International Society for Clinical NNEEWWSS Biostatistics

Number 56 December 2013 Editor: David W. Warne

Executive Committee 2014 Editorial

Officers ISCB34 in was just as successful as we expected, and President Koos Zwinderman (NL) again attracted over 600 participants. The scientific and social Vice-President, David W. Warne (CH) programmes were a great success and I thoroughly enjoyed a return News Editor, Acting Webmaster visit to one of my favourite cities. Treasurer KyungMann Kim (US) We now look forward to ISCB35 in Vienna, another of Europe’s Secretary Vana Sypsa (GR) most beautiful cities, which will be a first visit to Austria since 1988. It Members will again be very well attended, so do register early. Please read Michal Abrahamowicz (CA) more about the conference in this News and see the website Keith Abrams (UK) www.iscb2014.info. Tomasz Burzykowski (BE) About the time you read this News, we will be launching the 2nd Zsolt Lang (HU) ISCB Survey. Can you remember the 1st? It doesn’t seem that long ago Saskia Le Cessie (NL) but 20 years have flown by since the first one was carried out using a Chris Metcalfe (UK) paper CRF with analysis on a Psion palmtop... A lot of things have Jeremy Taylor (US) moved on since then... a link to the new web-survey will be sent to Zdenek Valenta (CZ) you via email. Please spend a little time to answer the questions and provide your opinions on the Society and how you would like to see it WWW and Email Addresses develop. Other articles of interest include: the President’s mid-term report www www.iscb.info and information about the National Groups from the representatives. Permanent Office [email protected] Thanks to the contributors to this News: Zdenek Valenta and Book Review Editor [email protected] Ulrich Mansmann on behalf of the SCs on NGs and SCAs, Michael Schemper and Georg Heinze of the Vienna LOC and SPC, Sylvain ISCB News: Correspondence Address Larroque and the book reviewers, ISCB Secretary Vana Sypsa for the AGM Minutes and Election Warning, various contributors of ISCB News Editor David W. Warne [[email protected]] photographs from Munich, and Rita Schou of the ISCB Office.

National Group Representatives/Deputies 2014/Websites Subcommittee Chairs/Secretaries 2014

Czech Zdenek Valenta [email protected] sites.google.com/site/iscbcr/home Conference Organising David W. Warne (CH), Geir Egil Eide (NO) Rep. Marek Maly [email protected] Jeno Reiczigel [email protected] efabis.univet.hu:8080/biostat Hungary Education Catherine Quantin (FR), Jeno Reiczigel (HU) Krisztina Boda [email protected] Ewa Kawalec [email protected] www.iscb.pl/ Epidemiology Marie Reilly (SE), Saskia Le Cessie (NL) Poland Krystyna Szafraniec [email protected] National Groups Zdenek Valenta (CZ), Anca Vitcu (RO) Walerian Piotrowski [email protected] Anca Vitcu [email protected] thor.info.uaic.ro/~rng/ Statistics in Regulatory Affairs Christoph Gerlinger (DE), Christos Nakas (GR) Romania Anca Ignat [email protected] Student Conference Awards Ulrich Mansmann (DE), Nadine Binder (DE) Zorana Bizetic [email protected] - Serbia Natasa Bogavac- [email protected] Vaccines Allen Izu (US), Jennifer Nelson (US) Stanojevic

Index

ISCB Membership ...... 2 National Group Report...... 18 ISCB President’s Mid-Term Message ...... 3 Hungarian National Group Report...... 19 ISCB Numbers – We’re Now >210!...... 3 Serbian National Group Report...... 19 Books for Review by Sylvain Larroque ...... 4 Romanian National Group Report...... 19 Book Review by Theo Stijnen (NL) ...... 6 ISCB Partnership with Wiley...... 19 Book Review by Gerd Rosenkranz (CH)...... 6 Book Review by Michael Grayling (UK) ...... 20 Elections for the Executive Committee 2015-16: Early Warning! ...... 7 Advert: MPS Lancaster, UK...... 20 Book Review by Rainer Muche (DE)...... 8 ISCB GENERAL INFORMATION...... 21 ISCB34 Munich: AGM Minutes...... 9 Advertising Rates ...... 21 ISCB35 Vienna 2014: Student Conference Awards (SCA)...... 12 Society’s Aims ...... 21 ISCB35 Vienna 2014: Conference Awards for Scientists (CAS)...... 12 Changes of Address or Email...... 21 ISCB35 Vienna, Austria: 24-28 August 2014: Invitation ...... 13 Information on Submitting Articles...... 21 Honorary Memberships...... 14 ISCB Office & Executive Committee: Contact Details ...... 22 ISCB34 Munich: Memories ...... 15 ISCB Membership and Googlegroups Emailing Lists...... 23 Advert: Chapman and Hall/CRC...... 16 ISCB Subcommittees: Contact Details ...... 24 Education SC Update ...... 17 ISCB Membership Information...... 26 Education SC: Course Organisation Advertising...... 17 ISCB Membership Subscription ...... 27 Polish National Group Report ...... 18 ISCB Calendar...... 28 ISCB Membership

We’re pleased that so many new members have joined ISCB by attending the conference in Munich. We hope all 1020+ of you will renew your membership early in 2014 – please look out for the email in your inbox. If you need any help, please contact [email protected]. end end Dec Dec Dec Dec Dec Dec Dec Nov Nov Dec Nov Nov Nov Nov Nov Dec Nov Dec Dec Dec Jun Dec *=host of Conference 89 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11 12 13 13 Total 261 596 715 698 725 702 685 729 818 797 837 825 756 758 620 808 800 921 862 880 864 993 547 1028 # Countries 23 32 32 31 33 34 37 37 41 40 45 41 40 38 39 40 41 42 39 42 41 43 35 42 1. United Kingdom 50 90 176* 120 144 121 128 169* 135 151 153 141 190* 140 109 133 117 114 124 114 99 130 50 130 2. 30 67 75 84 71 78 72 70 186* 90 87 77 61 57 51 73 48 59 72 61 53 78 36 113 3. Poland [NatGrp] 11 11 24 24 30 21 19 26 34 37 41 41 43 40 49 54 62 66 71 78 82 82 88 4. Romania [NatGrp] 2 4 1 1 1 19 21 30 28 30 31 36 2 67 58 67 67 5. France 30 52 62 50 73 67 52 52 49 53 37 93* 31 41 30 57 41 49 49 119* 48 60 21 66 6. USA 18 45 40 39 41 40 79* 66 76 77 89 78 75 57 51 67 62 74 67 64 93 66 33 63 7. Netherlands 14* 30 38 33 36 29 31 39 35 33 38 39 33 87* 35 44 41 39 49 56 38 57 27 55 8. Hungary [NatGrp] 1 21 17 18 19 25* 27 29 29 33 34 41 48 42 38* 50 44 43 44 42 48 48 49 49 9. Czech Rep. [NatGrp] 1 1111 1 2 211 1 13173628 44* 30 30 41 38 40 10. Denmark 4 58* 38 31 30 32 26 35 38 39 36 46 41 37 37 40 34 154* 54 60 39 50 21 39 11. Japan 2 6 7 5 7 4 10 13 20 12 11 10 10 10 17 17 27 20 26 24 22 9 7 38 12. Belgium 13 22 27 30 30 32 35 29 25 33 36 33 23 27 24 23 32 33 33 32 24 32 13 35 13. Norway 13 18 25 22 12 18 10 10 11 10 16 16 12 14 12 13 12 19 21 15 15 70 13 34 14. Australia 6 9 11 6 9 8 11 9 10 12 8 9 14 8 6 11 11 10 13 18 17 23 15 31 15. Switzerland 14 25 22 80* 33 29 24 25 23 18 23 26 22 23 23 55* 28 26 28 30 15 20 11 29 16. Canada 6 12 14 14 11 13 15 14 9 9 10 14 16 8 12 12 19 22 18 18 68* 14 11 17 17. Austria 4 9 11 13 11 16 13 11 15 18 15 13 16 17 15 14 16 17 15 15 9 10 5 15 18. South Korea 3 1 1 1 6 6 6 5 6 15 19. Sweden 23 51 53 54 58 64 51 45 38 44 88* 50 36 34 24 23 19 27 19 18 12 26 6 13 20. Finland 2 7 7 9 9 9 7 5 1091811 711106 8 8 9 8 6 9 311 21. Greece 111 113161223 50* 5 7 7 5 7 2 11 22. Serbia [NatGrp] 2 13 13 12 10 23. Spain 10 12 18 12 46* 23 14 16 12 11 11 8 7 15 5 9 8 5 14 14 4 13 3 10 24. Italy 16 33 37 32 32 33 26 33 26 63* 29 25 15 25 15 23 24 20 10 15 8 24 7 9 25. India 11111111212232234438826 26. Singapore 364585724624 13315 27. Slovakia 1 1222211123 28. Ireland 12343442323 11 2 1 3 29. Saudi Arabia 1 1 3 30. Brazil 2 1 1 1 1 2 2 2 2 31. Slovenia 12321132121233455436412 32. Israel 13444433 410131078342 212 2312 33. New Zealand 1 1 2122233312225213112 34. Bulgaria 1 1 2 35. China 11233333332 22 12 36. Turkey 11 1 122347231 2 37. South Africa 14132222233323332524411 38. Luxembourg 1 1 2 1 1 39. Venezuela 2 1 1 40. Portugal 1352222553433111262723 1 41. Russia 13332214321111 1 42. Thailand 1111211222 3 1 43. Taiwan 111111 37435 44. Iran 1 1 11413512163 45. Malaysia 212211111332112321 46. Qatar 1 1 47. Vietnam 1 1 48. Argentina 1 1 49. Egypt 1 1 50. Algeria 2 51. Mexico 11111122211 1 1 52. Estonia 2 1 1 1 1 1 53. Cuba 2 2 2 2 2 2 1 1 1 1 54. Indonesia 1 1 1 55. Pakistan 1 1 1 1 56. Kenya 1 1 1 57. Sri Lanka 1 1 1 58. Bangladesh 1 59. United Arab Emirates 1 1 60. Chile 1 61. Malawi 1 1 1 62. Colombia 1 1 1 1 63. Croatia 1 1 1 64. Gambia 1 65. Lithuania 2 66. Kuwait 1 1 67. Sudan 1 68. Ukraine 1 1 69. Philippines 1 70. Zimbabwe 1 71. Oman 1

