuesday 19 August Wednesday 20 August Thursday 21 August 08.00 Registration Registration Registration Registration Registration 08.00 Pre‐conference courses: 09.00 1: Sequential and 2: Models for 3: Bayesian ‐09.20 Welcome Invited Contributed Invited Contributed Mini‐Symposium Mini‐Symposium Mini‐Symposium 09.00 adaptive designs discrete methods for session sessions session sessions 1* 2** 3*** Invited session for clinical trials longitudinal data biostatistical Recent Design of Statistics in applications Developments in Phase I & II Vaccines Survival Data Studies Research 10.30 Refreshments Refreshments Refreshments Refreshments Refreshments Refreshments Refreshments 10.45 11.00 1: Sequential and 2: Models for 3: Bayesian Invited Contributed Invited Contributed Keynote lecture adaptive designs discrete methods for session sessions session sessions Mini‐Symposium Mini‐Symposium Mini‐Symposium 11.15 for clinical trials longitudinal data biostatistical 1* 2** 3*** applications 12.00‐13.00 Recent Design of Statistics in Annual General Meeting 12.30 Lunch Lunch Developments in Phase I & II Vaccines Survival Data Studies Research 12.45 Lunch Lunch 13.00 *) Venue of Mini‐symposium 1: Conference venue Conference ‐ The School of Architecture. Excursions 13.45 1: Sequential and 2: Models for 4: Non‐inferiority adaptive designs discrete trials **) Venue of Mini‐symposium 2: H. Lundbeck A/S, 14.00 Contributed sessions Contributed sessions for clinical trials longitudinal data Ottiliavej 9, Copenhagen Valby. There will be bus shuttle from Copenhagen central railway station to H. Lundbeck in the morning and to 15.30 Refreshments Refreshments Refreshments Copenhagen central railway station at 13:00 hrs. 16.00 1: Sequential and 2: Models for 4: Non‐inferiority Invited Contributed Contributed sessions adaptive designs discrete trials session sessions ***) Venue of Mini‐symposium 3: Statens Serum for clinical trials longitudinal data Institut, Artillerivej 5, Copenhagen S. From Copenhagen central railway station: Line 5a 17.30 (direction: Syndbyvester Plads). From Copenhagen 18.00+ 19.00‐21.00 19.00‐23.00 airport: Line 250S. Welcome reception at Copenhagen Conference dinner at City Hall Restaurant Paafuglen All day Poster Session Poster Session Poster Session

ISCB News #45 Page 16 June 2008

11:00-12:45 PCC 01: PCC 02: Bayesian methods 13:45-15:30 Adaptive designs Models for discrete longitudinal data PCC 04:

16:00-17:30 Non-inferiority trials Monday 18 08:30-10:30 IS 01: Plenary Session, State-of-the-Art Lectures on Data Monitoring in Clinical Trials – Controversies and Conundrums, and Genetic Epidemiology after Genome-wide association studies 11:00-12:30 IS 02: Causal models and evidence from non- CS 03: Categorical data CS 04: Models in epidemiology CS 05: Diagnostic procedures randomised studies 14:00-15:30 CS 06: Models in survival data (part I) CS 07: High-dimensional data CS 08: Dose-finding CS 09: Miscellaneous 16:00-17:50 IS 10: Working places in biostatistics CS 11: Survival data CS 12: Biomarkers (part I) CS 13: Causal models Tuesday 19 09:00-10:30 IS 14: Genetics CS 15: Sequential and adaptive studies CS 16: Competing risks CS 17: Adverse events (part I) 11:00-12:30 IS 18: Biomarkers CS 19: Clinical trials (part I) CS 20: Multi-state models CS 21: Meta-analysis (part I) Wednesday 20 09:00-10:30 IS 22: How to analyse an adaptive trial: Tests, CS 23: Frailty models CS 24: Repeated measurements (part I) CS 25: Genetics estimates and confidence intervals 11:00-12:00 IS 26: Keynote lecture Sampling patterns in event history analysis with applications to epidemiology 12:00-13:00 Annual General Meeting 14:00-15:30 CS 27: Statistical methods CS 28: Non-randomised studies CS 29: Sequential and adaptive studies CS 30: Meta-analysis (part II) (part II) 16:00-17:30 CS 31: Models in survival data (part II) CS 32: Clinical trials (part II) CS 33: Biomarkers (part II) CS 34: Repeated measurements (part II) Thursday 21 09:00-12:45 MS 01: MS 02: MS 03: Recent developments in survival data Design of phase I and II studies Statistics in vaccines research

ISCB News #45 Page 17 June 2008

ISCB 29 Copenhagen 2008: Draft Programme 29th Annual Conference of the International Society for Clinical Biostatistics Copenhagen, Denmark 17-21 August 2008 www.iscb2008.info Pre-conference Courses, Sunday 17 August Course Fee Up to 1 June After 1 June Full day course 300 Euros 350 Euros Full day course/students 150 Euros 200 Euros Half day course 200 Euros 250 Euros Half day course/students 100 Euros 150 Euros

Course 1 (full day): Course 2 (full day): Course 3 (half day, morning): Course 4 (half day, afternoon): Sequential and adaptive designs for clinical Models for discrete longitudinal data Bayesian methods for biostatistical Non-inferiority trials trials applications Presenter: Chris Jennison (University of Bath, Presenter: Geert Molenberghs (Hasselt Presenter: Paul Gustafson (University of Presenters: Simon Day (Roche, UK) and Nicole UK) University, Belgium) British Columbia, Canada) Close (US Army Medical Research and Materiel Command, USA) There has been much recent interest in Starting from a brief introduction on the linear Following a general overview, certain aspects of This course gives an overview of many of the methods to modify the design of a clinical trial mixed model for continuous longitudinal data, the Bayesian approach will be emphasized. To issues faced by those designing, running, at an interim stage, responding to external extensions will be formulated to model considerable extent the focus will be on analysing, presenting and interpreting studies factors or to data observed in the study itself. outcomes of a categorical nature, including concepts and modelling issues, rather than on aimed at showing that a new therapy is ‘no We review the benefits and drawbacks of counts and binary data. Based on Verbeke and technical and computational issues. One worse than’ (from a practical point of view) an adaptive designs from both practical and Molenberghs (2005), several families of models emphasis will be on Bayesian methods applied existing therapy. The presentation will be at a theoretical viewpoints. will be discussed and compared, from an to deal with various limitations often arising very practical level but requires, as a pre- We shall present statistical methodology in the interpretational as well as computational point with data in biostatistical contexts, particularly requisite, a good level of understanding of the unifying framework of combination tests, of view. First, models will be discussed for the in non-randomized studies. Such limitations fundamental principles of clinical trials. The whereby conditional Type I error is maintained full marginal distribution of the outcome include poorly measured variables, unobserved course is relevant to those in the at each adaptation. The first application of vector. Such models allow inference to be confounders, and selection bias. Another pharmaceutical sector as well as those from these methods is in sample size re-estimation, based on maximum likelihood principles, but emphasis will be on the use of the Bayesian government and academia; it will include either to handle a nuisance parameter affecting they have the disadvantage of requiring paradigm to make modelling assumptions less scientific and regulatory issues, with examples sample size or to increase the power based on complete specification of all higher-order rigid. The idea here is that prior distributions taken from the US and Europe. interim estimates of effect size. Here, it is interactions. Two alternatives will be can reflect the notion that key modelling At the end of the course, attendees should appropriate to draw comparisons with group discussed: random-effects models as well as assumptions are only approximately correct understand the purpose and potential benefits sequential methods, which may be used to semi-parametric marginal models with rather than exactly correct. Examples will be of non-inferiority studies and how they differ achieve similar goals. specification of the first moments only, or the drawn from a variety of health research from superiority studies. Attendees should also Other uses of adaptive methods are in first and second moments only. Estimation contexts. understand the extra difficulties associated problems with multiple hypotheses. After and inference will be discussed and illustrated with these types of studies, over and above reviewing methods for multiple testing with in full detail, and it will be extensively argued those of superiority studies. that both approaches yield parameters with protection of the overall type I error probability, we shall survey applications to: completely different interpretations. Finally, when analyzing longitudinal data, one is often Changing the treatment definition; Changing the primary endpoint; Refining the patient confronted with missing observations. It will be shown that, if no appropriate measures are population; Switching between superiority and non-inferiority. taken, missing data can cause seriously biased results, and interpretational difficulties. The final topic will be seamless transition from Methods to properly analyze incomplete data, Phase II to Phase III clinical trials whereby a under flexible assumptions, are presented. Key treatment or dose level is first selected then concepts of sensitivity analysis are introduced. tested in a confirmatory stage, all within one over-arching trial design.

ISCB News #45 Page 18 June 2008

ISCB 29 Copenhagen 2008: Draft Programme 29th Annual Conference of the International Society for Clinical Biostatistics Copenhagen, Denmark 17-21 August 2008 www.iscb2008.info MONDAY, 18 AUGUST 2008 08:00 - 17:30 Registration Time The School of Architecture The School of Architecture The School of Architecture The School of Architecture 09:00 - 09:20 Welcome 09:30 - 10:30 IS01 - Plenary Session, State of the Art Lectures Chair: Philip Hougaard (Denmark) 09:20 - 09:55 Susan Ellenberg (USA): Data monitoring in Clinical trials: Controversies and conundrums. 09:55 - 10:30 David Clayton (UK): Genetic epidemiology after genome-wide association studies. 10:30 - 11:00 Refreshments - Poster & Exhibition Viewing 11:00 - 12:30 IS02 - Invited Session CS03 - Contributed Session CS04 - Contributed Session CS05 - Contributed Session Causal models and evidence from non- Categorical data Models in epidemiology Diagnostic procedures randomised studies Chair: Chair: Chair: Chair: Michal Abrahamowicz (Canada) Leigh Blizzard (Australia): Regression models Yvonne Vergouwe (Netherlands): Aeilko Zwinderman (Netherlands): Statistical 11:00 - 11:30 for estimating relative risk from ordinal Development and validation of a prediction Analysis of Back-to-back Diagnostic Research Miguel Hernan (USA): responses. model with missing predictor data. Comparing Two Diagnostic Tests for Identifying Colonic Lesions. Observational studies analysed like randomised Luwis Diya (Belgium): Relationship between Sebastien Marque (France): An original experiments: the case of postmenopausal nurse staffing and hospital mortality: A multi- strategy of analysis to deal with excess of zero Yohann Foucher (France): An adaptation of hormone therapy and heart disease. centre nursing unit level study using clustered in count data. time-dependent ROC curves to construct a discrete-time logistic model. prognosis test based on the repetition of a 11:30 - 12:00 Willi Sauerbrei (Germany): Modelling Svend Kreiner (Denmark): Analysis of Continuous Variables With a Spike at Zero – a surrogate marker: Application on the kidney Betty Kirkwood (UK): repeated categorical measurements. New Procedure Based on Fractional graft failure and the creatinine clearance. Developing evidence-based policy for public Toshiro Tango (Japan): A latent class mixture Polynomials. John Kornak (USA): Bayesian decision health interventions: overcoming the limits of model combined with proportional odds model Harald Binder (Germany): Modeling analysis for choosing between diagnostic non-randomised evaluations. for repeated measurements in clinical trials. Continuous Covariates by Global and Local procedures. 12:00 - 12:30 Fang Zhu (USA): A sensitivity analysis of Techniques. Frank Dunstan (UK): Statistical models for Stijn Vansteelandt (Belgium): longitudinal discrete outcome data with Nashid Kamal (Bangladesh) (Scientist Award identifying child abuse. Modelling and estimating direct effects. dropouts. Winner): Determinants of Contraceptive Use in M. Rosário de Oliveira (Portugal): Urban slums of Bangladesh - A Multilevel Confidence Intervals for Sensitivity and Model Analysis. Specificity using a Latent Class Model. 12:30 - 14:00 Lunch - Poster & Exhibition Viewing

ISCB News #45 Page 19 June 2008

ISCB 29 Copenhagen 2008: Draft Programme 29th Annual Conference of the International Society for Clinical Biostatistics Copenhagen, Denmark 17-21 August 2008 www.iscb2008.info