ISCB News #56 Page 2 December 2013 ISCB President’s Mid-Term Message

From Koos Zwinderman The Society has had a successful year with the well (Vienna), 2015 (Utrecht) and 2016 (Birmingham) reported on attended conference in München in August 2013. The their progress and proposals for conferences up to 2019 were conference was very well organised and had over 600 discussed. The Excom also unanimously supported the Officers’ attendees. We have to thank Ulrich Mansmann, Hans proposal to grant the Society’s honorary membership to our Helge Müller and Kurt Ulm for their work organising the former President Emmanuel Lesaffre. It was a wonderful conference. The Scientific Programme was very exciting, privilege for me to surprise Emmanuel with this Honour during thanks to Tim Friede and the other members of the the Conference Dinner. Scientific Programme Committee. There were many The Society’s subcommittees all met during the conference to highlights, such as the plea for robustness with model- evaluate their work before he conference and new plans for building and validation by Hans van Houwelingen 2013-2014. The Education SC organised 2 courses in target (President’s invited speaker) and Odd Aalen’s question on countries in 2013 and developed a new strategy to raise more handling complex survival data (invited guest of the SPC). proposals for courses. The SCs on Vaccines and Epidemiology The city of München was also very hospitable to us: we both organised mini-symposia in München: on Vaccine efficacy were invited by the city Mayor who hosted the and on Observational studies. The National Groups in Serbia, Conference Reception in the Old Town Hall and we had a Romania, Hungary, Poland and Czech Republic have been very magnificent conference Dinner in a traditional Beer Hall active with national meetings and courses for members in the and danced to the tunes of a magnificent cover-band. We target countries. The SC on Regulatory Affairs commented on also started a new tradition by organising a get-together- the guideline for “Assessing the Strength of Methodological party for student participants and for more senior ISCB Recommendations for Systematic Review and Meta-analysis” members. by the Agency for Healthcare Research and Quality, and Prior to the opening of the conference on Monday, the recently invited comments on two EMA guidelines (on newly elected Executive Committee (ExCom) met on adjustment for baseline covariates and on statistical Sunday to discuss the yearly reports by the President, the methodology for model-based design and analysis of Phase II Treasurer and the subcommittees (SCs). The financial dose finding studies under model uncertainty. situation of the Society was reported on by the Treasurer, Michael Schemper and George Heinze have advanced very well KyungMann Kim, and is –in short- very good. Details were in organising the 2014 ISCB conference in Vienna (24-28 already published in the June News. The Excom and the August: www.iscb2014.info). I hope to meet all of you in this Annual General Meeting on Wednesday during the great city of music. conference approved the financial report. During the Until then I wish you all a Merry Christmas and a happy and Excom meeting, the organisers of the conferences in 2014 successful New Year.

ISCB Numbers – We’re Now >210!

ISCB News #56 Page 3 December 2013 Books for Review by Sylvain Larroque

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

Books for review:

Author(s) Title Publisher Year ISBN Reviewer (country) year email Anderson, Stewart J Biostatistics - A Computing Approach CRC 2012 9781584888345 NA

Baio, Gianluca Bayesian Methods in Health Economics CRC 2012 9781439895559 NA

Berry, Scott M, Bayesian Adaptive Methods for Clinical Trials CRC 2010 9781439825488 NA Carlin, Bradley P, Lee, J Jack, Muller, Peter.

Boutron, Isabelle, Randomized Clinical Trials of Nonpharmacological CRC 2012 9781420088014 NA Ravaud, Philippe, Treatments Moher, David Chang, Mark Monte Carlo Simulation for the Pharmaceutical CRC 2011 9781439835920 NA Industry

Chen, Ding-Geng (Din), Applied Meta-Analysis with R CRC 2013 9781466505995 NA Peace, Karl E

Chen, Ding-Geng, Interval-Censored Time-to-Event Data: Methods and CRC 2012 9781466504257 NA Sun, Jianguo, Peace, Karl E Applications

Cheung, Ying Kuen Dose Finding by the Continual Reassessment Method CRC 2011 9781420091519 NA

Chow, Shein-Chung Design and Analysis of Bioavailability and CRC 2009 9781584886686 NA Bioequivalence Studies (3rd ed.)

Chow, Shein-Chung, Adaptive Design Methods in Clinical Trials (2nd ed.) CRC 2012 9781439839874 NA Chang, Mark

Crowder, Martin J Multivariate Survival Analysis and Competing Risks CRC 2012 9781439875216 NA

Crowley, John, Handbook of Statistics in Clinical Oncology (3rd ed.) CRC 2012 9781439862001 NA Hoering, Antje

De Leon, Alexander R, Analysis of Mixed Data - Methods and Applications CRC 2013 9781439884713 NA Chough KC

Der, Geoff, Everitt, Brian S Applied Medical Statistics Using SAS CRC 2012 9781439867976 NA

Gandrud, Christopher Reproducible Research with R and RStudio CRC 2014 9781466572843 NA

Indrayan, Abhaya Medical Biostatistics (3rd ed.) CRC 2012 9781439884140 NA

Julious, Steven A Sample Sizes for Clinical Trials CRC 2009 9781584887393 NA

Klein, John P, Handbook of Survival analysis CRC 2014 9781466555662 NA van Houwelingen, Hans C, Ibrahim, Joseph G, Scheike, Thomas H

Li, Jialiang, Ma, Shuangge Survival Analysis in Medicine and Genetics [2 copies] CRC 2013 9781439893111 NA Liu, Jen-pei, Chow, Shein- Design and Analysis of Bridging Studies CRC 2012 9781439846346 NA Chung, Hsiao, Chin-Fu

Peace, Karl E Design and Analysis of Clinical Trials with Time-to- CRC 2009 9781420066395 NA Event Endpoints

Vach, Werner Regression Models as a Tool in Medical Research CRC 2012 9781466517486 NA

Xie, Yihui Dynamic Documents with R and knitr CRC 2014 9781482203530 NA

ISCB News #56 Page 4 December 2013 Books for Review (continued)

Reviews in this issue: Author(s) Title Publisher Year ISBN Reviewer (country) year email Herson, Jay Data and Safety Monitoring Committees in CRC 2009 9781420070378 Theo Stijnen (NL) 2013 Clinical Trials [email protected] Chen, Ding-Geng Clinical Trial Data Analysis Using R CRC 2011 9781439840207 Michael Grayling (UK) 2013 (Din), Peace, Karl E [email protected] Chow, Shein-Chung Controversial Statistical Issues in Clinical trials CRC 2011 9781439849613 Rainer Muche (DE) 2013 [email protected] Furberg, Bengt D, Evaluating Clinical Research: All that Glitters is Springer 2007 9780387728988 Gerd Rosenkranz (CH) 2013 Furberg, Curt D not Gold (2nd ed.) [email protected]

Sent recently: Author(s) Title Publisher Year ISBN Reviewer (country) year email Newcombe, Robert G Confidence Intervals for Proportions and CRC 2012 9781439812785 David W. Warne (CH) 2013 Related Measures of Effect Size [email protected] Green, Stephanie, Clinical Trials in Oncology (3rd ed.) CRC 2012 9781439814482 Jo Haviland (UK) 2013 Benedetti, Jacqueline, [email protected] Smith, Angela, Crowley, John Kupper, Lawrence L, Exercises and Solutions in Biostatistical Theory CRC 2010 9781584887225 Michael Grayling (UK) 2013 Neelon, Brian, [email protected] O'Brien, Sean M. van Buuren, Stef Flexible Imputation of Missing Data CRC 2012 9781439868249 Douglas Dover (CA) 2013 [email protected] or Eric Henninger (CH) 2013 [email protected] Lunn, David, The BUGS Book - A Practical Introduction to CRC 2012 9781584888499 Marek Brabec (CZ) 2013 Jackson, Chris, Bayesian Analysis [email protected] Best, Nicky, Thomas, Andrew, Spiegelhalter, David

Sent a long time ago Author(s) Title Publisher Year ISBN Reviewer (country) year email Cosmatos, Dennis, Translational Medicine not received/sent CRC 2008 9781584888727 Andrea Jorgensen (UK) 2011 Chow, Shein-Chung [email protected] Pong, Annpey, Handbook of Adaptive Designs in CRC 2010 9781439810163 Mounir Aout (FR) 2010 Chow, Shein- Pharmaceutical and Clinical Development will [email protected] Chung (eds.) send back Rothman, Mark D, Design and Analysis of Non-inferiority Trials CRC 2011 9781584888048 Sebastien Marque (FR) 2012 Wiens, Brian L, no reply [email protected] Chan, Ivan SF Shoukri, Mohamed M Measures of Inter-observer Agreement and CRC 2010 9781439810804 Elisabeth Svensson (SE) 2013 Reliability (2nd ed.) [email protected] no reply Jackson, J Edward A User's Guide to Principal Components Wiley 2003 9780471471349 Nicole Close (US) 2013 no reply [email protected] Reviewers who didn’t review or return books: Stefan Tigan, Lars Krogsgaard Thomsen, Justin Clayton, Alex Hinke, Istvan Janosi, Gilg Seeber, Sarah White, Koos Lubsen, Dario Gregori, Aurelio Tobias, David A. Aclar, Dick Bezmer, Graham Kimber.

Book publishers’ webpages (Checked 26Nov2013): Cambridge University http://www.cambridge.org/ch/knowledge/other_subject/item5743165/?site_locale=de_CHwww.cambridge.o Press rg/ch/knowledge/other_subject/item5743165/?site_locale=de_CH CRC (Taylor and Francis) http://www.crcpress.com/browse/category/STA Oxford University Press http://ukcatalogue.oup.com/category/academic/medicine/epidemiology/medicalstats.do#.UEMrz6PD43g Springer http://www.springer.com/statistics/textbook+statistics+2?SGWID=0-10139-0-0-0 Wiley http://eu.wiley.com/WileyCDA/Section/id-351216.html

ISCB News #56 Page 5 December 2013 Book Review by Theo Stijnen (NL)

Herson, Jay Data and Safety Monitoring Committees in Clinical Trials CRC 2009 9781420070378

This is a book about best practices in safety monitoring through for a safety variable is neither a necessary nor a sufficient reason to data safety monitoring committees (DMCs) in pharmaceutical terminate a trial. Useful graphical and tabular data displays are industry clinical trials. DMCs are becoming more and more presented, together with statistical methods for testing hypotheses common in clinical trials nowadays, also in academia. Usually one and creating confidence intervals for various measures of of the members is required to be a biostatistician. This book is treatment differences in safety. Much attention is paid to especially useful for medical statisticians having little experience multiplicity problems, including the use of the false discovery rate. with DMCs. The author promotes the use of likelihood methods for assessing evidence. The book assumes that the reader has a basic knowledge of clinical trials, clinical operations, and good clinical practices. The author is Chapter 6 discussed biases and pitfalls in analyzing safety data, very experienced and stood at the cradle of the first DMC in such as arising from unmasking, incomplete follow-up, pharmaceutical industry. spontaneous versus solicited adverse events data collection, early termination due to efficacy, splitting the adverse event descriptions Chapter 1 is introductory. It explains what a DMC is and gives some into too many subgroups, etc. definitions of important terms. It further points out the differences between investigator initiated trials and those sponsored by In chapter 7 the decision making process and the types of decisions pharmaceutical companies. The author likes the term DMCs can make are reviewed. The steps that can be taken when a “stewardship” to indicate the main task of the DMC: members can safety issue arises are discussed. best fulfil their obligations to sponsors and patients by considering Chapter 8 investigates recent trends in the pharmaceutical themselves responsible for the stewardship of the trial, including industry, such as adaptive designs, and how they may affect the both the preservation of the credibility of the trial and the operations of a DMC. protection of patient safety. A very nice and useful feature of this book is the Questions & Chapter 2 details the organisation of safety monitoring committees Answers section, called the DMCounseler, at the end of each describing the interactions between the sponsor, the DMC, the chapter. The questions provide a behind-the-scenes glimpse of Data Analysis Center, the Institutional Review Board, and the DMC meetings, interactions with sponsors, multinational issues, regulatory agencies. personality conflicts etc. All the issues raised are real and stem Chapter 3 explains the nature of DMC meetings. Of special mostly from the author’s own experience. Each chapter starts with importance is the orientation meeting, in which the extent of DMC ‘Bullets to Remember’, which summarizes the most salient lessons responsibilities, reporting event data flow, blinding policy etc. are to be learned in a chapter. There is also a very useful 10 page discussed. A useful table presents a sample agenda format for DMC glossary. meetings. I found this book very useful as a clinical biostatistician with little Chapter 4 is devoted to clinical issues. It is described how safety experience with serving on a DMC. But also biostatisticians with data reviewed by DMCs arise and it is explained what the more experience in DMCs can profit from this book, since it helps in important distinction is between adverse events, serious adverse evaluating their own performance. Though the book primarily events, and severe adverse events. Also the current state of the art focuses on pharmaceutical industry trials, it is almost equally useful of adverse event coding is described. for those working on investigator initiated trials. Chapter 5 discusses statistical methods useful for DMCs. It is emphasized that statistical significance of a treatment difference

Book Review by Gerd Rosenkranz (CH)

Furberg, Bengt D, Furberg, Curt D Evaluating Clinical Research: All that Glitters is not Gold (2nd ed.) Springer 2007 9780387728988

Many books exist on how to design, conduct and analyse clinical trials. The Each chapter is summarized by a handful of key points and most contain purpose of this booklet is different: it intends to guide clinicians from health examples that support the statements made. care and industry to understand the strengths and weaknesses of clinical The booklet contains a glossary that explains terminology of clinical trials trials and to distinguish patient important and methodologically sound and a checklist for the review of publications of clinical studies, both of studies from those which are limited by design, operational constraints and which are very helpful. Cartoons are scattered throughout the text, most of interpretation. which this reviewer enjoyed while reviewing the booklet. The book is divided into 26 chapters, each about one question. The list Does the reviewer agree with everything stated by the authors? By and addresses the essential notion of benefit-to-harm balance; discusses large, yes. There are some areas that would benefit from re-work. That rare strengths and weaknesses of randomized clinical trials and observational adverse events can hardly be detected from normal sized clinical trials is not studies; stresses the importance of an underlying scientific question that is debated – however, this is a downside of any clinical study, not just specified in advance, the necessity for groups being initially comparable and randomized controlled ones. Should a clinical trial really have only one the value of randomization and blinding. None of this is spectacular, primary hypothesis? Why not answer more than one question in a definitive however, these points should be clear from the report or the publication of way if it’s possible (i.e. adjust for multiplicity)? Questions of interim a clinical trial to assess its quality the reliability of its results. analyses are not touched at all. More advanced topics include quality of life, biomarkers, composite One not negligible advantage of the booklet is its size. The 26 chapters fill endpoints, reliability of active controlled trials and the confidence in less than 140 pages in total. They don’t need to be read in sequence but can economic analyses. Also, fundamental questions like how representative be consulted for a specific topic. “Evaluating Clinical Research” is therefore the results of trial can be and how well research translates into clinical care ideal for people who are interested in clinical research but shy away from are addressed. It may clearly be worthwhile to know what happened to the large books. study subjects who disappeared from the analysis and whether publication in a reputable journal guarantees quality.

ISCB News #56 Page 6 December 2013 Elections for the Executive Committee 2015-16: Early Warning!

From Vana Sypsa, Secretary and Harbajan Chadha-Boreham, Nominations Officer

In accordance with the Constitution, we ask for nominations for positions on the Executive Committee for 2015-16. At the end of 2014, the situation will be:

Koos Zwinderman Will retire as President and becomes Past President for one year, 2015. David W Warne After being Vice-President for 2013-14, will become President for 2015-16 and Past-President for 2017. KyungMann Kim Will end his 2nd term as Treasurer and is not eligible for re-election as Treasurer or Secretary but could be elected as Vice-President. Vana Sypsa Ends her 1st term as Secretary and is eligible for re-election as Treasurer, Secretary or Vice-President. Michal Abrahamowicz End their 2nd terms as Ordinary members and are not eligible for re- Tomasz Burzykowski election as Ordinary members, but are eligible for re-election as Saskia Le Cessie Treasurer, Secretary or Vice-President. Zdenek Valenta Keith Abrams End their 1st terms as Ordinary members and are eligible for re-election Zsolt Lang as Ordinary members, or as Treasurer, Secretary or Vice-President. Chris Metcalfe Jeremy Taylor David W Warne Wishes to continue as News Editor and Webmaster. For the end of term it is meant the end of the calendar year (2014).

Nominations for  Vice-President,  Secretary,  Treasurer and  8 ordinary members Please note the following important clauses from are therefore sought. the Constitution: To make a nomination, please download the form “(6.02) The Committee shall consist of the four from the web Officers and at least five but not more than eight [www.iscb.info/files/folders/nominations/iscb_te other members (“Ordinary members”), plus the mplate_nomination_2014.doc] and send it to the Past President, who shall serve only for the Chair of the ISCB Nominations Committee, calendar year immediately following the Harbajan Chadha-Boreham, (harbajan.chadha- Presidency, and co-opted members.” [email protected]). “(6.03) The Ordinary members, who shall be Each nomination will require the signatures of the Members for at least the calendar year prior to Proposer, a Seconder and of the Nominee nomination, must be elected by ballot; their full confirming a willingness to serve. Completed and term of office shall be two calendar years and they signed nomination forms must be received no shall be eligible for re-election for one further full later than 31 August 2014. (scanned forms sent by term up to a maximum of four consecutive email are acceptable.) calendar years.” If there are more nominees than vacant positions, an electronic ballot will be held.