MONDAY, 18 AUGUST 2008 Time The School of Architecture The School of Architecture The School of Architecture The School of Architecture 14:00 - 15:30 CS06 - Contributed Session CS07 - Contributed Session CS08 - Contributed Session CS09 - Contributed Session Models in survival data (Part I) High-dimensional data Dose-finding Miscellaneous Chair: Chair: Chair: Chair: Karen Leffondré (Canada): A weighted Cox model Christine Porzelius (Germany): Selecting model Karen Messer (USA): Likelihood-based estimates in Bendix Carstensen (Denmark): Models for Method for case-control data with time-dependent exposures. complexity for high-dimensional survival models. a Phase I/II oncology trial. Comparison Studies. Milada Cvancarova Smaastuen (Norway): Cyril Dalmasso (France): Family contraction for Nigel Stallard (UK): Optimally choosing the number Werner Vach (Denmark): Cohen's kappa as a Weighted Cox regression applied to cancer registry FDR-based strategies in large-scale genomic studies. of treatments in a clinical trial. comparative measure of reproducibility. data – a critical appraisal. M. Rauf Ahmad (Germany): A Two-sample statistic Helene Thygesen (UK): Dose optimizing in drug Robert Newcombe (UK): Propagating imprecision: Ella Huszti (Canada): Incorporating Relative for the analysis of high dimensional repeated combination trials. combining confidence intervals from independent Survival in a Multi-State Markov Model. measures designs. Sarah Zohar (France): Meta-Analysis of Dose- sources Catherine Quantin (France): Validation of a New Jodi Siever (Canada): Exploring principal Finding Studies. Arnold L.M. Dekkers (Netherlands): AGE-MODE, Flexible Spline-based Relative Survival Model. components analysis for graphing repeated measures an Age-Dependent Model for estimating Usual Giuliana Cortese (Italy): Flexible Regression data. Intakes. Models for the Excess Hazard in Relative Survival. Lara Lusa (Slovenia): A Class Comparison Method Ralf Bender (Germany): Interval Estimation of the with Filtering Enhanced Variable Selection for High- Population Impact Number (PIN). Dimensional Data Sets. 15:30 - 16:00 Refreshments - Poster & Exhibition Viewing 16:00 - 17:50 IS10 - Special Invited Session CS11 - Contributed Session CS12 - Contributed Session CS13 - Contributed Session Working places in biostatistics Survival data Biomarkers (Part I) Causal models Chair: Philip Hougaard (Denmark) Chair: Chair: Chair: 16:00 - 16:20 Marco Carone (USA): Nonparametric incidence Ziv Shkedy (Belgium): Selection and Evaluation of Vanessa Didelez (UK): Structural and graphical Michael Branson (Switzerland): estimation from cross-sectional survival data with Genomic Biomarkers for Depression. models. The role of a methodological statistics group in a follow-up. pharmaceutical company. Harbajan Chadha-Boreham (Switzerland): Nuala Sheehan (UK): Inferring causality from 16:20 - 16:38 Georg Heinze (Austria): Conditional logistic Statistical Issues in the Evaluation of Multiple observational epidemiological data. Niels Kamp (Denmark): regression with small or sparse data sets. Medical Diagnostic Tests for a Rare Disease. Thérèse A. Stukel (Canada): Can Statistical Challenges in outsourcing statistical tasks. Carla Moreira (Spain): Extending the Bootstrap Lisbet Groes (Denmark): On the use of biomarkers Methods Remove Selection Bias in Observational 16:38 - 16:56 techniques for doubly truncated data. in clinical development. Studies? Saskia Le Cessie (The Netherlands): Yannan Jiang (New Zealand): Investigating the Pamela Shaw (USA): Methods for Assessing Susanne Stampf (Germany): New Proposals for Working with doctors in a hospital. effects of smoke-free legislation changes on hospital Improvement in Specificity When a Biomarker is Estimating Marginal Odds Ratios by Propensity 16:56 - 17:14 admissions: A discussion of methodology and Combined With a Standard Screening Test. Score Stratification and Logistic Regression. Antonella Bacchieri (Italy): results. Susan Halabi (USA): Sample size calculation for Willem Marco van der Wal (Netherlands): Which qualifications are needed to get a job as biostatistician in the pharmaceutical industry. Noori Akhtar-Danesh (Canada): Survival analysis comparing slopes of a biomarker outcome assuming Optimizing survival by detecting the optimal for large datasets with an application to smoking Missing at Random (MAR). switching time from peritoneal dialysis to 17:14 - 17:32 initiation. haemodialysis in renal patients. Carmen Maria Cadarso Suarez (Spain): Karimollah Hajian-Tilaki (Iran): An extension of Life at a university. Anna Johansson (Sweden): Smoking and infant parametric ROC analysis for calculating diagnostic 17:32 – 17:50 death: a survival analysis of Swedish birth data. accuracy when underlying distributions are mixture Colin Neate (UK): of Gaussian. The significance of clinical statisticians in the pharmaceutical industry. 19:00 - 20:30 Welcome Reception at the City Hall

ISCB News #45 Page 20 June 2008

ISCB 29 Copenhagen 2008: Draft Programme 29th Annual Conference of the International Society for Clinical Biostatistics Copenhagen, Denmark 17-21 August 2008 www.iscb2008.info

TUESDAY, 19 AUGUST 2008 08:00 - 12:30 Registration Time The School of Architecture The School of Architecture The School of Architecture The School of Architecture 09:00 - 10:30 IS14 - Invited Session CS15 - Contributed Session CS16 - Contributed Session CS17 - Contributed Session Genetics Sequential and adaptive studies (Part I) Competing risks Adverse events Chair: Amita Manatunga (USA) Chair: Chair: Chair: 09:00 - 09:30 Thomas Hamborg (UK) (Student Award Winner): Chung-Chou Chang (USA): A survival regression Ting-Li Su (UK): Bayesian decision making to Juni Palmgren (Sweden): An adaptive phase II/III clinical trial design with model for data with competing risks. reduce adverse events in drug development. subpopulation selection. Models for genetic linkage and association based on Paul Lambert (UK): Estimating Cumulative Cause- Martin Kulldorff (USA): A Maximized Sequential family data. Peter Kimani (UK) (Student Award Winner): Dose Specific Mortality in the Presence of other Causes Probability Ratio Test for Drug and Vaccine Safety Selection in Seamless Phase II/III Clinical Trials using Relative Survival Models. Surveillance. 09:30 - 10:00 based on Efficacy and Toxicity. Aurélien Belot (France): Flexible modelling of Ismaïl Ahmed (France): Fisher's Exact Test and Jelle Goeman (The Netherlands): Jixian Wang (Switzerland): Multiple comparisons competing risks in survival analyses. False Discovery Rate Applied to Pharmacovigilance. Testing sets of genes in gene expression studies. after flexible sample size adjustment in multi- Federico Ambrogi (Italy): Estimating crude Silvia Kuhls (Germany): Evaluation of New Alarm 10:00 - 10:30 treatment trials with treatment selection. cumulative incidences through joint modeling on Algorithms in Intensive Care Online Monitoring. Title and Speaker to be determined Atanu Biswas (India) (Scientist Award Winner): cause specific hazards: multinomial and piecewise Michelle Byrtek (USA): Hysteresis and PK-PD Multi-treatment location-invariant optimal response- exponential regression. analysis of QT prolongation: Detection, adaptive designs for continuous responses. Marcel Wolbers (Switzerland): Prognostic models consequences, and modeling alternatives. Fredrik Öhrn (Sweden): Group Sequential Designs with competing risks: Methods and application to for Simultaneous Testing of Superiority and Non- coronary risk prediction. Inferiority. 10:30 - 11:00 Refreshments - Poster & Exhibition Viewing 11:00 - 12:30 IS18 - Invited Session CS19 - Contributed Session CS20 - Contributed Session CS21 - Contributed Session Biomarkers Clinical trials (Part I) Multi-state models Meta-analysis (Part I) Chair: Antonella Bacchieri (Italy) Chair: Chair: Chair: 11:00 - 11:30 Doug Altman (UK): Depicting variation in David Dejardin (Belgium): Joint modeling of Jorn Wetterslev (Denmark): Quantifying Diversity Bob Powell (USA): individual outcomes in reports of randomised trials. progression free survival and death. and Estimating Required Information Size in a Meta- analysis. Disease and Biomarker development at FDA. Stephen Walter (Canada): At what level of risk is a Svetlana Belitser (Netherlands): Markov model to clinical intervention justified? analyse time patterns based on censored data. Jorgen Hilden (Denmark): Cumulative Meta-

Bettina E. Hansen (Netherlands): Dynamic Somnath Datta (USA): Nonparametric comparisons Analyses with an Exact Type I Error Warranty. 11:30 - 12:00 Prediction Models to Update the Response Chance of waiting time distributions in a Markov multistate Ingeborg van der Tweel (Netherlands): Sequential Title & Speaker to be determined During Peg-interferon Treatment of Chronic system under interval censored data. meta-analysis: an efficient and ethical decision- 12:00 - 12:30 Hepatitis B. Gek-Hsiang Lim (Singapore): Parametric estimation making tool. Title & Speaker to be determined Rema Raman (USA): Modeling Site-Specific of event hazards and association - a semi-competing Jack Bowden (UK): A general framework for Screening and Enrolment Rates: A simple method to risks approach. modelling multiple forms of dissemination bias in predict site recruitment in a clinical study. Hans C. van Houwelingen (Netherlands): Dynamic meta-analysis. Kit Simpson (USA): Approaches to Maximize Study Predicting by Landmarking as an Alternative for Gerta Rücker (Germany): The arcsine difference as Power for Economic Endpoints in Fixed Sample Size Multi-state Modeling: An Application to Acute a measure of treatment effect in meta-analysis. Clinical Studies. Lymphoid Leukemia Data. 12:30 - 13:00 Lunch - Poster & Exhibition Viewing 13:00 - Conference Excursions

ISCB News #45 Page 21 June 2008

ISCB 29 Copenhagen 2008: Draft Programme 29th Annual Conference of the International Society for Clinical Biostatistics Copenhagen, Denmark 17-21 August 2008 www.iscb2008.info

WEDNESDAY, 20 AUGUST 2008 08:00 - 17:30 Registration Time The School of Architecture The School of Architecture The School of Architecture The School of Architecture 09:00 - 10:30 IS22 - Invited Session CS23 - Contributed Session CS24 - Contributed Session CS25 - Contributed Session How to analyse an adaptive trial: tests, estimates Frailty models Repeated measurements (Part I) Genetics and confidence intervals Chair: Chair: Chair: Chair: Peter Bauer (Austria) David Oakes (USA): On Risk Reversal Due to Stephen Vander Hoorn (New Zealand): Rethinking Thomas Hielscher (Germany): On the prognostic 09:00 - 09:30 Heterogeneity. the value of correlation between repeated observations value of gene expression signatures for censored data. Werner Brannath (Austria): Liselotte Petersen (Denmark): Shared frailty model when designing randomised clinical trials. Wendimagegn Ghidey (Netherlands): Prediction Estimation after treatment selection in flexible for case-cohort samples: Parent and offspring relations Saskia Litière (Belgium): Diagnostic Tools for Models for SNP Data. designs. in an adoption study. Misspecification in Mixed Models. Keith Humphreys (Sweden): Pathway based 09:30 - 10:00 Goele Massonnet (Belgium): Using copulas to model Ian White (UK): When is multiple imputation better approaches for genetic association analysis. four-dimensional udder infection data. than complete cases analysis for handling missing Carl-Fredrik Burman (Sweden): Bettina Kulle Andreassen (Norway): Accounting for Karla Hemming (UK): Sensitivity models for covariates? haplotype phase uncertainty in linkage disequilibrium Statistical philosophy and the analysis of flexible missing covariates in the analysis of hierarchical Shaun Seaman (UK): Doubly Robust Generalised estimation. trials. survival data. Estimating Equations for Longitudinal Data. Andrea S. Foulkes (USA): Haplotype-trait 10:00 - 10:30 Yongling Xiao (Canada): Bootstrap- vs. frailty- based Alain Le Tertre (France): Meta-analysis of multiple association analysis using mixed modeling. John Whitehead (UK): inference for clustered event times. outcomes in air pollution epidemiology: Multivariate Sequential procedures for discovering genetic vs. multi-univariate approach. associations with adverse drug reactions, and what to do when you find one. 10:30 - 11:00 Refreshments - Poster & Exhibition Viewing 11:00 - 12:00 S26 - Keynote Lecture Chair: Emmanuel Lesaffre (Belgium) Niels Keiding (Denmark): Sampling patterns in event history analysis with applications to epidemiology. “Event history models are now a well-established tool in epidemiology and demography, but the concrete statistical analysis still presents methodological challenges. Main reasons for this are the desire to involve several time origins (calendar time, age and duration) and complex sampling patterns, be it interval censoring or sampling at a cross-section in calendar time. This talk will present a framework for handling these problems in applied event history analysis as well as concrete examples, including design and analysis of time-to pregnancy data as well as follow-up studies of fillings in primary teeth.” 12:00 - 13:00 Annual General Meeting 13:00 - 14:00 Lunch - Poster & Exhibition Viewing

ISCB News #45 Page 22 June 2008

ISCB 29 Copenhagen 2008: Draft Programme 29th Annual Conference of the International Society for Clinical Biostatistics Copenhagen, Denmark 17-21 August 2008 www.iscb2008.info WEDNESDAY, 20 AUGUST 2008 14:00 - 15:30 CS27 - Contributed Session CS28 - Contributed Session CS29 - Contributed Session CS30 - Contributed Session Statistical methods Non-randomised studies Sequential and adaptive studies (Part II) Meta-analysis (Part II) Chair: Chair: Chair: Chair: Ian James (Australia): Statistical issues in large-scale Saskia le Cessie (Netherlands): Combining matched Anne Whitehead (UK): Interim Analyses of Long- Theo Stijnen (Netherlands): Random effect meta- viral-host genetic association studies. and unmatched control groups in case-control studies. term Ordinal Outcomes: Use of Short-term Data. analysis with rare events. Janne Petersen (Denmark): Three Step Latent Class Gerard Van Breukelen (Netherlands): ANCOVA Heiko Goette (Germany): Adaptive Designs with Kristian Thorlund (Denmark): Incorporating Analyses. versus Change from Baseline in Nonrandomized Correlated Test Statistics. uncertainty of between-trial variance estimates Aihua Liu (Canada): Testing interaction with Studies. Bjorn Winkens (Netherlands): Adaptive versus increases the reliability of random-effects meta- aggregate index of multi-dimensional exposure. Stephen Senn (UK): Fair Comparisons of Mini- Robust Designs for Repeated Measures Experiments. analysis. Patrick Royston (UK): Investigating Interactions in misation and Atkinson’s Algorithm. Mounia Hocine (UK): An adaptive case series SPRT Milena Castro (UK): Bayesian mixed comparison Multivariable Model-building with Continuous Micha Mandel (Israel): Estimating the Probability of for prospective surveillance of vaccine safety. meta-analysis of interventions for metabolic syndrome. Covariates. Infection Under Cross-Sectional Sampling. Verena Roloff (Germany): A Bayesian perspective on Félix Almendra-Arao (Mexico) (Scientist Award Michal Abrahamowicz (Canada): Could Interactions design modifications of a group sequential trial. Sofia Dias (UK): Checking consistency of direct and Winner): Comparison of Significance Levels for the Help Investigate Unobserved Confounding? indirect evidence in Mixed Treatment Comparison Farrington-Manning Test. Meta-analysis. Marta Fiocco (Netherlands): Semi–Parametric Models for Meta-Analysis of Survival Curves in case of Heterogeneity. 15:30 - 16:00 Refreshments - Poster & Exhibition Viewing 16:00 - 17:30 CS31 - Contributed Session CS32 - Contributed Session CS33 - Contributed Session CS34 - Contributed Session Models in survival data (Part II) Clinical trials (Part II) Biomarkers (Part II) Repeated measurements (Part II) Chair: Chair: Chair: Chair: Mei-Ling Ting Lee (USA): A Threshold Regression Jen-pei Liu (Taiwan): Inference on Treatment Effects Oke Gerke (Denmark): ET/CT in cancer: On the Michael Haber (USA): Evaluation of Individual Mixture Model for Assessing Treatment Efficacy in for Targeted Clinical Trials under Enrichment planning of diagnostic phase II studies. Observer Agreement from Data with Repeated Clinical Trials. Designs. Marinus Eijkemans (Netherlands): Combining Measurements. Jan Beyersmann (Germany): Time-dependent Steven Teerenstra (Netherlands): Sample size Bayesian Multiple Imputation of Below-Detection- Patricia Martinkova (Czech Republic): Reliability of Covariates in the Proportional Subdistribution planning of a cluster randomized trial with three Limit Missing Data, with Classical Analysis. composite dichotomous measurements. Hazards Model. levels. Federico M. Stefanini (Italy): Conditional Chris Metcalfe (UK): Reference ranges for Nadine Grambauer (Germany) (Student Award Bruno Pereira (France): Effect of sample size independence relationships among conventional monitoring men with early stage prostate cancer. Winner): Proportional subdistribution hazards estimation on the analysis of cluster randomised trials. biomarkers in breast cancer. Arne Ring (Germany): Statistical Models for the modeling offers a summary analysis, even if mis- Stephen Walters (UK): Models for analysing data Yuan-Chin I. Chang (Taiwan): Sequentially Heart Rate Correction of the QT Interval. specified. from individually randomised trials with clustering by determine the optimal case-control ratio for estimating Alexander de Leon (Canada): Estimation of Larry Ma (USA) (Student Award Winner): A new health professional. the classification accuracy of a biomarker. diagnostic accuracy measures for a binocular test. partial likelihood for the Cox proportional hazards Ruediger P. Laubender (Germany): Estimating Nadege Dossat (France): Bivariate normal mixtures model. adjusted Number Needed to Treat (NNT) Measures applied to the biomarker identification for SELDI- Qing Wang (UK): Assessment of survival benefit for Survival Data with bootstrapped Confidence TOF mass spectra data. after lung transplantation. Intervals. 19:30 - Conference Dinner: Restaurant Påfuglen

ISCB News #45 Page 23 June 2008

ISCB 29 Copenhagen 2008: Draft Programme 29th Annual Conference of the International Society for Clinical Biostatistics Copenhagen, Denmark 17-21 August 2008 www.iscb2008.info THURSDAY, 21 AUGUST 2008 08:00 - 12:30 Registration Conference venue: H. Lundbeck A/S Statens Serum Institut Time The School of Architecture Ottiliavej 9, Valby Artillerivej 5, Copenhagen 09:00 - 10:45 MS01 - Mini Symposium MS02 - Mini Symposium MS03 - Mini Symposium Recent developments in survival data Design of phase I and II studies Statistics in vaccines research

Part I - Recurrent events Part I - Phase I studies: dose escalation Part I – Vaccine safety Chair Mei-Ling Ting Lee (USA) Chair: Simon Day (UK) Chair: To be determined 09:00 - 09:35 09:00 - 09:35 09:00 - 09:35 Intensity-based models for recurrent events Dose-finding in first-in man studies in healthy volunteers Real-time vaccine safety surveillance for the early detection of Per Kragh Andersen (Denmark) Stephen Senn (UK) adverse events 09:35 - 10:10 09:35 - 10:10 Martin Kulldorff (USA) Estimation of marginal features of recurrent event processes under First-in man studies: what role do statistics and statisticians play? 09:35 - 10:10 event-dependent censoring Deborah Ashby (UK) Richard Cook (Canada) Establish the safety of Rotarix following the withdrawal of Part II - Phase II studies: proof of concept RotaShield Part II - Considering survival times as first hitting times 10:10 - 10:45 Francois Beckers (Belgium) 10:10 - 10:45 Design issues for proof-of-concept studies 10:10 - 10:45 Andy Grieve (UK) What hides behind the data? Statistical issue in evaluating safety on vaccine product –

Odd Aalen (Norway) perspective from an FDA statistician Jingyee Kou (USA)

10:45 - 11:15 Refreshments Refreshments Refreshments 11:15 – 13:00 MS01 - Mini Symposium (Cont.) MS02 - Mini Symposium (Cont.) MS03 - Mini Symposium (Cont.) Recent Development in survival data Design of phase I and II studies Statistics in vaccines research

Part III - Register-based studies 11:15 - 11:50 Part II – Correlates of protection Chair Saskia Le Cessie (The Netherlands) Chair Carl-Fredrik Burman (Sweden) Chair: To be determined 11:15 - 11:50 Proof of concept: the translational step from drug discovery to the 11:15 - 12:00 Title to be determined clinic Assessing an immunological surrogate endpoint in vaccine trials Preben Bo Mortensen (Denmark) Michael Branson (Switzerland) 11:50 - 12:25 Li Qin (USA)

Timing and duration of familial breast cancer risk, using population 12:00 – 12:45 register data Part III - Phase II studies: Dose-finding. Choosing Correlates of protection: Advances and challenges Marie Reilly (Sweden) doses before as well as after the study 12:25 - 13:00 11:50 - 12:25 Andrew Dunning (USA) Sensible uses of linked registry data when either outcome or Optimal designs for dose-finding studies exposure data are missing Frank Bretz (Switzerland) Bianca de Stavola (UK) 12:25 - 13:00 Dose-response - an estimation problem Anders Kallen (Sweden)

ISCB News #45 Page 24 June 2008

ISCB 29 Copenhagen 2008: Draft Programme 29th Annual Conference of the International Society for Clinical Biostatistics Copenhagen, Denmark 17-21 August 2008 www.iscb2008.info Mon 18 – Tue 19 August 2008 Posters I Lee, Juneyoung (South Korea) A meta-analysis of RCTS for efficacy and gastrointestinal safety of Celecoxib versus other NSAIDs Author: Title: Lu, Guobing (UK) Evidence-Consistency Modelling for Mixed Treatment Comparisons Meta-analysis Adrion, Christine (Germany) Bayesian model diagnosis and model validation for longitudinal count data Magyar, Gabriella (Hungary) Performance of inter-subject CV% calculations - A simulation study Anisimov, Vladimir (UK) Impact of Patient Recruitment and Randomization on the Design of Multicentre Clinical Trials (Scientist Award Winner) Arends, Lidia (Netherlands) Summary ROC curves in meta-analysis of diagnostic data: Does it make sense? Maracy, Mohammad (Iran) The duel factor structure of the Mood Disorder Questionnaire in rural Iranian pregnant women Benavente, Yolanda (Spain) Evaluation of the minimum sample size for detecting SNPs interactions with classification tree Martens, Edwin (Netherlands) The use of the overlapping coefficient in minimization procedures models in case-control studies Mazumdar, Sati (USA) Noninferiority Trials in Mental Health Service Research Bogaerts, Jan (Belgium) Evaluating a 70-gene signature in early breast cancer: Methodology and results Newcombe, Robert (UK) Confidence interval location Cai, Zhihong (Japan) Bounding methods for evaluating the performance of medical diagnostic tests Noergaard Moeller, Lisbeth Methods for finding relevant causal effects Candel, Math (Netherlands) The Relative Efficiency of Equal versus Unequal Group Sizes for Trials comparing Group to (Denmark) Individual Treatments Ofner-Kopeinig, Petra (Austria) Comparing permuted block randomization to other randomization methods: An example Chankaramangalam Mathew, Anil Applications of repeated measurement analysis in the study on efficacy of Levocetrizine, (India) Desloratidine and Fexofenadine in histamine induced wheal suppression. Omar, Rumana (UK) A multivariate multilevel model for the analysis of a longitudinal study on chronic pain Cho, Meehye (South Korea) Correct Use of Standard versus Repeated Measures Analysis of Variance Omata, Kazumi (Japan) Spatiotemporal analysis of influenza epidemics in Japan Cortiñas Abrahantes, José (Belgium) Alternative Methods to Evaluate Trial Level Surrogacy Park, Eunsik (South Korea) Covariate-adjusted response-adaptive designs for longitudinal treatment responses Dwivedi, Alok Kumar (India) A Comparison of Some Count Models for Describing the Axillary Lymph Nodes Involvement in Pennells, Lisa (UK) Assessing prognostic models in individual participant data meta-analysis; Quantifying the added Breast Cancer Patients value of measuring a new risk factor Faldum, Andreas (Germany) Strategies to Include Interim Patients - KRANIOPHARYNGEOM 2007 Trial Procter, Marion (UK) Left Ventricular Ejection Fraction as a Measure of Cardiac Function in the Herceptin Adjuvant (HERA) Trial Finos, Livio (Italy) Accelerated Case-Control Study Ramsay, Timothy (Canada) Conditional bias in trials stopped early for benefit Foulkes, Andrea S. (USA) Prediction based classification for longitudinal biomarkers with application to HIV disease monitoring in resource-poor settings. Robaina Garcia, Maytee (Cuba) Analysis of incomplete longitudinal psychiatric data Galimberti, Stefania (Italy) Sample size for recurrent events data in non randomized studies with an historical control Salahuddin (Pakistan) Statistical Study of the Socio-economic factors of Tuberculosis in Kohat District (Pakistan) Gaur, L.N. (India) Consequences of Unmatched analysis of Matched Data in a Case-control study. Simpson, Annie (USA) Estimating Long-term Placebo Effect using Short-term Repeated Measures Data and Meta Analysis Gonzalez, Carmen E.V. (Cuba) Meta-analysis for global safety evaluation of EGF human recombinant vaccine in patients with advanced lung cancer Sooriyarachchi, Roshini (Sri Lanka) Analysis of a Clinical Trial with Single and Multiple Dose Treatments (Scientist Award Winner) Gonçalves, Luzia (Portugal) Sample Size for Estimating a Binomial Proportion: Comparison of Different Methods Sugano, Hiromi (Japan) Case-control study to investigate a relationship between hormone replacement therapy (HRT) Guo, Xiuhua (China) Study on Enhancement of CT Images over Peripheral Small Lung Carcinomas Via Wavelet and breast cancer in Japan: Including further statistical approach Transform and Other Pretreatment Methods Szafraniec, Krystyna (Poland) Acute health effects of particulate matter pollution in population of Krakow, Poland. Hernandez-Boussard, Tina (USA) Signal detection: A statistical method to predict post-gastric bypass weight loss (Scientist Award Winner) Hosseini, Sayed Mohsen (Iran) Risk Scoring System For prediction of Abdominal Obesity in an Iranian population of Youths: Thalabard, Jean-Christophe (France) HIV incidence estimation from repeated cross-sectional surveys: A comparative study of CASPIAN Study parametric and nonparametric approaches by simulation Hosseini, Mostafa (Iran) Identification of predictors of recurrence of generalized pustular psoriasis, Tehran, Iran; 1990 - Tilley, Barbara (USA) Randomized Trial of Pharmacy Interventions to Improve Chronic Disease Medication Refill 2007 Adherence Jiang, Yannan (New Zealand) Case-control analysis with a continuous outcome variable Vander Hoorn, Stephen (New RIOT: A research impact and outcomes assessment tool Jovic, Gordana (Italy) Exact and approximate methods for design of single-stage and two-stage phase II cancer clinical Zealand) trial Vernic, Corina V. (Romania) Evolution of epidemic models Kada, Akiko (Japan) Diagnostic accuracy based on counterfactual interpretation Walters, Stephen (UK) Models for analysing data from cluster randomised trials Katina, Stanislav (Slovak Republic) Matched-pair shape coordinate data and detection of shape outliers Wang, Xikui (Canada) Statistical inference of response adaptive clinical trials Kavanagh, Kimberley (UK) Statistical methods for the investigation of the effects of deprivation on spatial clustering in Whegang, Solange (Cameroon) Modelling repeated measurements from patient with uncomplicated plasmodium falciparum report of influenza-like illness malaria Kuroki, Manabu (Japan) Evaluating causal effects in studies with unmeasured confounders and selection bias Wunder, Christina (Germany) Adaptive Designs Accounting for Covariates and Random Loss-to-Follow-Up Laaksonen, Maarit A. (Finland) Estimation of Population Attributable Risk (PAR) in a cohort study design using a piecewise exponential model