ISCB News #56 Page 7 December 2013 Book Review by Rainer Muche (DE)

Chow, Shein-Chung Controversial Statistical Issues in Clinical trials CRC 2011 9781439849613

Nowadays, planning, execution and evaluation of clinical studies is 21. Enrichment Process in Target Clinical Trials not a linear, standardised process that should only be conducted to 22. Clinical Trial Simulation receive the respective results. In this book, Chow shows that many 23. Traditional Chinese Medicine aspects are not clear but are discussed and applied controversially. Altogether he identifies and treats 27 “Controversial Statistical 24. The Assessment of Follow-On Biologic Products Issues” that often occur. The intention of Chow is not to give a 25. Generalizability/Reproducibility Probability definite solution but to call attention to the particular problem and 26. Good Review Practices to depict the background and some discussion on solution approaches. Most of the chapters end with summarising 27. Probability of Success “Concluding Remarks” and express the author’s opinion and view. One focus of the book lies in formal aspects of the precise They are highly informative. To gain an overview over the various execution and control of a study (Good Statistical Practice (2), aspects mentioned here, it is sufficient to read the introduction and Protocol Amendments (9), Independence of Data Monitoring concluding remarks of the particular chapters. Then the reader will Committee (12), Good Review Practice (26)). Some practical be able to assess whether this aspect is important enough to read problems that arise daily within the execution of clinical studies are the chapter. Before describing the problem in detail, the author mentioned and help is provided to solve these problems. Among illustrates the context and the problem clearly with the help of these are the formulation of hypotheses (5), sample size calculation examples, where possible. (6), randomization/blinding (7), endpoint selection (8), multiplicity It would exceed the frame of this review to describe in detail the (11), missing data (15), and centre grouping (16). In addition, the particular chapters with at least short background information. list shows many more single problems that are mentioned and Most of the chapters indicate problems that are self-standing. covered by Chow. Therefore, an appropriate summary is not always suitable. For As an example, I pick one single aspect that is covered by Chow in example two chapters (4 and 17) describe aspects of the analysis chapter 7.3 in detail: the choice of block size in a (stratified) block on inferiority (bio-equivalence and non-inferiority) with respect to randomization, the randomization method used most commonly. planning (selection of non-inferiority margin, sample size/power) As the block size affects the concealment (probability of correctly and respectively aspects of analysis (selection of model, tests). guessing of the following patient’s therapy) as well as the balance The list of chapter headings is given here, as it is difficult to of the sample size within the groups, this determination is a summarise and group the themes, but the particular aspects may common problem in every day practice of planning clinical trials. be very helpful in planning, execution and/or evaluation of a clinical Chow describes this problem on 13 pages with the concluding study: remark rather to use small block sizes (up to 6) with permuting block sizes. I would prefer to adapt the sample size to the sample 1. Introduction sizes in the strata. But Chow’s considerations depict very well the 2. Good Statistical Practices problems in this aspect of study planning. 3. Bench-to-Bedside Translational Research In my opinion, the readership for which this book is suitable 4. Bioavailability and Bioequivalence comprises people responsible for the planning and execution of clinical studies in academic and pharmaceutical areas. Definitely 5. Hypotheses for Clinical Evaluation and Significance Digits not all mentioned aspects have always be taken into account in 6. Instability of Sample Size Calculations daily routine but they should be available and – if relevant – be 7. Integrity of Randomization/Blinding considered as a discussion basis. I would not recommend this book 8. Clinical Strategy for Endpoint Selection in student education to teach basics of clinical studies because of the many individual problems that are not covered systematically. 9. Protocol Amendments However, the academic teachers may discuss particular themes 10. Seamless Adaptive Trial Design more intensively and point to “Controversial Issues”. I think the 11. Multiplicity in Clinical Trials themes Randomization or Missing Value Imputation are suitable for 12. Independence of Data Monitoring Committee this. This book may also serve as basis for a seminar in MSc study courses in biometry. 13. Two-Way ANOVA versus One-Way ANOVA with Repeated Measures Altogether, it is very valuable that the book calls the reader’s attention to the numerous problems which are relevant every day 14. Validation of QOL Instruments and I recommend to make this book available to personnel in all 15. Missing Data Imputation biometrical university departments, CROs and operating 16. Center Grouping departments in the pharmaceutical industry to enable them to cope with the most important controversial aspects in planning and 17. Non-Inferiority Margin execution of clinical studies. 18. QT Studies with Recording Replicates 19. Multiregional Clinical Trials 20. Dose Escalation Trials

ISCB News #56 Page 8 December 2013 ISCB34 Munich: AGM Minutes

From Vana Sypsa

Munich, 28 Aug 2013 2. Treasurer’s report Participants: KMK presented the following data: President: Koos Zwinderman (KZ) (Netherlands) Conference Account Vice-President: David W. Warne (DWW) (Switzerland) Income NOK EUR Secretary: Vana Sypsa (VS) (Greece) Registration fee 1,781,453 237,513 Treasurer: KyungMann Kim (KMK) (USA) New from ISCB33 Bergen (due to ISCB) 99,767 13,302 ISCB members: Hougaard, Lange (Denmark) - Friede, Mansmann, Pre-conference Course/Mini Symposium fee 287,400 38,318 Binder H, Binder N., Vach, Schmidtmann, König, Zwingers, Leuchs, Rücker, Sponsorship/Exhibitors 246,400 32,851 Jenkne, Ohneberg (Germany) - Stijnen, Le Cessie, van Houwelingen, Excursions/Conference Banquet 266,050 35,471 Schipper, van de Kassteele, Eijkemans, de Wreede (Netherlands) - Lesaffre Total Income 2,681,070 357,455 (Belgium, Netherlands) - Ramsay, Abrahamowicz, Jiang, Wunant (Canada)- Expense Milliren, Pollock, Cornell, Izu, Close, Moodie, Huebner (USA) - Weir, Procter, Jaki, Whitehead, Crowther, Abrams, Day, Metcalfe, Billingham (UK)- Congress organization including facilities 1,225,200 163,351 Assmus, Eide (Norway) - Hockey (New Zealand) - Pascoe, James, Lee Congress management, LOC and SPC 307,745 41,030 (Australia) - Burzykowski (Poland, Belgium) - Giorgi, Michaels, Thalabard Catering and social events 379,805 50,638 (France) - Singer, Schemper, Heinze (Austria) - Reiczigel, Lang (Hungary)- Invited speakers 234,687 31,290 Senn (Luxembourg) - Chadha-Boreham (Switzerland) - Bamia (Greece)- Miscellaneous 164,248 21,898 Kalina, Hrach, Valenta, Katina, (Czech Republic) ExCom & Awards (due from ISCB) 79,485 10,597 (In total: 68 participants) Total Expense 2,391,170 318,804 Agenda Congress Surplus 289,900 38,651 Agenda item Presenter Settlement of dues (- printing of announcement in 2011, - (4,712) 12:00-12:20 1. President’s welcome and KZ membership fees at fixed value, + ExCom & Awards) report Congress Surplus booked 33,939 12:20-12:35 2. Treasurer’s report KMK 3. Subcommittees' reports for discussion - Motion for budget budget results continuation 2014 2013 2012 12:35-12:40 a. Conference organizing DWW INCOME 12:40-12:45 b. Education Jeno Reiczigel Membership fees 21,000 21,000 25,460 (for Catherine Quantin) Conference surplus 25,000 25,000 33,939 12:45-12:50 c. Epidemiology Marie Reilly Advertising plus interest 1,000 2,000 (189) 12:50-12:55 d. National groups Zdenek Valenta Total 47,000 48,000 59,210 12:55-13:00 e. Student conference Nadine Binder EXPENSES awards Permanent Office 20,000 20,000 22,901 13:00-13:05 f. Statistics in regulatory Nicole Close Officers and ExCom 4,000 4,000 6,163 affairs (for Christoph Awards (students, scientists) 4,000 4,000 8,227 Gerlinger) NG travel support 5,000 5,000 3,407 13:05-13:10 g. Vaccines Allen Izu President invited speaker 1,000 1,000 4. Update about future ISCB meetings Workshops 3,000 3,000 2,869 13:10-13:20 a. 2014 Vienna presentation Michael Schemper Newsletter 10,000 10,000 9,414 13:20-13:25 b. Future meetings (2015 KZ Miscellaneous 4,000 4,000 2,961 Utrecht, 2016 Birmingham, Total 51,000 51,000 55,942 2017+) Details for Budget Change 13:25-13:30 5. Any other business KZ  Keep the membership dues unchanged  Deficit budget (€4,000) to reduce the equity 1. President’s welcome and report  Income adjusted downward from €48,000 to €47,000 A short summary of the report given at the ExCom on Sunday  Advertising plus interest from €2,000 to €1,000 was presented by the President. KZ welcomed old and new ISCB members.  Expense kept at previous level €51,000 He listed what has happened during the previous year, i.e.:  Expenses to control - the appointment of new Officers and members in the  Permanent office expenses have been going up ExCom (no ballot was necessary as the number of  Expenses for Officers/ExCom members candidates was equal to the number of positions to be  Expenses for travel awards filled) Based on these data, KMK pointed out that the Society can take on new - the ballot on Constitution changes initiatives. - the new website of the Society. Discussion: He informed the attendants of the AGM that colleagues from Spain, John Whitehead asked about the Officers' costs. KMK answered that there Belgium, France and Slovenia had already expressed their interest to is variation in these costs depending on the conference site. organise an ISCB conference. He asked the attendants to put other Harbajan Chadha-Boreham asked where the website costs appear in the colleagues that they may know from Singapore, Malaysia or Japan in expenses and whether the Permanent Office costs should be expected to contact with the Officers to explore the potential of a future conference in increase. KMK answered that the website cost is included in these areas. He also described briefly the activities of the subcommittees. “Miscellaneous”. Concerning the cost associated with the Permanent Office, Discussion: Simon Day commented that the electronic version of the DWW mentioned that the online registration to the Society results in less Newsletter should not be password protected. KZ responded that this is a effort demanded by the Office. Harbajan Chadha-Boreham also mentioned good comment and will be considered. PMN: the point was clarified: the that the Newsletter could be sent by e-mail to ISCB members and a printed current and past Newsletters are in the members’ area of the website and copy could be included in the conference bag for all participants the Officers agreed whether this should continue at a subsequent An additional question was asked by Nicole Close on the proportion of new teleconference. members who are students.