ISCB News #45 Page 25 June 2008

ISCB 29 Copenhagen 2008: Draft Programme 29th Annual Conference of the International Society for Clinical Biostatistics Copenhagen, Denmark 17-21 August 2008 www.iscb2008.info Wed 20 - Thu 21August Posters II Mohammadi, Leila (Netherlands) A simple method for co-segregation analysis to evaluate the pathogenicity of DNA variants of unknown significance in BRCA1 and BRCA2 Author: Title: Mullee, Mark (UK) Web-based resources to assist the statistical analysis and presentation of data Akyol, Mesut (Turkey) Milk Consumption Habits in Turkish Society and Milk Knowledge Point Parrinello, Giovanni (Italy) Flexibility in multi-state model: AIDS related and no AIDS related mortality in HIV patients Allardice, Gwen (UK) Survival analyses of time to cancer in persons with HIV in Scotland Parrinello, Giovanni (Italy) Retinopathy in type 2 Diabetes: Competing Risk Analysis with joint model of longitudinal data Amado, Conceição (Portugal) Multiple tests for robust regression in microarray data and accelerated failure time models Ambrosi, Alessandro (Italy) Hot and Cold. Statistical Strategies to Identify High and Low Integration Density Areas Over the Pezeshk, Hamid (Iran) A Cost-Benefit Approach to Sample Size Determination for Trials with Binary Responses Genome in Gene Therapy Settings. Pfirrmann, Markus (Germany) Conditional logistic regression applied to matched clinical trial data from patients with chronic Andersen, Jens S. (Denmark) Combined symptom and medication score in immunotherapy clinical trials myeloid leukemia Banu, Eugeniu (Romania) Proposal for a new approach in time-to-event univariate analysis. Postelnicu, Tiberiu (Romania) Bayesian Methods for Clinical Trials Benavente, Yolanda (Spain) Polymorphisms in apoptotis and immunoregulatory related genes are associated with an Prieto-Merino, David (UK) Different groupings of Drug Adverse Events in a Bayesian Analyses. increased risk of chronic lymphocytic leukemia Rebora, Paola (Italy) Analysis of recurrent complications with intermittent exposure and time-varying treatment in Benedetti, Andrea (Canada) Challenges in estimating recent transmission of tuberculosis cancer Biganzoli, Elia Mario (Italy) Breast cancer recurrence according to different body sites. Non parametric estimates and flexible Reiczigel, Jenö (Hungary) Credible bands for curves estimated from Bayesian models hazard regression models for competing risks in breast cancer recurrence dynamics Ring, Arne (Germany) Outliers in Bioequivalence Studies with Replicate Design Braga, Ana Cristina (Portugal) A new tool to help diagnostic performance analysis - ROCNPA Sanisoglu, S. Yavuz (Turkey) Data Mining Implementation in The Ministry of Health Celen, Özay (Turkey) Analysis of Factors Affecting Productivity of Physicians Working at Turkish Armed Forces Military Hospitals Siever, Jodi (Canada) Homogeneity, Sample Size, and Accuracy: Non-response Bias in a Physician Survey Choodari-Oskooei, Babak (UK) Summarising the Predictive Ability of a Survival Model Silver, Jeremy (Denmark) Power of genome-wide association studies with multiple case subgroups Culliford, David (UK) Regional Variation in Joint Replacement: Disease or Service Provision? Stoevring, Henrik (Denmark) Weibull Survival Analysis with Truncated, Interval Censored Event Data, or with Empirical Survivor Function Data only Dalesio, Otilia (Netherlands) Online Tools to Support Clinical Trials Processes Takahashi, Yoshimitsu (Japan) An annual epidemic of influenza in Japan analyzed with network analysis Demir, Cesim (Turkey) A Turkish Outsourcing Model in The Management of Health Services Tan, Sze-Huey (Singapore) A Case Study Evaluating Vaccine Efficacy using All Events Analysis Denis, Marie (France) Free knot splines with RJMCMC for logistic models and threshlod selection. Teke, Abdulkadir (Turkey) The association of physician characteristics with their atitudes about uncertainty, risk taking and Denis, Enachescu (Romania) Statistical methods for pituitary tumor prediction cost consciousness Dunkler, Daniela (Austria) Weighted Cox regression applied to microarray studies – a critical appraisal Thorlund, Kristian (Denmark) Agreements and disagreements in statistical inferences from random-effects model meta- Elmali, Ferhan (Turkey) Effects of the induction of labor with misoprostol for premature rupture of membranes at term on analyses performed with different between-study variance estimators Apgar Scores and pH value of umbilical arterial blood Tian, Wei (USA) Power Analysis of ANCOVA and Two Non-Parametric Procedures Faltus, Vaclav (Czech Republic) Logistic regression and classification and regression trees (CART) in acute myocardial infarction Uematsu, Yumiko (Japan) Statistical method for evaluating the efficacy of a drug for osteoporosis on the occurrence of data modelling bone fractures Focsa, Mircea (Romania) Prognostic discrimination in Chronic Myeloid Leukaemia Vahabi, Surena (Iran) Clinical versus statistical significance in the Iranian postgraduate periodontal theses. Freitas, Adelaide (Portugal) Difference of Codon Associations between Pantroglodyte and Homosapien Valenta, Zdenek (Czech Republic) Multivariate Analysis of QoL Data in Crohn’s Disease Patients Gao, Fei (Singapore) Kernel smoothing for the detection of peaks in the hazard function Weston, Claire (UK) The Application of Non-Mixture Cure Models in WinBugs where Random Effects are of Interest Gleiss, Andreas (Austria) Robust Identification of Differentially Expressed Genes by Adaptive Trimming Yamaoka, Kazue (Japan) Evaluation of cross-cultural equivalence of QOL measures in clinical trials settings: A mixture Guo, Xiuhua (China) Ways of transportation to work involve dyslipidemia in Beijing workers model Hajian-Tilaki, Karimollah (Iran) Association of parity and live birth with risk of obesity in women Yildirim, Yasar (Turkey) Measurement Efficiency of Used Inactive Medical Equipment Efficiency of Tobit Modelling On Hoffmann, Verena (Germany) Reporting of Censoring in Randomised Clinical Trial Publications Hospital Karadag, Mevlut (Turkey) The Probable Problems on Homecare Services: Turkish Armed Forces Academic Physicians’ Ziegler, Andreas (Germany) Evidence Based Reporting of Genetic Epidemiological Studies Opinions Zwinderman, Aeilko (Netherlands) Penalized Canonical Correlation Analysis for Completing Molecular Genetic Pathways Lauseker, Michael (Germany) Turnbull’s nonparametric estimator for interval-censored data in the case of informative van Putten, Wim (Netherlands) A closer look at the role of complex cytogenetic abnormalities in AML as an indicator of poor censoring – a simulation study prognosis. Leissen, Sandra (Germany) Nonparametric Trend Tests for Right-Censored Survival Times McKinnon, Elizabeth (Australia) A survival-based pairwise measure of SNP-disease association

ISCB News #45 Page 26 June 2008

Formation of a New Subcommittee on Vaccines

From Andrew Dunning At ISCB28 in Alexandropoulos last August, after a session on the It is hoped the committee will act as a focal point for statisticians statistics of vaccines research, some vaccines statisticians were worldwide working in vaccines research. discussing the presentations, and realized they had been working A mini-symposium on Statistics in Vaccines Research is being on similar problems and dealing with similar issues for some organized for the Thursday of this year’s conference in Copenhagen . time, without knowing that others were also. The conversation At the time of going to press, the program is was summed up when someone said “I always knew there must be other statisticians working on these questions, and now I've Session 1, 09.00 - 10.45: Vaccine Safety finally found them.” • Martin Kulldorff (Harvard University, USA). Real-Time Vaccine Out of the meeting, an informal email discussion developed – Safety Surveillance for the Early Detection of Adverse Events about twenty-five participants exchanging ideas about how • François Beckers (GlaxoSmithKline, Belgium). Establishing the statisticians working in vaccines research could share their Safety of Rotarix following withdrawal of RotaShield experiences and coordinate their efforts. The decision was • Jingyee Kou (Food and Drug Administration, USA). Statistical reached to ask the ISCB to form a Vaccines sub-committee that issue in evaluating safety of vaccine product - perspective from would include representatives from academia, industry and an FDA statistician. regulatory agencies, and from North America and Europe. The initial members of the committee are: • Open Discussion Andrew Dunning (USA) andrew.dunning@ Session 2, 11.15 - 13.00: Correlates of Protection sanofipasteur.com • Li Qin (University of Washington, USA). Assessing an Paddy Farrington (UK) c.p.farrington@ immunological surrogate endpoint in vaccine trials open.ac.uk • Andrew Dunning (Sanofi Pasteur, USA). Correlates of Lawrence Moulton (USA) lmoulton@ jhsph.edu Protection: Advances and Challenges Marc Fourneau (B) marc.fourneau@ gskbio.com • Open Discussion Allen Izu (USA) izu@ novartis.com The sub-committee has also established a mailing list of statisticians Jos Nauta (NL) jos.nauta@ solvay.com in vaccines research to publicize its activities and disseminate Ivan Chan (USA) ivan_chan@ merck.com information of interest to vaccine statisticians. In addition to Jingyee Kou (USA) jingyee.kou@ fda.hhs.gov promoting the mini-symposium, details of vaccines sessions at other Catherine Quantin (F) catherine.quantin@ chu- statistical conferences will be assembled and shared through the dijon.fr mailing list as they become known. Julia Singer (A) julia_singer@ baxter.com The committee sees an unmet need to provide an improved understanding of the statistics of vaccines research to clinicians and The ISCB Officers approved the proposal in March; confirmation other practitioners, and is developing arrangements to promote by the Annual Meeting will be on the agenda at ISCB29 in statistical speakers at non-statistical vaccines conferences. In a Copenhagen in August. further initiative, the sub-committee is exploring a possible role of The terms of reference of the sub-committee are to dissemination of recent vaccines statistical research through its 1. Create a professional platform for statisticians active in mailing list. the research on vaccines To add your name to the mailing list, send an email to 2. Discuss new regulatory guidelines and comment upon Jos.Nauta@ solvay.com, who is coordinating the list on behalf of the draft guidelines, in collaboration with the committee. subcommittee on Statistics in Regulatory Affairs The sub-committee would also be pleased to hear ideas and 3. Keep up-to-date, discuss, apply and encourage relevant suggestions on any aspect of vaccines statistics which they might statistical and methodological developments take an interest in or act upon, or from any statisticians who would 4. Encourage professional development like to volunteer to assist with its activities. Contact Jos Nauta (above) or Andrew Dunning, the sub-committee chair 5. Organize symposia in the annual ISCB meetings or in (andrew.dunning@ sanofipasteur.com). collaboration with ISCB on methodological developments in vaccines research

Polish National Group: Update

From Ewa Kawalec will take place in Warsaw 19-21 of June 2008, the Activities of the Polish National Group of ISCB special session organized by the Polish National Group (December 2007-May 2008) entitled ‘Statistical standards in medical research The Polish National Group of ISCB consists now of 58 projects and publications’ will be addressed to medical members. doctors. Beyond this, in June MSOURCE Medical Development in cooperation with our Group will At the scientific meeting in December 2007, our organize a two-day course on ‘Survival analysis’ with members gave six lectures on different topics Thorsten Reineke and Tomasz Burzykowski as lecturers. (bootstrap methods, sequential estimation, classification methods). The new homepage of our Group (www.iscb.pl in Polish) introduces our Group to Polish statisticians and others The next scientific meeting is scheduled for June who are interested in application statistics to medical 2008 in Warsaw. During the Seventh International research. Seminar on ‘Statistics and Clinical Practice,’ which

ISCB News #45 Page 27 June 2008

Book Review by Denis Enachescu (Romania)

John Aitchison, Jim W. Kay and Ian J. Statistical Concepts and Applications in Clinical Chapman & Hall/CRC (2005) Lauder Medicine 1-58488-208-5

This book, published in the Chapman & The unifying statistical methodology used by the Hall/CRC Series in Interdisciplinary Statistics, authors is the modelling and fitting of p uv , the is an interesting problem-oriented approach to S ( ) using statistical methods in clinical medical conditional distribution of a typical selected case S practice through each stage of clinical process: using the data set Duvin=={( ii,:1,.,) } of the observation, diagnosis and treatment. Aimed at a level of readership ranging from advanced selected cases SS1,., n and assuming that the undergraduate, through postgraduate to clinician has identified in u and v all that is possibly consultant statistician and researcher worker, relevant to the referred patient’s problem. This the book is in its outlook a suitable basis for a framework take the reader into the area of course of data analysis. hypothesis testing, the regression analysis when the The Contents is the following: 1. The Field of response vector is compositional in nature, the Application; 2. Relating the Present Patient to Gibbs sampling, biplots as a useful summary of the Past Experience; 3. A Review of Statistical multivariate data and kernel methods for the non- Methodology; 4. Further Statistical parametric modelling. Methodology; 5. Experience; 6. Observation and Most book on medical statistics confine attention to Measurement; 7. Indirect Measurement: Assay the types of statistical problem arising in medical and Calibration; 8. Diagnosis; 9. Special research. A much more extension view of medicine Aspects of Diagnosis; 10. Prognosis and is taken in this book, including the actual practice Treatment; 11. Assessment. An overview of the of medicine as well as medical research. medical applications discussed in the book is In the true spirit of applied mathematics, this book given in Appendix A. There are 25 problems takes as its starting point the particular field of with data sets which have been analyzed application with the consequence that its provide a beginning with the determination of natural and unified development as they relate to concentration of aldosterone in blood samples the medical application. and ending with the observer error in studies There is no pre-alignment with any particular involving diagnoses made on the basis of large ideology of statistical inference such as Bayesian, and small X-rays passing through bilateral frequentist or structuralist; each practical problem hyperplasia, cervical cancer, Conn’s syndrome, is examined on its own merits. haemophilia, Kerato-conjuctivitis sicca, etc. The The authors provide clear, accessible explanations of last but not the least the data sets are available statistical methods and include end-of-chapter from the book web-site as well as S/R scripts exercises that help develop formulatory, analytic and and WinBUGS programmes used to perform interpretative skills. almost all of the work. In conclusion, this text presents an insight into the consultant statistician/clinician interaction and provides a good guideline on the different uses of statistical methods in clinical medical practice for the novice and experienced user alike.

ISCB News #45 Page 28 June 2008

Czech National Group: Update

From Zdenek Valenta

On 11 September 2008, the Czech National Group of At the end of March 2008 the Group welcomed a the ISCB will celebrate two years of its official distinguished speaker, Ladislav Tomášek from the existence. It was founded as a fourth official national National Radiation Protection Institute in Prague 4 - group of the Society, following an example of Poland, Nusle, with his invited talk entitled “The Risk of Lung Hungary and Romania. To date, the Group totals Cancer Incidence in Relation to Radon Exposure and about thirty registered members, two of whom come Smoking – a Nested Case-Control Study”. This lecture from neighbouring Slovakia. The principal activity of too has been video-recorded and made available online our group continues to dwell in organizing scientific to all members of the National Group along with the seminars, in which invited speakers, typically slides used in the lecture. outstanding researchers and scientists from the field Members of the Local Organizing Committee of ISCB30, of biostatistics, discuss methodological aspects of who are all members of the Czech National Group of analyzing medical data and share their expertise and ISCB, have continued the preparatory works for the hands-on experience from the field of collaborative 2009 anniversary event, which is going to take place in interdisciplinary research related to medicine. Prague, Czech Republic, between 23 and 27 August. The In October last year the members of Czech National Group is closely cooperating with the conference Group welcomed Stanislav Katina from the organising agency Guarant International, Ltd. Department of Applied Mathematics and Statistics, (www.guarant.cz). The Conference will be held in the Comenius University in Bratislava, Slovakia, who new premises of the University of Economics in Prague. also holds a secondary appointment at the The Scientific Programme Committee of ISCB30 has Department of Anthropology, Faculty of Life Sciences begun its work under the leadership of Geert at the University of Vienna, Austria. He presented his Molenberghs, who currently serves as a director of the talk entitled “Geometrical aspects of statistical shape International Institute for Biostatistics and Statistical analysis and their interpretations with applications Bioinformatics, which is a joint initiative of Leuven and in biology”, which featured novel statistical Hasselt Universities in Belgium. He also serves as a vice- technologies related to analysis of shape. His talk director of the Centre for Statistics at Hasselt University, was video-recorded and all the materials including Belgium. Much of the scientific content of the the talk slides were made available to all Group Conference has already begun to take shape, including members for further reference. the pre-conference courses and invited sessions. More details are available in the ISCB30 report section of the Newsletter.

ISCB30: Prague, Czech Republic: Update

From Zdenek Valenta

This year, the Local Organising Committee (LOC) of the 2009 Apart from the conventional interest in the design and conference of the International Society for Clinical analysis of data from clinical and epidemiological studies, a Biostatistics (ISCB, “Society”) commenced a second year of fresh emphasis of the Conference will be put on “Health preparatory arrangements for the 2009 annual event. Next Economics Evaluation”, which will be a hot topic of the 2009 year the Society will convene its 30th annual conference event. This subject continues to draw a lot of interest on (“Conference”), thereby reaching a significant milestone in its international and particularly European health policy level, history. This important event will take place on the campus of and the invited opening plenary session will be devoted to this the University of Economics in Prague, Czech Republic, subject. Another vibrant component of the Conference will be between 23 and 27 August 2009. The Conference is jointly Thursday’s symposium on Biomedical Informatics, which is organised by the Czech National Group of the ISCB, Institute expected to draw a lot of interest from the rapidly growing of Computer Science of the Academy of Sciences of the Czech community interested in biomedical research. Other invited Republic, and European Centre for Medical Informatics, sessions will include “Joint Modelling of Longitudinal and Statistics and Epidemiology (EuroMISE Centre) in Prague. Survival Data”, “Regulatory Affairs”, “Incomplete Data” as well The appointed chair of the Scientific Programme Committee as “Multi-country trials in HIV prevention and treatment”. (SPC) for the Prague event is Geert Molenberghs, who The University of Economics in Prague, the Conference venue, currently serves as a director of the International Institute for is located near the historic city centre, with an easy and Biostatistics and Statistical Bioinformatics, which is a joint convenient access to all by means of Prague public initiative of the Leuven University and Hasselt University in transportation, which will safely bring you to virtually any Belgium. He continues to serve as a vice-director of the attractive Prague’s destination of your choice. A number of Centre for Statistics at Hasselt University, Belgium. With his trips and tours to various historic sites and places of interest experienced scientific leadership the organisers are very are being planned for the participants of the ISCB30 as part excited and highly confident of an excellent scientific content of the social programme. They will include visits to medieval of the Conference that should draw considerable interest from castles in Prague’s vicinity (e.g. Karlštejn castle, Křivoklát a large community of biostatisticians and medical researchers castle), a visit to famous Pilsner Brewery, a trip to historic spa from the field of clinical trials from around the globe. city of Karlovy Vary (Carlsbad) and other appealing options. The President’s invited speaker for the occasion of convening The conference dinner will be served in the historic premises the Society’s 30th annual conference will be Marc Buyse from of Keiserštejn’s palace located in Prague‘s Lesser Town, which Belgium. He will address the audience with his talk entitled will be a great location for the purpose of celebrating the “On Trial Endpoints that Combine Clinical Relevance and Society’s 30th anniversary in Prague. Statistical Efficiency”, which will include discussion of recent It will be my deep pleasure meeting you in Prague in 2009 at methodological advances in analyzing complex clinical trials the occasion of convening the 30th annual conference of the endpoints. ISCB.

ISCB News #45 Page 29 June 2008

Book Review by Sada Nand Dwivedi (India)

R. A. Maronna, R. D. Martin and V. J. Yohai Robust Statistics: Theory and Methods Wiley (2006) 0-470-01092-4 In the last four decades the field of robust statistics has model assumptions. Outlier detection methods are amply experienced substantial growth as a research area, as discussed in many textbooks on classical statistical methods, evidenced by a large number of published articles. These and available in several software packages. Further, several methods are considered a powerful tool to increase the commercial statistical software packages currently offer some reliability and accuracy of statistical modeling and data robust methods, with that of the robust library in S-PLUS analysis. Out of several existing robust methods for a model, being the currently most complete and user friendly. In spite of each of which has several variants, major concern of an the increased awareness of the impact outliers can have on applied statistician must be to choose more appropriate from classical statistical methods and the availability of some them. For this, it is important to understand how the robust commercial software, robust methods remain largely unused methods work, and their pros and cons. The present book and even unknown by most communities of applied aims at enabling the reader to select and use the most statisticians, data analysts, and scientists. This book is an adequate robust method for each model. The authors have also effort to overcome this situation. tried to let the reader understand the theory behind the The present book aims at deriving the robust approach to method. The applicability of the robust methods proposed by statistical modeling and data analysis methods that produce many researchers are made possible by the increased speed reliable parameter estimates and associated tests and and accessibility of computers. In summary, for each of the confidence intervals, not only when the data follow a given models covered in this book, they have provided conceptual distribution exactly, but also when this happens only and statistical theory explanations of the main issues; the approximately. While the emphasis of this book is on leading methods proposed to date and their motivations; a approximately normal distributions, the approach works as comparison of the properties of the methods; computational well for other distributions that are close to a nominal model, algorithms, and S-PLUS implementations of the different e.g., approximate gamma distributions for asymmetric data. approaches; and recommendations of preferred robust Further, the data-oriented exploration of robust methods methods. Instead they concentrate on the methods they reveals that they fit the bulk of the data well. To be more consider most sound according to their knowledge and vast specific, if the data contain no outliers the robust method gives experience. approximately the same results as the classical method. Also, One can find the first chapter as a data-oriented motivation if a small proportion of outliers are present, the robust method chapter. The second chapter introduces the main methods in gives approximately the same results as the classical method the context of location and scale estimation that plays major applied to the “typical” data. As a consequence of fitting the role through out the book. The methods for the evaluation of bulk of the data well, robust methods provide a very reliable the robustness of model parameter estimates, and also method of detecting outliers, even in high-dimensional derivation of “optimal” estimates based on robustness criteria multivariate situations. are discussed in third chapter. Chapter four deals with linear The main part of each chapter explains the models to be regression for the case where the predictors contain no tackled and the robust methods to be used, comparing their outliers, typically because they are fixed nonrandom values, advantages and shortcomings through examples and avoiding including for example fixed balanced designs. On the other technicalities as much as possible. This book may be used by hand, fifth chapter deals linear regression with general random both teachers as well as students who are interested in the predictors which mainly contain outliers in the form of so- field of robust statistics. The application oriented readers called “leverage” points. Further, chapter six deals with robust should read enough of each chapter to understand the estimation of multivariate location and dispersion, and robust currently preferred methods with reasons. On the other hand, principal components. In addition, chapter seven deals with the theoretically oriented readers can find proofs and other logistic regression and generalized linear models where as mathematical details in appendices and also in Chapters 9 & chapter eight deals with robust estimation of time series 10. However, general prerequisites are basic courses in models. The ninth chapter illustrates the iterative algorithms probability, calculus and linear algebra, statistics and for the numerical computation of M-estimates. As a matter of familiarity with linear regression. Further, previous knowledge fact, tenth chapter describes the asymptotic theory of some of multivariate analysis, generalized linear models and time robust estimates, and contains proofs of several results stated series is required for Chapters 6, 7 and 8, respectively. in the text. Interestingly eleventh chapter provides detailed As obvious, since the behaviour of a robust procedure may instruction on the use of robust procedures written in S-PLUS. depend crucially on the algorithm used, the book devotes Further, twelfth chapter is an appendix containing considerable attention to algorithmic details for all the descriptions of most data sets used in the book. All methods methods proposed. At the same time, in order that robust are introduced with the help of examples with real data. The statistics is widely accepted by a wide range of users, the problems listed at the end of each chapter consist of both methods need to be readily available in commercial software. theoretical derivations and analysis of other real data sets. Robust methods have been implemented in several available The authors have logically argued in favour of the use of commercial statistical packages, including S-PLUS and SAS. In robust methods. They have expressed that the resulting formal addition, many robust procedures have been implemented in models under classical approaches are simplifications of reality the public-domain language R, which is similar to S. and that their validity is at best approximate. For example, References for free software for robust methods are given at the regarding the most widely used assumption that the observed end of eleventh chapter. However, the authors have focused data have a normal distribution, that has been the framework mainly on S-PLUS because it offers the widest range of for almost all the classical methods in regression, analysis of methods, and because the methods are accessible from a user- variance and multivariate analysis, they opine that there have friendly menu and dialog user interface as well as from the been attempts to justify the assumption of normality with command line. For each method included in the book, theoretical arguments, such as the central limit theorem. instructions are given in eleventh chapter on how to compute Further, a great advantage of classical methods is that they it using S-PLUS. Interestingly, for each example, the book gives require only computational procedures based on well- the reference to the respective data set and the S-PLUS code established numerical linear algebra methods which are that allow the reader to reproduce the example. The book’s generally quite fast algorithms. On the other hand, computing Web site http://www.wiley.com/go/robust_statistics contains robust estimates requires solving highly nonlinear optimization datasets and related codes. On this website, the authors have problems that typically involve a dramatic increase in also incorporated corrections to any errata they subsequently computational complexity and running time. However, discover. Further, to download and install the time-limited fortunately, computers continue getting faster, and have larger version of S-PLUS software, one may follow the instructions at memory, which is good for the future of robust statistics. http://www.insightful.com/support/splusbooks/robstats To Throughout this book, the authors have tried to demonstrate access the web page, in order to activate S-PLUS for Windows, that theoretical and computational convenience does not the reader must use the web registration key that is provided always deliver an adequate tool for the practice of statistics with this book as a sticker on the inside back cover. and data analysis. They have tried to emphasize the dangers posed by atypical data values and of the unreliability of exact