The approval of last year’s financial report and of the 2014 budget proposal was proposed/seconded by Stephen Senn and Emmanuel Lesaffre. They were approved unanimously.

ISCB News #56 Page 9 December 2013 ISCB34 Munich: AGM Minutes (continued)

3. Subcommittees' reports for discussion - Motion for continuation  In order to make our group and ISCB more popular among young biostatisticians and among other researchers, we continued to 3a.Conference Organising – DWW announce the award called “Young biostatistician of the year”. Changes in Membership: Polish NG: The following joined the SC:  PNG of the ISCB consists now of 85 members.  KyungMann Kim (SPC 2011)  A short course on “Dealing with missing data: concepts, methods, and  Jörg Assmuss (LOC 2012) applications”, will take place on 25-26, October 2013 in Cracow.  Maarten Schipper (LOC 2015) Serbian NG:  Keith Abrams (ExCom 2013-14)  Course Statistical Methods on Clinical Trials, Jasi, Romania 18-20 June, The following left the SC: 2012. Participant: Nataša Bogavac Stanojević (ISCB NG Serbia).  Harbajan Chadha-Boreham (LOC 2002, SC founder)  Course: “Statistics in clinical trials”, Date: 01-02. March and 08-09.  Lutz Edler (SPC 2006, SC Chair) March 2013. Organizer: CRA Academy  Giota Touloumi (LOC 2007) (http://www.cro.rs/page/en/index ) Lecturer: Zorana Bizetic (ISCB NG  Bjarne Bodin (LOC 2008) Serbia), Dusica Gavrilovic (ISCB NG Serbia).  Emmanuel Lesaffre (SPC 2010)  Course “The theory of probability and statistics”, Date: 16. May 2013. David switched from Secretary to Chair: A new Secretary is needed. Organizer: Department of Probability and Statistics, Faculty of Mathematics, University of Belgrade. Lecturer: Iva Kežić (ISCB NG New version of the COSC Guidelines Serbia) “Bayesian statistics in the optimal dose of drug search  Created and refined by Lutz Edler and David Warne (sorry for the (simulation study)”. delays)  Course: “Statistics is all around us”, Date: 09. May 2013. Organizer:  Sent to SC + Lutz + Harbajan in June 2013 for review Department of Probability and Statistics, Faculty of Mathematics,  To be discussed further at ISCB34 in Munich University of Belgrade. Lecturer: Dušica Gavrilović (ISCB NG Serbia)  Standard Budget – KMK? “Statistics in oncology research”.   Future Conferences Biostatistics course. Date: 15.-17. May 2013. Organizer: Department for Biochemistry, Faculty of Pharmacy and biochemistry, University of  Koos has contacted a few people concerning future conferences Zagreb, Croatia. Lecturers: Nataša Bogavac-Stanojevic (ISCB NG  Hasselt 2018 is a strong possibility; no candidate for 2017 yet Serbia), Statistical Methods in Pharmaco-economic Research. Discussion: None. Czech NG:  On Sept 20, 2012, the Group welcomed Stanislav Katina with his 3b. Education - Jeno Reiczigel for Catherine Quantin second invited talk entitled “3D Statistical Analysis of Shape: Course organization Target Countries: Identification and Analysis of Anatomic Curves”.  Romania, 13-21 July 2013: “Summer camp on bioinformatics” (16  On Feb 21, 2013, the Group welcomed Marcel Jiřina (title of his talk: participants) “Some Interesting Properties of Multivariate Spaces”).  Poland, October-November 2013: “Dealing with missing data:  On Apr 4, 2013 the Group welcomed Arnošt Komárek (“Classification concepts, methods, and applications” Based on Joint Continuous and Discrete Longitudinal Data”). Both with financial support from ISCB  On May 31, 2013, the Group organised an international ISCB a 1-day Course organization in Biostatistically Developed Countries course “Generalised Linear Mixed-effects Models: Concepts and  France, 29-31 May 2013: ‘‘Evaluation of predictive models: goodness- Applications” with Prof. Tomasz Burzykowski (attended by 22 of-fit and predictive power’’ L.O.: Michel Chavance, Lecturers: P. participants from 7 European countries (Czech Republic, Poland, Tubert, J. O’Quigley and V. Viallon (87 participants) - No financial Germany, Serbia, Norway, Romania and Italy). support from ISCB Romanian NG: Discussion: None. Jeno invited attendants to let other colleagues know  During 13th-21st July 2013, the RNG organised in Sibiu a sequence of about the possibility to apply for such courses lectures and round-table discussions under the title “Summer Camp on Bioinformatics”. The core session falls under the heading of the 3c. Epidemiology - Saskia Le Cessie for Marie Reilly two-day course “Genetics, Genomic Medicine and Statistics” provided  Membership: The chair has been approached by two ISCB members by professors Philippe Broët and Hervé Perdry from the University of interested to join, which would increase membership to 16 (the Paris-Sud (France). The event is sponsored by and developed under current membership of 14, 4 more than the recommended size, has aegis of ISCB had approval from the president). Websites: Four National Groups have their websites up-and-running:  Mini-symposium in Munich: one of our members (WS) has been  Czech NG https://sites.google.com/site/iscbcr/home involved in organising a mini-symposium on observational studies at  Polish NG http://www.iscb.pl/ ISCB34 in Munich.  Hungarian NG http://www.biostat.hu/  Web-pages: sub-com members have reviewed the new web pages and  Romanian NG http://thor.info.uaic.ro/~rng/ various links have been added by David Warne:  Preparatory works for launching the Serbian NG’s website are http://www.iscb.info/Committees/Epidemiology-(Epid).html currently under way.  Proposed survey?? The sub-com wishes to determine the proportion 2013 CAS Awards whose main area of work is epidemiology. If not available from Rita at  This year the National Groups Sub-committee (NG SC) members permanent office, then a simple on-line survey of ISCB members. received six applications for the ISCB Conference Awards for Scientists  ISCB 35: Contact will be made with organisers at ISCB 34 in Munich, to (CAS). One of the candidates later resorted to applying for the ISCB discuss how they achieved the extensive coverage of epidemiology Student Conference Award instead. sessions and whether the meeting attracted many epidemiologists.  As was the case a year ago, this year's five eligible CAS applicants Discussion: None. Saskia mentioned that the SC decided not to perform the represented well geographically dispersed target countries: Bulgaria, proposed survey Cuba, Czech Republic, India and Poland.  The first prize goes to Denitsa Grigorova (Bulgaria). The same number 3d. National Groups – Zdenek Valenta of points on both legs of evaluation earned a presentation from Jan Seminars, Courses, Conference Organisation Kalina (Czech Republic).The third winner, Malgorzata Cwiklinska- Hungarian NG: Jurkowska, comes from Poland.  With the financial support of the ISCB, the Hungarian NG organised a An Invitation two-day course in October 2012 in Budapest (“Longitudinal models  The National Groups Sub-committee issued an invitation seeking an for discrete data”, Geert Verbeke and Geert Molenberghs - 28 extension of its membership, targeting primarily the countries of participants from five countries). Central & South America and the Caribbean (details are available at  In 2013, the Hungarian National group had 53 members. This year, we the ISCB website in the NG section) continued our monthly group meetings with lectures given by Discussion: None. members as well as by an invited speaker László Mérő.

ISCB News #56 Page 10 December 2013 ISCB34 Munich: AGM Minutes (continued)