ISCB News #45 Page 30 June 2008

Book Review by Tim Friede (UK)

Tomasz Burzykowski, Geert Molenberghs and The Evaluation of Surrogate Endpoints Springer (2005) 0-387-20277-3 Marc Buyse (Editors)

If a clinical endpoint is rare or requires long follow-up one health, HIV, and oncology. An alternative measure for meta- might be interested in replacing this endpoint by a so-called analytic surrogate evaluation is described in Chapter 18 and surrogate endpoint that is more common or requires shorter a brief discussion of the topic is provided in Chapter 19. follow-up. Starting with Prentice’s seminal paper in 1989 the This book is edited by Tomasz Burzykowski, Geert area of surrogate endpoint validation (or evaluation) has been Molenberghs and Marc Buyse with contributions from subject to intensive research. The book edited by another fourteen authors from academia, industry and Burzykowski, Molenberghs and Buyse captures these regulatory authorities. Early in the book notation and developments. motivating examples are described and the authors are very The book is organised in twenty chapters. Chapters 1 and 2 consistent in their use. Given the relatively large number of explain what surrogate endpoints are and give historical and authors this is an achievement. The high level of consistency regulatory perspectives on the topic. Regulatory issues are is further reflected in an index and a reference list covering dealt with in greater depth in Chapter 3. Here a number of the whole book. This is one book and not a collection of examples are given from the areas of anti-viral drugs, anti- chapters by various authors! cancer drugs and cardiovascular drugs. The following Occasionally the authors provide some information on how chapter introduces notation and motivating examples before the models can be fitted in SAS. More information regarding the historic developments in surrogate endpoint validation implementation in SAS and R can be found at are covered in more detail in Chapter 5. The relatively short www.censtat.uhasselt.be/software/. Chapter 6 extends some surrogate evaluation criteria for the Surrogate endpoint evaluation brings together many situation where data from a single trial are available which interesting areas of statistics including meta-analysis, were introduced in Chapter 5 to different data types. The hierarchical models, longitudinal data analysis and focus of the book is the meta-analytic framework for multivariate time-to-event data models. I enjoyed reading the surrogate evaluation which is introduced in Chapter 7 for book and I certainly learned a lot about these fascinating continuous outcomes and extended in Chapter 9 to allow for areas. The book is suitable as a textbook for a postgraduate more flexibility in the data structure. The choice of units in course in statistics but is also an invaluable reference for the the hierarchical models is discussed in Chapter 8. Chapters applied statisticians working in industry, academia or 10 to 14 describe the meta-analytic framework for other data regulatory authority. types including binary, time-to-event and longitudinal data. References Chapter 15 provides a Bayesian perspective on the topic. Prentice RL (1989) Surrogate endpoints in clinical trials: Chapters 16, 17 and 20 discuss surrogate endpoint Definitions and operational criteria. Statistics in Medicine 8: validation in specific therapeutic areas, namely mental 431-440.

Book Review by Marek Brabec (Czech Republic)

Jayanta K. Ghosh, Mohan Delampady and An Introduction to Bayesian Analysis: Theory Springer (2006) Tapas Samanta and Methods 978-0-387-40084-6

Given the names of the authors (which belong to the gurus of that it is written in a very much self contained style and the Bayesian Statistics), one can expect a priori, that this because it does not presuppose too much of upfront should be a good book, interesting to read. And indeed so, knowledge. The only strong prerequisite is an open and the prior opinion is more than correct! This relatively thin thoughtful mind on the reader’s side (do not expect to read volume is really packed with ideas, examples, thought- this thin book very quickly). On the other hand, level of provoking views and re-views of material from many different exposition is not the same in various chapters. In fact, it areas of Bayesian theory, methods and real-world differs by several orders of magnitude in sophistication (some applications. Unlike in many other recent books on Bayesian but not all of the more advanced material is accompanied theory, there is a lot of beautiful motivation for the concepts with explicit warning). Moreover, at several places, where the and theoretical constructions discussed. That comes in the detailed exposition would be complicated, the reader is form of gradually more and more sophisticated examples, referred to the various original papers and books (the thorough discussion of the underlying ideas (elucidating authors contributed substantially to the bibliography by many of them as very natural formalizations of practical their own work to a large extent). This is very good style for problems). This, together with a vast collection of Exercises instance for a graduate student seeking a thesis topic, or for (collected at the end of each chapter – unfortunately without a person looking for a reference related to a particular topic, keys) constitutes the text as an excellent textbook. It should but it is a bit less satisfactory for a newcomer in the field. be ideal as an additional reading for a graduate level From the ISCB point of view, it is important that this book Bayesian course. Its utility for graduate students and concentrates a lot on several topics very much relevant in everybody who wants to dig a bit deeper into the Bayesian clinical biostatistics. In particular, it devotes a lot of statistical analysis is excellent. In fact, the pedagogical attention to the so called objective priors and their (now quite quality of the text is clearly pronounced in its “multilevel” deep) theory, to Bayesian robustness and to various character. It can be read and utilized substantially by a wide important and interesting practical problems (especially to audience, ranging from a relative newcomer to practitioners those what the authors call high-dimensional problems, in the field who want to deepen their knowledge about including e.g. the microarrays). It contains even an various special aspects of Bayesian approach to Statistics. (information-packed) section on Bayesian computations. This is supported not only by the material covered directly in Taken overall, the book should be recommended to a wide the text but also by the long and very recent list of (partially audience, especially to the ISCB members as a source of commented) references on various hot topics. This book is interesting and mind-provoking information about Bayesian very much accessible to a wide audience – due to the fact Statistics.

ISCB News #45 Page 31 June 2008

Book Review by Gaj Vidmar (Slovenia)

Naomi B. Robbins Creating More Effective Graphs Wiley (2005) 0-471-27402-X

It should be mentioned at the very beginning that this is not a the internet, the vast amounts of freely downloadable statistical book in the strict sense, nor are statisticians its instructions and solutions (sample workbooks, macros and target audience. It can be roughly classified as a book for add-ins) for producing high-quality statistical graphics in general audience using computers to produce graphs based Excel has been almost completely overlooked. I have written a on statistical data, which nowadays stands for literally comprehensive discussion of this issue beyond the scope of millions of people if not more. this review (Vidmar, 2007), so here I just add that while this may well be an unchangeable bias in the world of academic The book has already been reviewed in three relevant journals statistics, it is not a negligible problem for a book with such (Bradstreet, 2007; Bulsara, 2006; Miller, 2007). But the delay general target audience. of this review may actually be beneficial in the sense that a more objective perspective is more easily taken with some Returning to the many positive aspects of the book, a time distance, and that given the pace of developments in particular virtue is the structure that makes it easy to read: information technology, a couple of years can already show all the graphs are on the left-hand side pages, followed by one how well software-related ideas of an author withstand the or two explanatory paragraphs on the neighbouring right- test of time. hand side page. This resembles actual consulting sessions at workshops, which are actually a major part of the author’s The material is organised into ten chapters and two professional activity. Another simple yet effective feature is appendices. A brief Introduction is followed by Limitations of the "not recommended" stop-sign icon on the pages that some common charts and graphs (like pies, 3D effects, bars illustrate bad graphical practice. and bubbles) and some notes on Human perception and our ability to decode graphs (promoting Cleveland’s ordered list of Going back to the book’s deficiencies, a striking one is elementary graphical perception tasks). The preferred graph omission of colour. The word itself is mentioned only three types start with Some more effective graphs in one or two times, while the use of colour in modern data graphics dimensions (strip plots, dot plots, histograms, jittering, deserves a chapter of its own in such a book, so at the very boxplots, scatterplots, cycle-based time series plots), followed least the introduction should clearly announced that the book by Trellis graphics and other ways to display more than one is printed in black-and-white and hence omits the issues variable (including scatterplot matrices, mosaic plots, linked regarding colour. Another problem is that even though the micromaps, parallel coordinates and high-low plots). author clearly understands the issue of chartjunk, the top and Returning to general topics, General principles for creating bottom of every page is covered with an inch tall strip of gray effective graphs (including the aspects of visual clarity) are graph-paper pattern. Saving this space and making the book addressed next, then a chapter focuses on Scales (banking to a little narrower and thinner, which could have been done 45o, scale breaks and the controversies around including without abandoning the characteristic form of left- vs. right- zero). The eight chapter brings five convincing case studies of side page "dialogue", could have made this already portable Applying what we’ve learned: before and after examples. Next paperback a real bestseller fitting in really millions of pockets come Some comments on software, while the last chapter and bags of students and professionals. brings ten (supposedly common) Questions and answers. The first appendix is a List of possible graph defects (with a To summarise, this is a book I cannot wholeheartedly urge reference to the page where each issue is addressed), and the everyone to buy, but I do encourage anyone interested to read second is the List of figures with sources (of data and software in a public library if possible, and then buy it if they find it a used). handy reference. It is positioned somewhere inbetween Tufte’s quest for visual and statistical excellence in all data graphics The book is advertised as "a succinct and highly readable and Cleveland’s quest for graphical perfection among guide to creating effective graphs", which is not a severe statisticians. Even though it clearly demonstrates the overstatement because it is indeed highly readable for its wide influence of the author’s mentor (Cleveland) and former audience while answering the questions like "What business affiliations (S-Plus via Bell Laboratories), it is constitutes an effective graph?", "How do I choose the type of relatively objective, whereby the female gender of the author graph that is best for my data?" and "How do I recognize a might have contributed to a distinctly cautious (to some of us misleading graph?" sufficiently well with relatively few words even bland) style. In terms of lower price and more direct and pictures. However, the claim on the back cover that "In utility for business audience, it has harsh competition in the no time you'll graduate from bar graphs and pie charts to works of Stephen Few, and it missed the opportunity to graphs that illuminate data like dot plots … most of them become a standard pocket reference; however, despite notable requiring only inexpensive, easily downloadable software" is deficiencies, Creating More Effective Graphs by Naomi B. not only grossly exaggerated but also misleading. Firstly, Robbins is in my opinion a good and useful book. "graduating" via reading one non-specialist book in a field that actually requires long years of wide and deep study of References statistics, psychology of perception and computing cannot be Bradstreet, T.E. (2007). Naomi B. Robbins: Creating more taken seriously. Secondly, due to its scope the book is effective graphs. Computational Statistics, 22 (4), 661-663. inevitably inclined towards recipes (albeit good-quality) at least as much as it is towards understanding. Thirdly, while Bulsara, M.K. (2006). Book Review: Creating more effective the software it promotes is either completely free and not so graphs. Statistical Methods in Medical Research, 15 (1), 89. easy to use by the general public, as in the case of R, or relatively expensive, as in the case of S-Plus. Miller, J.E. (2007). Book Review: Robbins, N. B. 2005. Creating more effective graphs. Sociological Methods & Speaking of software, Excel, which can be considered virtually Research, 36 (1), 143-146. free because of ubiquitous installations of Microsoft Office, deserves some special attention in relation to this book. Vidmar, G. (2007). Statistically sound distribution plots in Namely, the author’s attitude towards it is clearly Excel. Metodološki zvezki / Advances in Methodology and inconsistent if not schizoid, because its use is discouraged at Statistics, 4 (1), 83-98. [http://mrvar.fdv.uni- several points, followed by sound instructions for producing lj.si/pub/mz/mz4.1/vidmar.pdf] good graphics with it towards the end of the book. Furthermore, although some of its extensions are mentioned and the reader "adept in Excel" is encouraged to find more on

ISCB News #45 Page 32 June 2008

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Society’s Aims

The Society is organised and shall be operated for educational and scientific purposes with the following Aims: • to stimulate research on the biostatistical principles and methodology used in clinical research; • to increase the relevance of statistical theory to clinical medicine; • to promote high and harmonised standards of statistical practice; • to work with other societies and organisations in the advancement of biostatistics; • to promote better understanding of the use and interpretation of biostatistics by the general public, and by national and international organisations and agencies within the public and commercial sectors with an interest in, and/or responsibilities for, public health; and • to provide a common forum for clinicians and statisticians through meetings, seminars and publications

Changes of Address or Email

Please inform the Permanent Office that looks after the membership and mailing list databases. Also, if your email address changes, please inform the Office and the News Editor so that your address is changed in the ISCB database and emailing list (googlegroup).

Information on Submitting Articles

Articles sent via email (Word, HTML or text) on almost any topic are most welcome. This is an informal newsletter for you the readers, so please join in and make ISCB News a magazine that’s even more interesting and fun to read.

ISCB News #45 Page 33 June 2008

ISCB Office and Executive Committee: Contact Details

Who Address Tel: Fax: Email: ISCB Permanent P.O. Box 130, Datavej 24, DK-3460 Birkerod, Denmark +45 4567 2279 +45 7022 office@ iscb.info Office 1571 Contact email for ISCB emailing list (googlegroup) iscb@ googlegroups.com

President: Catholic University Leuven, Biostatistical Centre, U.Z. St. +32 16 336 +32 16 emmanuel.lesaffre@ Emmanuel Rafael, Kapucynenvoer 35, B-3000 Leuven, Belgium 896 336 900 med.kuleuven.be Lesaffre Professor of Biostatistics and Chair of the Department of Biostatistics and Epidemiology, School of Public Health, Catholic University of Leuven, Belgium. My areas of research include the analysis of correlated data (e.g. repeated measurements, longitudinal studies, clustered data analysis, spatial models), models for missing data, the analysis of interval censored data, correction for measurement error/misclassification, measuring agreement, Bayesian methods and in general the developments of new approaches in the clinical trial area (e.g. sequential methodology). I have served the Society as an Executive Committee member from 1999, the first two years as an ordinary member, then four years as Secretary followed by two years of Vice-President. I am looking forward to serve the Society as your next President. It is an exciting opportunity to help the Society to progress in the coming years. I believe that our Society and its activities are not yet enough known in the statistical world. Therefore, we need to enhance the collaboration with other statistical societies but also with epidemiological and medical societies. I believe that this is the way to show that our Society is the place to exchange ideas between statisticians and medical/epidemiological researchers about the development of new statistical methodology but also about the usefulness of existing approaches. Finally, I strongly believe that the future of our Society lies in the hands of our students. It is of great importance that we can attract them to our annual meetings and to our Society activities. Any suggestions which help to realise this are welcome. Vice-President: Institut für Medizinische Biometrie und Informatik, Im +49 6221 56 +49 6221 victor@ imbi.uni- Norbert Victor Neuenheimer Feld 305, D-69120 Heidelberg, Germany 4140 56 4195 heidelberg.de Professor of Biostatistics and Chair of the Department of Medical Biometry and Informatics, Medical Faculty, Ruprecht-Karls- University, Heidelberg, Germany. Main activities are biostatistical consulting of clinical research and responsibility for the conduct and analysis of clinical trials. Methodological areas of interest are multiplicity problems in testing, heterogeneity in Meta-Analyses and flexible designs in clinical trials. I have served ISCB as an Executive Committee member since 2000, and was Treasurer from 2003-06. In 1999, I organised ISCB20 in Heidelberg. As Vice-President, I will try to enlarge the fields of activity of the society, and herewith to increase membership. I would like to make our meetings a discussion forum of all scientists involved in clinical and epidemiological research: Biostatisticians, trialists with medical background and epidemiologists. Secretary: Rue Porot, F-21440 Francheville, France +33 3 80 35 17 Harbajan.Chadha- Harbajan 59 Boreham@ Chadha-Boreham Actelion.Com Senior Biostatistician in the Department of Biometry, Actelion Pharmaceutical Ltd, Basel, Switzerland. My main activities in pharmaceutical statistics involve design, conduct, analysis and reporting of clinical trials and epidemiology studies across a variety of therapeutic areas. I joined the ISCB in 1993 and have been an active member of the Society; firstly as a member of the ISCB Subcommittee on Statistics in Regulatory Affairs and later as Chair of the Local Organising Committee of ISCB23 Conference held in Dijon, France. In 2003 I set up the ISCB Subcommittee on Conference Organising; we have developed the “Conference Organising Guidelines” to help the organisers of future conferences. Linked to Conference Organising, the Subcommittee has created facilities for storing documents from past conferences on the ISCB website. As a member of the newly formed ISCB Subcommittee on Membership, I have been involved with ideas for promoting our Society to increase its membership. I have served on the ISCB Executive Committee for four years, firstly as a member for two years and then as Secretary, taking care of the quarterly teleconferences of the ExCom, the Annual ExCom and General Meetings. As Secretary, I would continue looking after the organisational aspects of the meetings and as an Officer of the ExCom, I would like to help ISCB maintain its unique and friendly character while providing high quality and successful annual meetings. Treasurer: Academic Medical Centre, Dept. of Clinical Epidemiology & +31 20 +31 20 a.h.zwinderman@ Koos Zwinderman Biostatistics, University of Amsterdam, PO Box 22660, 5665820 6912683 amc.uva.nl NL-1100 DD Amsterdam, Netherlands Professor of biostatistics at the department of Clinical Epidemiology, Biostatistics and Bioinformatics at the Academic Medical Center of the University of Amsterdam in the Netherlands. I was trained as a mathematician and psychologist at the university of Groningen (Netherlands) and obtained my PhD at the University of Nijmegen (Netherlands). My thesis concerned consistency of estimators and goodness of fit tests of the random-effects logistic regression model. My biostatistical interests are-amongst others-statistical genetics, repeated measures and monitoring, clinical trials, meta-analysis, and I was involved in numerous clinical trials and epidemiological research projects. I have been a member of ISCB for over 15 years, and was a member of the ExCom for the period 2003- 2006.

News Editor: Chemin du Petit-Bel-Air 115, CH-1226 Thônex, +41 22 700 david_w_warne@ David W. Warne Switzerland 6380 bluewin.ch +41 22 414 3374 Webmaster: Cyncron Biometrics A/S, P.O. Box 130, Datavej 24, +45 4567 2278 +45 7022 bn@ Cyncron.com Bjarne Nielsen DK-3460 Birkerød, Denmark 1571

ISCB News #45 Page 34 June 2008

ISCB Office and Executive Committee: Contact Details (continued)

Who Address Tel: Fax: Email:

Adriano Decarli Istituto di Statistica Medica e Biometria, Università +39 02 +39 02 adriano.decarli@ degli Studi di Milano, Via Venezian 1, I-20133 50320859 50320866 unimi.it Milan, Italy

KyungMann Kim Department of Biostatistics and Medical +1 608 265 +1 608 kmkim@ Informatics, University of Wisconsin School of 6380 265 5579 biostat.wisc.edu Medicine and Public Health, 600 Highland Ave, K6/438 CSC, Madison, WI 57392-4675, USA

Rumana Omar University College London, Statistical Science, +44 20 Rumana@ Gower Street, London WC1E 6BT, United Kingdom 76791877 stats.ucl.ac.uk

Catherine Service d'Informatique, Médicale & Biostatistique, +33 3 80 29 +33 3 80 catherine.quantin@ Quantin DIM, C.H.U. de Dijon, Hopital du Bocage, BP 34 65 29 39 73 chu-dijon.fr 77908, F-21079 Dijon Cedex, France

Jeno Reiczigel Szent Istvan University, Faculty of Veterinary +36 1 478 +36 1 478 jreiczig@ univet.hu Science, Dept. of Biomathematics & Informatics, 4215 4217 Istvan ut 2, H-1078 Budapest, Hungary

Marie Reilly Karolinska Institute, Medical Epidemiology & +46 852 +46 8 Marie.Reilly@ ki.se Biostatistics, Nobelsväg 12a, Box 281, S-171 77 483982 314975 Stockholm, Sweden

Martin Institute of Medical Biometry & Medical +49 761 203 +49 761 ms@ imbi.uni- Schumacher Informatics, Stefan-Meier-Str. 26, D-79104 6661 203 6680 freiburg.de Freiburg, Germany

Vana Sypsa Athens University Medical School, Dept. of Hygiene +30 210 +30 210 vsipsa@ cc.uoa.gr & Epidemiology, M. Asias 75, GR 11527 Athens, 7462193 7462190 Greece

ISCB Membership and Googlegroups Emailing Lists

From Rita Schou (ISCB Office) and David W. Warne (Googlegroups Administrator) Did you know we try to make sure our If you haven’t done so already, please send membership database (in Denmark) is kept us your email address to allow us to contact up to date? you more easily. We also have an electronic mailing list called If you’ve sent us your email, but haven’t iscb@ googlegroups.com, which allows accepted the invitation to join the iscb members from the current and past year to googlegroup, please accept the next be contacted to discuss statistical ideas and invitation by pressing Reply-Send. to receive news about ISCB events. Rest assured that no company will send you From time to time we compare the 2 any junk email – all emails are checked by databases and if we find you’ve got 2 email the Office or the Googlegroup Administrator. addresses, we’ll ask which you prefer.

ISCB News #45 Page 35 June 2008

ISCB Subcommittees: Contact Details

Please contact the chairs of these subcommittees for further information.

Title & Email Terms of Reference Members Email addresses Conference Organising 1. Bring together ISCB conference Chair/Secretary: organisers or ISCB members who Harbajan Harbajan.Chadha-Boreham@ iscb-conf-org@ have an interest in sharing and Chadha-Boreham (CH) Actelion.Com googlegroups.com passing on their knowledge and Members: experience to help future ISCB Emmanuel Lesaffre (B) emmanuel.lesaffre@ conference organisers. med.kuleuven.be 2. Document processes and Bjarne Nielsen (DK) bn@ Cyncron.com systems for assisting ISCB Catherine Quantin (F) catherine.quantin@ conference organisers. chu-dijon.fr 3. Review and update the John Whitehead (UK) j.whitehead@ lancaster.ac.uk documents whenever necessary Koos Zwinderman (NL) a.h.zwinderman@ amc.uva.nl and promote their usage for David W Warne (CH) david_w_warne@ bluewin.ch improving the procedures or Giota Touloumi (GR) gtouloum@ med.uoa.gr meetings. Zdenek Valenta (CZR) valenta@ euromise.cz Education To support and organise one or Chair/Secretary: two day courses on contemporary Rumana Omar (UK) Rumana@ stats.ucl.ac.uk iscb-education@ methods in clinical biostatistics in Members: googlegroups.com locations represented by the Mike Campbell (UK), m.j.campbell@ sheffield.ac.uk Society. Guidelines and a list of Nicole Close (USA), ncclose@ yahoo.com courses offered in the past are Carol Redmond (USA), ckr3@ pitt.edu available. Maria Grazia grazia.valsecchi@ unimib.it Valsecchi (I), Havi Murad (ISR), havim@ gertner.health.gov.il Elisabeth Svensson (S), elisabeth.svensson@ esi.oru.se Catherine Quantin (F) catherine.quantin@ chu-dijon.fr Jeno Reiczigel (H) jreiczig@ univet.hu Eric Cobo (E) erik.cobo@ upc.edu Membership To explore strategies to increase the Chair: ISCB membership by means of: Emmanuel Lesaffre (B) emmanuel.Lesaffre@ Iscb-membership@ 1. Highlighting the unique position of med.kuleuven.be googlegroups.com the ISCB, i.e. bringing together Secretary: clinicians, methodologists, epidemiologists and biostatisticians KyungMann Kim (USA), kmkim@ biostat.wisc.edu 2. Make strategic links with medical and epidemiological societies in order Members: to make publicity at their meetings and Harbajan Harbajan.Chadha-Boreham@ bring clinicians/epidemiologists with a Chadha-Boreham (CH), Actelion.Com methodological/biostatistical interest to Norbert Victor (D), victor@ our ISCB meeting imbi.uni-heidelberg.de 3. Widen the geographical spread of the John Whitehead (UK) j.whitehead@ lancaster.ac.uk ISCB members 4. Ensure the regeneration of our Toshiro Tango (JPN), tango@ niph.go.jp current core membership. Michal michal@ epimgh.mcgill.ca 5. Provide guidelines for future Abrahamowicz (CDN) conference organisers on choosing a Philip Hougaard (DK) phou@ lundbeck.com scientific programme committee that Bjarne Nielsen (DK) bn@ Cyncron.com will help in widening membership Maria Grazia grazia.valsecchi@ unimib.it 6. To consider the future of the Valsecchi (I) Newsletter, including ways to support David W. Warne (CH) david_w_warne@ bluewin.ch the Editor, procedures for transition of editorship. 7. To maintain the ISCB homepage on the World Wide Web and facilitate placement of annual meeting information on the homepage. 8. To consider other communications with members, such as through email or the World Wide Web.

ISCB News #45 Page 36 June 2008

How to Contact the ISCB Subcommittees (continued)

Title & Email Terms of Reference Members Email addresses National Groups 1. To help those who are interested Chair/Secretary: in forming a National Group Julia Singer (A), julia_singer@ baxter.com Iscb-national-groups@ through the approval process. Members: googlegroups.com 2. To review the arrangements with Stanislav Katina (A), stanislavkatina@ hotmail.com the current National Groups, Krista Fischer (EST) Krista.Fischer@ ut.ee specifically regarding financial Ewa Kawalec (PL), mxkawale@ cyf-kr.edu.pl matters. Catherine Quantin (F) catherine.quantin@ chu- 3. To set rules and standards for dijon.fr funding of ISCB members of Norbert Victor (D), victor@ National Groups and others from imbi.uni-heidelberg.de countries with exchange control John Whitehead (UK) j.whitehead@ lancaster.ac.uk restrictions or barriers. 4. The Subcommittee administers the Conference Awards for Scientists for the annual ISCB meetings. Statistics in Regulatory The subcommittee on Regulatory Chair/Secretary:: Affairs Affairs will review, comment upon Jørgen Seldrup (F) Jorgen.seldrup@ and seek to influence the quintiles.com iscb-reg-aff@ development of regulatory Members: googlegroups.com requirements, guidelines and other Helmut Schäfer (D), hsimbe@ documents concerning the med.uni-marburg.de scientific aspects of data Harbajan Harbajan.Chadha-Boreham@ generation, collection, Chadha-Boreham (CH), Actelion.Com management, analysis, and Christoph Gerlinger (D), Christoph.Gerlinger@ reporting. In general, the Schering.de subcommittee will seek out and Anna Petroccione (I) anna.petroccione@ handle all regulatory issues in the nervianoms.com name of the Society with the Martin Schumacher (D) ms@ imbi.uni-freiburg.de approval of the President or in his/her absence, the Vice-President. Student Conference Student conference awards are Chair/Secretary: Awards available for registered KyungMann Kim (USA) kmkim@ biostat.wisc.edu postgraduate students to attend Members: iscb-stud-conf-awrd@ the annual meeting and present a Bruno Cesana (I), cesana@ med.unibs.it googlegroups.com paper. The Subcommittee shall Jan Lanke (S), jan.lanke@ stat.lu.se receive submissions, judge them, Bianca de Stavola (UK), Bianca.Stavola@ lshtm.ac.uk and administer the awards. The Vana Sypsa (GR) vsipsa@ cc.uoa.gr rules are announced in a timely issue of the Newsletter.