3e. Student Conference Awards – Nadine Binder 3g. Vaccines –Allen Izu  There were 11 applications: 2 from Belgium; 2 from Japan; 2 from UK;  The sub-committee held monthly teleconferences. The secretary and 1 each from Australia, Canada, Egypt, the Netherlands, and USA. regularly issued timely and comprehensive minutes.  Four students were selected by the SCA subcommittee based on the  The ISCB Vaccines Sub-committee has organised a mini-symposium submitted abstract and summary of the paper from each applicant. on “Vaccine Efficacy” to be held on Thursday 29 August at the 34th The SC thanks Koos and David for their contribution in selection, and Annual Conference of the ISCB in Munich, Germany. the ISCB to allow us to select one more student than usual for the  The sub-committee’s website continued to be improved and award. maintained by Webmaster Andrew Dunning who retired from the SC This year’s Student Conference Awardees are given below: after several years of invaluable service.  Name Country University Title E-newsletters #22 - #24 were sent out to the mailing list of statisticians working or interested in vaccines research. There are Cattram Australia University of Diagnosing problems with presently more than 250 statisticians maintained on the list. The sub- Nguyen Melbourne imputation models using committee tracked vaccines sessions at statistical conferences and posterior predictive checking: a statistical sessions at vaccines conferences, highlighting them in the simulation study using data e-newsletters. from the Longitudinal Study of  The sub-committee list of selected readings on the statistics of Australian Children vaccine efficacy is a bit stalled and under review. The completed list Anne Benoit Belgium Université Performances of Regression on vaccine safety was first published in Newsletter #17. catholique Models in Estimating Seasonal  Teaching Webinar Seminar Series – This effort continues to be lead de Louvain Influenza Vaccine: Efficacy by Fabian Tibaldi and Zoe Moodie. Our first webinar was delivered on when Sources of Heterogeneity November 7, 2012 as a global t/c by Peter Gilbert from the University are Omitted of Washington and Fred Hutchinson Cancer Research Center Audrey Canada University of Sieve maximum likelihood (“Assessing Immune Correlates of Protection Via Estimation of the Boruvka Waterloo estimation in a Markov illness- Vaccine Efficacy Curve”). death process from interval- Discussion: None. censored data with missing progression status The continuation of all SCs was proposed/seconded by Nicole Close and Muhammad UK Queen Mary, Adaptive Dose Finding in Early KZ. It was approved unanimously. Iftakhar University of Phase Clinical Trials Alam London Incorporating Pharmacokinetic 4. Update about future ISCB meetings Information 4a. 2014 Vienna presentation  As there was a rather small number of applications in total and four Michael Schemper presented details about the scientific as well as the very good applications among these, it was discussed within the social programme of the 35th Annual Conference of ISCB in Vienna (24-28 Subcommittee whether selecting all four students for the award August 2014): 6 pre-conference courses, 6 invited sessions, a panel would be appropriate (high success rate). discussion (EMA’s initiative to publish clinical trials data), 2 mini-symposia, 7  This year, it was the first time that the reviews were carried out conference tours and many options for pre- and post-conference trips. blinded. President's invited speaker will be Thomas Louis.  This year, it was also the first time, that the Subcommittee has initiated an informal ‘Young Researchers’ Get Together’. 4b. Future meetings (2015 Utrecht, 2016 Birmingham, 2017+) Discussion: None. KZ presented the proposals for future conferences: Vienna (2014), Utrecht (2015), Birmingham (2016). Other potential organisers include Belgium, 3f. Statistics in Regulatory Affairs - Nicole Close for Christoph Gerlinger Spain and France.  In the past, the committee commented on statistical guidelines from drug licensing agencies such as the FDA or the EMA. We extended our 5. Any other business scope to statistical guidelines from health technology assessment Nothing further was discussed and the Annual General Meeting was closed. agencies such as the NICE or the IQWiG.  SiRA commented on the Agency for Healthcare Research and Quality's Minutes Finalised 29 November 2013 (AHRQ) guidance “Framework for Assessing the Strength of Methodological Recommendations for Systematic Review and Meta- Analysis”. Discussion: None. Nicole asked anyone aware of new guidelines to contact the Chair of the SC.

ISCB News #56 Page 11 December 2013 ISCB35 Vienna 2014: Student Conference Awards (SCA)

From Ulrich Mansmann The Student Conference Awards (SCA) are available Applications should be sent to: for registered postgraduate students to attend and present a paper at the 35th ISCB Meeting in Vienna, Ulrich Mansmann Austria, from 24-28 August 2014. IBE, University of Munich Three awards will be made. Selection will be made based on an abstract and a summary of a paper to Marchioninistrasse 15 be presented, which should illustrate application of 81377 München statistical methodology to clinical or epidemiological Germany research. Results of particular studies are of interest Tel: +49 89 7095 4491 only if the analysis has methodological implications Fax: +49 89 7095 7491 or shows a novel and interesting application of biostatistics. email: [email protected] The closing date for application is 15 March 2014.

ISCB35 Vienna 2014: Conference Awards for Scientists (CAS)

From Zdenek Valenta The 2014 ISCB Conference Awards for Scientists paper/presentation to Zdeněk Valenta (see the (CAS) are available to biostatisticians from the address below). countries underdeveloped in clinical biostatistics to Abstracts not granted the CAS award will be eligible attend the 2014 ISCB Annual Conference in Vienna, for an independent review by the 2014 Scientific Austria, and present a paper there. Programme Committee (SPC). However, the abstracts Up to 3 CAS awards will be granted in 2014. will be forwarded to the SPC only at the specific request of the applicant. Applications are invited from all areas of biostatistics, including clinical and biomedical Caution: The authors of the abstracts not granted the research, epidemiology, clinical pharmacology, CAS award which are later accepted by the Vienna vaccines research, hospital performance evaluation, SPC, shall not be eligible for additional ISCB support. survival analysis, causal inference, genomics and system biology, functional analysis, etc. However, Full details about the application procedure are given applications with purely theoretical content or those in the full announcement. involving mere routine data analyses are not The closing date for application is 15 March 2014. encouraged. Only original contributions, not previously presented or published before the time of the application will Zdenek Valenta be considered. Also, the applications with purely ISCB Sub-committee on National Groups, Chair theoretical content or those representing mere Dept. of Medical Informatics and Biostatistics routine analyses of data sets are not encouraged by Institute of Computer Science AS CR the ISCB. Pod Vodarenskou vezi 2 This year the CAS award consists of a registration to 182 07 the 2014 ISCB Annual Conference, accommodation, subscription to one short course selected by the Czech Republic applicant, invitation to the Conference Dinner Tel: +420 266 052 094 sponsored by the ISCB, and travel support. Fax: +420 286 581 453 Scientists should submit their completed application Email: [email protected] form, one-page abstract and full poster or

ISCB News #56 Page 12 December 2013 ISCB35 Vienna, Austria: 24-28 August 2014: Invitation

From Michael Schemper and Georg Heinze LOC and SPC Chairs

We are very pleased to invite you to the next ISCB aging, and Genomics-based Personalized Medicine (joint conference in Vienna, Austria, 24 - 28 August 2014. with the succeeding IGES-Conference in Vienna). The Scientific Programme Committee has defined many A variety of full- and half-day courses are offered: interesting topics from the field of Biostatistics for this  Handling missing outcome data in randomized trials, conference (e.g. design and analysis of clinical trials,  Competing risks and multi-state models, methodological issues and case studies in epidemiology, pharmaceutical statistics and regulatory issues, Bayesian  Statisticians in Data Monitoring Committees, methods in biostatistics, survival analysis, multistate  Extended frailty models for recurrent or clustered models and competing risks, longitudinal data analysis, survival data, methods for handling missing data, statistical methods for  Interaction analysis, systems biology and genetics). More specialised topics are  Statistical methods in Systems Medicine, given on www.iscb2014.info.  Design of adaptive clinical trials. The following invited sessions have been organised: Abstracts can be submitted between 15 January and 15  On trial: integrated care pathways, evidence based March 2014 via the abstract submission system on the medicine and EHRs conference website.  Statistical methods for poly-omics studies Early Bird registration is open until 15 May 2014.  New methods to control for unobserved confounding The traditional excursions on Tuesday, as well as pre-and  Inverse probability weighting techniques post-conference trips will permit you to get a deeper  Prediction to support clinical decision making knowledge and understanding of Vienna, of Austria, and also of our close neighbours; see www.iscb2014.info for  Beyond R packages: getting our methods into various suggestions. standard software The Conference Dinner will take place in one of Vienna’s  The power of data sharing: advancing research for finest historic 19th century palaces, the Palais Ferstel, with everyone's benefit? (Panel discussion) live Viennese ballroom-music and dancing. Please visit www.iscb2014.info for further detail on the The President’s invited speaker, Tom Louis (USA), will talk scientific and social programmes, on abstract submission, about “Why bother with Bayes?” registration, accommodation, and on further practical There will be two Mini-Symposia on the last day of the information for planning your trip. conference: Statistical challenges in the epidemiology of Looking forward to seeing you in Vienna next summer!

ISCB News #56 Page 13 December 2013 Honorary Memberships

From Koos Zwinderman Emmanuel Lesaffre is currently Professor of Biostatistics and Head of the Biostatistics Department at Erasmus Medical Center in Rotterdam (the Netherlands). In addition, he is Professor of Biostatistics at Leuven University (Belgium) and is also attached to Hasselt University (Belgium). Emmanuel Lesaffre studied mathematics at Antwerp University (Belgium) and wrote a PhD thesis on logistic discriminant analysis. He has (co-)authored over 300 scientific papers focusing on development of new biostatistical tools and rigorous application of these tools to medical applications, he (co-)authored over thirty papers in Statistics in Medicine. He authored several books on statistical methods, most recently a book on Bayesian Biostatistics (Wiley, 2012). He has trained and tutored many students both at MSc and PhD levels and many of them have presented their work at ISCB conferences. In recognition of his work, Emmanuel Lesaffre has held several editorships both from statistical journals (Biometrics & Statistical Modeling) and from medical journals and participated as Organiser to several statistical conferences. Emmanuel Lesaffre has been a long time member of the ISCB and contributed tremendously to the Society. He was Secretary and (Vice-)President from 2001-2008, he served as member of the Executive Committee from 1999-2009, and he was a member of several ISCB subcommittees (Membership, Conference Organising, Education, Student Conference Awards) and initiated the subcommittee stimulating application of biostatistical methods in Dentistry research. Finally, Emmanuel Lesaffre was chair of the Scientific Programme Committee of the ISCB conference in Montpellier (2010).

Honorary ISCB Member 2013

Hans Van Houwelingen is a “distinguished biostatistician and has given service of exceptional value and duration to ISCB,” as required by the constitution. Although in retirement since 2007, he has remained very active and we see him every year at the ISCB conference. Hans’ contributions to Biostatistics are well-recognised and the Biometrical Journal 52 (2010) is dedicated to his “40 years in Biostatistics” where it states, “He is considered to be the father of biostatistics in the Netherlands and to put Dutch biostatistics on the map, both nationally and internationally.” At the ISCB Maastricht in 1989, Hans gave a lecture on “predictive value of models” and “shrinkage and validation of prognostic models” and the related paper, which appears in Statistics in Medicine, brought him international recognition. It is one of the most cited papers. Therefore, we can see why the ISCB has a special meaning in Hans’ life and career. Hans has prolific publications of very high standard in many research areas, including Bayes methods, prognostic models, meta-analysis, survival analysis, genetics and bioinformatics in genomics. His interest lies in applications of the methods not only in medicine but also in agriculture. He has one of the longest lists of publications (11) of ISCB conference papers in Statistics in Medicine. Hans has been a regular contributor to the ISCB in significant ways for well over 20 years: Member of the Executive Committee: 1993 – 1996 for two terms, ISCB Scientific Programme Committee Member (3 times): Stockholm (2001); Leiden (2004) & Alexandroupolis (2007), Chair of Local Honorary ISCB Member 2011 Organising Committee, Leiden (2004), Mini-symposium: Genomics based diagnosis and prognosis, Szeged (2005), Pre- conference course: Assessment of predictive performance by cross-validation (in collaboration with Martin Schumacher), Geneva (2006), Invited session papers (2 times): Data analysis when the number of predictors (p) greatly exceeds the number of cases (n), Leiden (2004) and Surrogate markers in clinical trials, Alexandroupolis (2007).

Stephen Senn is one of the most faithful ISCB members: He John Whitehead’s list of merits and services to ISCB is as long attends here his 25th annual meeting, has given many very as that of Stephen; he is without any doubt one of the most exiting lectures (among them the keynote lecture in 2003), he loyal members since the society was established: John contributed 10 papers to the congress issues of Statistics in attended the first ISCB meeting 1979 in Brussels and most of Medicine, and he has taught several pre-conference courses, as our meetings after that, he presented a large number of well as courses in target countries. Stephen became an ordinary papers, he taught several ISCB courses and he contributed the ExCom member in 1991 and served as Secretary from 1992 to highest number (12) of articles to our congress issues of 1995. He also served the Society in many other functions: He Statistics in Medicine. Apart from our first two Honorary was member of several Scientific Programme Committees Members, John has been the ExCom Member with the longest (SPCs, once, Dijon 2003, acting as Chair), editor of the Dijon period of service; this period of twelve years includes four congress issue of Statistics in Medicine, LOC member for ISCB15 years as Treasurer, two years as President and three years as in Basle, and Secretary of the SC “Statistics in Regulatory Vice-/Past-President. John also served the Society in many Affairs”. As Stephen is accepted worldwide – both in academia other functions, e.g. as member of several subcommittees, and the pharmaceutical industry – as an outstanding chair of the Student Conference Awards committee, member biostatistician, there is no need to enumerate his scientific of SPCs and member of the LOC in 2003. John’s reputation as Honorary ISCB Members 2009 merits here. outstanding scientist is undisputed. Therefore, I would like to mention only two of his prominent merits: his role as driving force and teacher in the Biostatistics Master programme in Reading, and his widely used monograph on sequential trials.

David Warne is a longstanding and very faithful ISCB member. Jorgen Seldrup was the Newsletter Editor in 1985 & 1986 and He has been the editor of the Newsletter Editor since 1992-3 in 1990 & 1991, Scientific Secretary from 1987 to 1990, Vice- and served eight Presidents (Claude Chastang, Jorgen Seldrup, President in 1991 & 1992, President in 1993 & 1994 and Past- Marc Buyse, Karsten Schmidt, Simon Day, Grazia Valsecchi, President from 1994 to 1996. In total, he served the Society in John Whitehead, Emmanuel Lesaffre). This is a quite the Executive Committee for a much longer period (1984 to demanding task requiring a lot of secretarial but also 2000). Jorgen has been one of the most loyal ISCB members communication skills. It has been repeatedly confirmed that since The Society has been established in 1979. He has been The Newsletter constitutes an important link for the ISCB member of various ISCB subcommittees but is especially members. In his role as Chair of Communications he has also known for chairing the Subcommittee on Regulatory Affairs for explored various other possibilities to improve the many years, where the main task is the preparation and communications among ISCB members. For instance, he submission of comments on the draft regulatory guidelines. installed the ISCB emailing system thereby creating various Further, he has served in various nominations committees. He dedicated email groups. He also contributed to the is on the Scientific Committee of the meeting in development of the ISCB Website. Further, he is the chair of the Honorary ISCB Members 2007 Alexandroupolis where he is also the Organiser of an invited Subcommittee on Communications and is a member of the session on “vaccines”. For all of these reasons The Officers Subcommittee on Conference Organising. Finally, he Organised recommend Jorgen to receive the status of honorary recently one of the most, if not the most, successful ISCB membership of our Society. meetings in Geneva. Not only the scientific and social programs were excellent, he also realized a substantial financial profit for the Society. For all of these reasons, the Officers recommend David to receive the status of honorary membership of our Society.

ISCB News #56 Page 14 December 2013 ISCB34 Munich: Memories

From David W. Warne, Hans Hockey, Ikuko Funatogawa, Harbajan Chadha-Boreham, KyungMann Kim and the Munich LOC

ISCB News #56 Page 15 December 2013 Advert: Chapman and Hall/CRC

ISCB News #56 Page 16 December 2013 Education SC Update

From Catherine Quantin At the beginning of this year, the Education SC sent out a call for proposals In addition to the financial support offered to target countries (a process requesting applications for financial support for course organisation in adopted quite some time ago), last year the Education SC introduced the Target Countries. Among the three applications, and following discussions opportunity for Biostatistically Developed Countries to take advantage of between the Education SC and the ExCom, 2 of them were finally accepted ISCB prestige as well in a new kind of sponsorship. Indeed, the ISCB intends as eligible for ISCB support: to support the organisation of courses/workshops in Biostatistically  The first course proposal from the Romanian National Group was Developed Countries by lending its name to such events but with no organised by Anca Vitcu and was entitled ‘Summer camp on financial support. One proposal was received which was accepted by the bioinformatics’. This course took place 13-21 July 2013 at the “Al. I. ExCom after consultation with the members of the SC. Cuza” University of Iasi, Romania, with Philippe Broet and Hervé  This course was proposed by Michel Chavance and is entitled Perdry (University of Paris-Sud France) as the invited ISCB experts. The ‘Evaluation of predictive models: goodness-of-fit and predictive financial support brought by the ISCB for this course amounted to power’. It took place in Bordeaux, France 29-31 May 2013. The 1500 euros. The SC has already received its final report, describing the lecturers for this course were Pascale Tubert (INSERM U1018, CESP, overall satisfaction of the audience (9 of 16 participants asserted that Biostatics team, Villejuif, France), John O’Quigley (Université P. et M. their expectations were met while 7 considered them exceeded). Curie, Paris, France) and Vivian Viallon (UMRESTTE-IFSTTAR, Lyon  The second course financially supported was proposed by the Poland Bron, France). The SC has already received its final report, indicating Group with Ewa Kawalec as the local organiser. It was entitled ‘Dealing the overall satisfaction of the audience (83% participants asserted that with missing data: concepts, methods, and applications’ and was held their expectations were met or exceeded). in the Institute of Public Health, University of Krakow 25-26 October Besides sending advertisements, and receiving and assessing applications, 2013. There were one invited speaker for this course: Prof. Tomasz the Education SC is also currently working to improve the routine processes Burzykowski (Hasselt University, Belgium). The ISCB provided 1500 of course support, by redrafting guidelines (not only for TC but also for BDC) euros for this course. The SC has already received its final report, and by overhauling its global workflow, including accurately scheduling the indicating the overall satisfaction of the audience (21 of 32 exchange of information within and outside ISCB. participants asserted that their expectations were met while 10 considered them exceeded).