ISCB News #45 Page 37 June 2008

ISCB Membership Information

The International Society for Clinical Biostatistics (ISCB) was founded in 1978 to stimulate research into the principles and methodology used in the design and analysis of clinical research and to increase the relevance of statistical theory to the real The composition of the Executive world of clinical medicine. Committee (ExCom) for 2008 is as follows: The ISCB organises an annual scientific meeting which members and non-members Officers: are able to attend. The main objective of the President: Emmanuel Lesaffre (B), annual scientific meetings is to create an Vice-President: Norbert Victor (D), opportunity for the exchange of knowledge, Secretary: Harbajan Chadha-Boreham (CH), experience and ideas among clinicians, Treasurer: Koos Zwinderman (NL). statisticians and members of other Members: disciplines, such as epidemiologists, clinical News Editor: David W. Warne (CH), chemists and clinical pharmacologists, Webmaster: Bjarne Nielsen (DK), working or interested in, the field of clinical Members: Adriano Decarli (I), biostatistics. KyungMann Kim (USA), Rumana Omar (UK), The scientific meetings cover a broad Catherine Quantin (F), Jeno Reiczigel (H), spectrum of biostatistical interests and Marie Reilly (S), Martin Schumacher (D), regularly include sessions on the design and Vana Sypsa (GR). analysis of clinical trials, epidemiology and The Annual General Meeting of the ISCB is statistical methodology, as well as from time organised to coincide with the scientific to time considering more specialist issues meeting. Membership of the Society is such as, for example, education of drawn from around 40 countries worldwide biometricians and biometrics users, and the number of members is about 800. pharmacokinetics, medical data-bases and pharmaco-epidemiology. Meetings in recent years have been held in London (2003), Leiden (2004), Szeged (2005), Geneva (2006) and Alexandroupolis The ISCB also has special Subcommittees (2007). The next meeting will be held in dealing with particular aspects of Copenhagen (2008). A selection of talks at biostatistics. the meetings, for which papers are submitted for review and which are The Society publishes a Newsletter eventually accepted, are published in twice a year. The ISCB News editor is Statistics in Medicine. The ISCB benefits David W. Warne, Chemin du from a special journal concession from John Petit-Bel-Air 115, CH-1226 Thônex, Wiley & Sons Limited, the publishers of Switzerland. Items for inclusion in the Statistics in Medicine, so that members are Newsletter should be sent to him via email able to subscribe to the journal at a to: david_w_warne@ bluewin.ch preferential rate. Membership of the Society is open to all The ISCB also organises courses to cover with an interest in biostatistics. The current particular statistical topics. These are run to annual (to 31 December 2008) Ordinary precede or follow on from the annual membership fee is €40. The Full-time scientific meeting and are given by the Student Membership fee is €20. foremost researchers in the field.

Applications for membership should be sent to: ISCB Permanent Office, Tel: +45 4567 2279 P.O. Box 130, Fax: +45 7022 1571 Datavej 24, email: office@ iscb.info DK-3460 Birkerod, Denmark www: http://www.iscb.info

ISCB News #45 Page 38 June 2008

ISCB Membership Subscription

INTERNATIONAL SOCIETY FOR CLINICAL BIOSTATISTICS

2008 Membership Subscription

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SUBSRCIPTION: Ordinary membership of ISCB (to 31 December 2008): Euros (EUR) 40.00

(please tick one only) Full-time Student Membership of ISCB (to 31 December 2008): Euros (EUR) 20.00 (students should provide a letter from their supervisor or head of department) Have you previously been a member of ISCB? Yes No

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Cheques must be made payable to the International Society for Clinical Biostatistics and returned with this form to the Permanent Office address. Note: Non-Euro cheques, bank cheques not drawn on a UK bank, and cheques not made payable to ISCB will be returned. Bank Transfer: Please transfer direct to: Barclays Bank plc Euro Account No. 6687 4511 PO Box 69 Bank Sort Code: 20-18-15 121 Queen Street Cardiff CF1 1SG IBAN: GB28 BARC 2018 1566 8745 11 UK SWIFT/BIC: BARCGB22

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ISCB News #45 Page 39 June 2008

Calendar

17-21 August 2008 Copenhagen, Denmark ISCB29 Info: Bjarne Nielsen email: bn@ cyncron.com, web: http://www.iscb2008.info

23-27 August 2009 Prague, Czech Republic ISCB30 Info: Zdenek Valenta email: valenta@ euromise.cz

For the latest conference info, see: http://isi.cbs.nl/calendar.htm

Jul 23rd International Workshop on Statistical Modelling. To be held at Sep The Annual Meeting of the German Statistical Society, to be held at 7-11 Utrecht University, the Netherlands. www.fss.uu.nl/iwsm2008 15-18 the University of Cologne, Germany. The plenary sessions are under the frame topic “Statistics in Marketing”. The programme will cover a Jul The XXIVth International Biometric Conference will be at University wide range of topics and will include an outstanding lecture held by a 13-18 College Dublin. The programme includes Invited and Special Sessions, young statistician. (Submissions of talks until 13th Apr 2008). contributed talks and posters, pre-conference short courses. Abstracts Information: Karl Mosler (President, German Statistical Society) Phone: for contributed oral and poster presentations can be submitted from +492214704266 Fax: +492214705084 E-mail: [email protected] 1st Oct 2007-31st January 2008 through the conference website. www.statistische-woche.dstatg.de Information: Leah Duxbury (download leaflet) Phone: +353.1 296 8688 Fax: +353.1 296 8678 E-mail: [email protected] Sep Applied Statistics 2008, to be held in Ribno (Bled), Slovenia. The www.cpregistrations.com/ibc/2008 21-24 conference, organized in Ribno in the vicinity of the beautiful Lake Bled, will provide an opportunity for researchers in statistics, data Jul LASR 2008: The Art and Science of Statistical Bioinformatics. The 27th analysts, and other professionals from various statistical and related 15-17 Leeds Annual Statistical Research Workshop to be held in Leeds, UK. fields to come together, present their research, and learn from each In 2008, we will continue to explore the LASR themes of statistical other. Information: Andrej Blejec Phone: +386 1 423-33-88 Fax: +386 bioinformatics, shape and image analysis, and interdisciplinary 1 257-33-90 E-mail: [email protected] conferences.nib.si/AS2008 statistics. Information: Dr. Stuart Barber Phone: +44 (0)113 343 5146 Fax: +44 (0)113 343 5090 E-mail: [email protected] Oct Statistics Canada's International Methodology Symposium, “Data www.maths.leeds.ac.uk/lasr2008 28-31 Collection: Challenges, Achievements and New Directions” to be held in Gatineau, Quebec, Canada. The symposium consists of contributed Jul Third Workshop on Statistics, Mathematics and Computation and and invited sessions focusing on issues related to data collection such 21-22 First Portuguese-Polish Workshop on Biometry, to be held in the as planning, cost, implementation, efficiency and other topics. See our Communications Museum, Lisbon, Portugal. It will bring together web site for information including a call for papers. Information: Chris researchers in fields of Statistics and Mathematics, with special Mohl E-mail: [email protected] emphasis in areas such as Biostatistics, Biometry, Biomedicine, www.statcan.ca/english/conferences/symposium2008 Biomathematics, Mathematical Epidemiology, including Computational issues. Information: Teresa Oliveira, Nov ISNI2008: International Seminar on Nonparametric Inference, to be +351213916347,+351213973229, E-mail: [email protected] 5-7 held in Vigo, Spain. Information: Jacobo de Uña-Álvarez Phone: www.univ-ab.pt/wemc2008 (+34)986812492 Fax: (+34)986812401, E-mail: [email protected], www.isni2008.com Jul The 9th World Meeting of the International Society for Bayesian 21-25 Analysis (ISBA), is being held on Hamilton Island (Australia). Nov International Workshop on “Flexible modelling: smoothing and Information: Clair Alston Phone: +61 7 31381338 E-mail: 12-14 robustness” (FMSR 2008), Leuven, Belgium. General theme: semi- and [email protected] www.isba2008.sci.qut.edu.au nonparametric analysis and robust statistical methods. Some specific themes: flexible modelling, regularization, model selection, functional Jul Workshop: Current Trends and Challenges in Model Selection and estimation, dependencies and inference for copulas, robust 24-26 Related Areas (Univ. Vienna, Vienna, Austria). Information: Hannes multivariate outlier detection, time-series. Information: Irène Gijbels, Leeb Phone: 203 508 2339 Fax: 203 432 0633 E-mail: Dominik Sznajder E-mail: [email protected] [email protected] http://wis.kuleuven.be/stat/fmsr2008.php http://www.univie.ac.at/workshop_modelselection Dec The 4th World Conference on Computational Statistics & Data Analysis Aug Joint Statistical Meeting, organized by the American Statistical 5-8 of the IASC and the 6th Conference of the Asian Regional Section of 3-7 Association and to be held at the Denver Convention Center, Denver, IASC will be held in Yokohama, Japan. Information: Chairperson of Colorado. www.amstat.org/meetings IASC 2008: Junji Nakano The Institute of Statistical Mathematics, 4-6- 7 Minami-Azabu, Minato-ku, Tokyo 106-8569, Japan E-mail: Aug useR! 2008, the R user conference, takes place at the Department of [email protected] http://www.iasc-ars.org/IASC2008/ 12-14 Statistics, Universität Dortmund, Germany. Information: Uwe Ligges (conference), Achim Zeileis (program) E-mail: [email protected] Dec Journées D'Etude en Statistique (JES 2008): short course on “Modèles www.R-project.org/useR-2008 8-12 à variables latentes et modèles de mélange”, organised by Société Française de Statistique, Marseille Information: Chaire de Statistique Aug The 18th Symposium of the European Regional Section of the IASC Appliquée CNAM case 441, 292 rue Saint-Martin, 75141 Paris Cédex 24-29 COMPSTAT 2008: International Conference on Computational 03 Fax: + 33 1 40 27 25 48 E-mail: [email protected] Statistics, to be held in Porto, Portugal. Fax: (+351)225505050 E-mail: www.sfds.asso.fr/manifest/jes2008.html [email protected] http://www.fep.up.pt/compstat08 Jul 2009 The 27th European Meeting of Statisticians, Toulouse, France Aug Sample Surveys and Bayesian Statistics-Workshop and Conference. 20-24 http://bs-erc.stat.unipd.it 25-29 Southampton Statistical Sciences Research Institute – S3RI, Southampton. Information on registration to the workshop and Aug 2009 Joint Statistical Meeting, Washington, D.C. conference and submission of abstracts of contributed papers can be 2-6 www.amstat.org/meetings found on the conference website www.s3ri.soton.ac.uk/ssbs08/ Aug 2009 International Statistical Institute, 57th Biennial Session, Durban, Sep “Short course on Statistical Genetics featuring Mendel” to be held in 16-22 South Africa. http://www.statssa.gov.za/isi2009/index.aspx 1-5 Coolangatta, Australia and taught by Prof Ken Lange and others from UCLA. This intensive course will cover state-of-the-art statistical Aug 2010 Joint Statistical Meeting, Vancouver, British Columbia, Canada. genetics methods for the detection of genetic loci for complex traits. 1-5 www.amstat.org/meetings Each day will include hands-on computer exercises as well as the general theory behind the methods. Information: Jul 2011 Joint Statistical Meeting, Miami Beach, Florida. www.twins.org.au/files/Statistical_Genetics_2008.pdf E-mail: stat- 31-Aug www.amstat.org/meetings [email protected] 4

Sep RSS 2008 Conference, to be held in Nottingham, UK. The international Aug 2011 International Statistical Institute 58th Biennial Session, Dublin, 1-5 conference of the Royal Statistical Society will feature a scientific 20-27 Ireland. programme which aims to encompass a wide range of statistical interests from across the world. Contributed paper and posters abstracts are welcomed on all topics related to statistics-the deadline for submission is 31 Mar 2008. Information: Paul Gentry 020 7614 3918 E-mail: [email protected] www.rss.org.uk/rss2008

ISCB News #45 Page 40 June 2008