Education SC: Course Organisation Advertising From Catherine Quantin and Jeno Reiczigel Target Countries Biostatistically Developed Countries The ISCB provides financial support to hold courses on key topics in The ISCB intends to support organisation of courses/workshops in biostatistics for ISCB target countries (which include countries from biostatistically developed countries by lending its name to such events Eastern Europe, Africa, South and South East Asia, the Middle East, South and in doing so, increasing their attractiveness. In return, organisers are and Central America and the Caribbean). expected to provide current ISCB members who would attend the The ISCB Education Subcommittee invites proposals for 2014 from course/workshop with a discount on the registration fee. potential course organisers based in ISCB target countries, to organise Countries concerned are those not included in the ‘ISCB Target short courses on biostatistics topics in the target countries. Countries’ list (which are countries from Eastern Europe, Africa, South Please note that and South East Asia, the Middle East, South and Central America and the Caribbean). This kind of support is open for all such countries. - The course proposal should be made by a local organiser (LO) based in the target country rather than by the speaker(s) of the Please note that course. - The course proposal should be made by the local organiser (LO) of - There is no limit to the number of courses a country/LO can submit, the course rather than by the speaker(s). but a separate application should be completed for each one. - There is no limit to the number of courses a country/LO can submit, - Countries where a course was already supported by the ISCB in the but a separate application should be completed for each one. past can reapply, although this will be taken into account in the - ISCB, as a not-for-profit organization, will not support courses that evaluation of proposals. promote, overtly or covertly, any particular commercial - ISCB, as a not-for-profit organization, will not support courses that solution/company. promote, overtly or covertly, any particular commercial For a list of courses offered by the ISCB since 2000, please visit the solution/company. ‘Education’ section of the ISCB website http://www.iscb.info/. Note that - The financial support never exceeded 2000 Euros per course. it is also possible to send proposals on other topics in biostatistics, and to suggest name(s) of the speaker(s). To help choosing a course topic and to see a list of courses offered by the ISCB or by ISCB members since 2000, please visit the ‘Education’ section Proposals are to be sent electronically to Catherine Quantin, Chair of the of the ISCB website http://www.iscb.info/. Note that it is also possible to ISCB Education Subcommittee ([email protected]) by 31 send proposals on other topics in biostatistics, and to suggest name(s) of January 2014 at the latest. Applications will be submitted to the the speaker(s). President and Officers of the Executive Committee for final decision, and a decision will be made by the end of April 2014. Proposals are to be sent electronically to Catherine Quantin, Chair of the ISCB Education Subcommittee ([email protected]) by 31 For guidance on how to prepare a proposal, please refer to the January 2014 at the latest. Applications will be submitted to the ‘Education’ section of the ISCB website, where a relevant document President and Officers of the Executive Committee for final decision, and entitled “ISCB Courses Final Guidelines” is available to download. If you a decision will be made by the end of April 2014. need further information, please contact Catherine Quantin, Chair of the Education Subcommittee. For guidance on how to prepare a proposal, please refer to the ‘Education’ section of the ISCB website, where a relevant document entitled “ISCB Courses Final Guidelines” is available to download. If you need further information, please contact Catherine Quantin, Chair of the Education Subcommittee. Please forward this announcement to colleagues living in target countries where ISCB is not represented, and encourage them to apply!

ISCB News #56 Page 17 December 2013 Polish National Group Report

From Ewa Kawalec

Activities of the Polish National Group of ISCB (August 2012 – covered the main topics related to the methods for dealing with November 2013) missing data. In particular, the topics included the types of missing data mechanisms, analysis strategies, ignorability, models used to The Polish National Group of ISCB now consists of 89 members. analyze data with missing observations, imputation techniques. No The scientific meetings take place twice a year (usually a summer computer sessions were organised but the lectures were richly meeting in June and a winter meeting in December). This year, the illustrated with practical examples. The course was led by Tomasz summer meeting was held on 28 June and gathered 20 members in Burzykowski from the Center for Statistics of the Hasselt University Cracow. Five of them gave very interesting lectures representing in Belgium. The course was attended by 38 people from 5 countries different fields of statistical applications in medicine. (Austria, Hungary, Italy, Poland, USA). The content of the course, Thanks to the ISCB financial support, 1 member of the PNG, documentation and lectures were rated very well and all Malgorzata Cwiklinska-Jurkowska, was able to present her participants recommended this course. th achievements at the 34 Annual Conference of ISCB in Munich. The next scientific meeting is scheduled for 31 January 2014. Also, thanks to the financial support of ISCB, our Group was able to The homepage of our group (www.iscb.pl in Polish) introduces our organise, together with the Department of Epidemiology and Group to Polish statisticians and others who are interested in Population Studies, Institute of Public Health, Faculty of Health application statistics to medical research. Sciences Jagiellonian University Medical College, a 2-day course on “Dealing with missing data: concepts, methods, and applications”, which took place on 25-26 October in Cracow (Poland). The course

Czech Republic National Group Report

From Zdenek Valenta

At the time of writing the Report, the Czech NG of the ISCB consists randomisation in 24 community pairs in Thailand, Tanzania, of 39 registered members. The current annual membership fee is Zimbabwe and South Africa and discussed the principal results of 200 CZK, which is approximately 8 EUR. this community-based intervention trial, soon about to appear in the Lancet. Since November 2012, the Czech National Group (NG) of the ISCB organised 3 scientific seminars, and another 2 will take place There are still 2 talks scheduled to take place before Christmas. The before Christmas 2013. Furthermore, the Group has also organised first talk, entitled “Assessment of patients with chronic myeloid an international non-sponsored ISCB course in biostatistics. leukaemia in the era of modern pharmacotherapy” is scheduled for 20 November and will be given by Tomáš Pavlík from the Institute On 21 February, the Group welcomed Marcel Jiřina from the of Biostatistics and Analyses of Masaryk University in Brno. Institute of Computer Science AS CR in Prague. His presentation was entitled “Some interesting properties of multivariate spaces”. The last talk this year is about to be given on 11 December by The talk focused on the introduction of metrics and some Ondřej Májek from the Institute of Biostatistics and Analyses of geometrical properties. Jiřina has shown that virtually all Masaryk University in Brno. The title of his talk is going to be multivariate data possess fractal properties and elaborated further “Relative survival modelling in patients with colorectal carcinoma: on how this could be used for practical purposes. do females survive longer than males?” On 4 April, the Group’s members welcomed Arnošt Komárek from All talks were/will be video-recorded and made available to the the Faculty of Mathematics and Physics of the Charles University in NG’s membership via the Group’s website Prague. His contribution was entitled “Classification based on joint (https://sites.google.com/site/iscbcr/) using a secured online continuous and discrete longitudinal data”. The speaker introduced access. a new classification method featuring Bayesian estimation of Finally, the Group organised an international ISCB course with mixture extension of the Generalised Linear Mixed Model. Tomasz Burzykowski of Research at IDDI and Professor of Examples illustrating the new classification method used an R Biostatistics and Bioinformatics at Hasselt University, Diepenbeek, package “mixAK” implemented by Komárek, which is available for Belgium. The course was entitled “Generalised Linear Mixed-effects download from CRAN. Models: Concepts and Applications”. The course took place in On 5 November, the Group welcomed Michal Kulich from the Prague on 31 May 31 and was attended by 24 participants from the Faculty of Mathematics and Physics of the Charles University in Czech Republic (18), and 1 each from Italy, Poland, Germany, Prague. The title of his talk was “Can a behavioral intervention Serbia, Norway and Romania. Participants’ response was decrease HIV incidence? Results from Project ACCEPT, a overwhelmingly positive. The course did not require ISCB community-randomized HIV prevention trial”. The talk concerned sponsorship. the design of the NIH-sponsored trial involving matched-pair

ISCB News #56 Page 18 December 2013 Hungarian National Group Report

From Jenő Reiczigel, Krisztina Boda and Peter Vargha

This year, the Hungarian National group had 54 members. group discussed the ideas she presented and gave her methodological advice. As usual, we met regularly (monthly, except during the summer) and listened to various talks given by the members or by invited Six members of our group attended the annual conference of the speakers. In January, we organised a round-table about biostatistics Society in August in Munich. Thanks for the financial support of education in Hungary. In May, we invited László Mérő ISCB and DFG. (mathematician and psychologist) who gave an interesting talk Seven of us attended the ISCB course “Dealing with missing data – about the role of emotions in human thinking. concepts, methods and applications” in Krakow in November. In 2013, 2 people applied for our “Young biostatistician of the year” Due to some changes of the Hungarian law, we had to make award, but the jury decided not to award the prize because there changes in our constitution, and in consequence we had to hold were too few biostatistics-related points in their applications; in two extra general meetings, one in January and one in May to vote fact they were active in social sciences. However, 1 of the about the changes. Also due to the law changes, our annual general applicants, Ivett Szalma was invited to present her work about meetings must be held in the future in spring. changing attitudes toward artificial insemination in Europe. The

Serbian National Group Report

From Nataša Bogavac-Stanojević 1. Course: “Statistics in clinical trials”, 01-02 and 08-09 March 4. Biostatistics course. 15-17 May 2013. Organiser: Department for 2013. Organiser: CRA Academy Biochemistry, Faculty of Pharmacy and biochemistry, University (http://www.cro.rs/page/en/index ). Lecturers: Zorana of Zagreb, Croatia. Lecturers: Nataša Bogavac-Stanojevic (ISCB NG Bizetic and Dusica Gavrilovic (ISCB NG Serbia). Serbia) “Statistical methods in pharmaco-economic research”. 2. Course “The theory of probability and statistics”, 16 May 5. Informal contact with some institutions. We have made some 2013. Organiser: Department of Probability and Statistics, contact with: Ministry of Health, Institute for Public Health of Faculty of Mathematics, University of Belgrade. Lecturer: Serbia, Medicines and Medical Devices Agency of Serbia and Iva Kežić (ISCB NG Serbia) “Bayesian statistics in the optimal Mathematical faculty of University in Belgrade. In meeting them, dose of drug search (simulation study)”. we have discussed about the role and place of biostatisticians. 3. Course: “Statistics is all around us”, 09 May 2013. 6. Application for Join Research Project. In September, members of Organiser: Department of Probability and Statistics, Faculty ISCB NG Romania and ISCB NG Serbia applied for a Join Research of Mathematics, University of Belgrade. Lecturer: Dušica Project (funded by Swiss National Science). Gavrilović (ISCB NG Serbia) “Statistics in oncology research”.

Romanian National Group Report

Will be available in early 2014.

ISCB Partnership with Wiley

Our publishing partner, Wiley, is extending to all Discover More Ways to Save! members of ISCB a 25% discount on virtually all Wiley For more opportunities to save, join our email print books*. service. In addition to hearing about more special To save offers, you'll find out about new products, author  choose your titles at Wiley.com, appearances, and more.  enter the membership code SD185 in the promotion field in your shopping cart, and *Excludes all German language books and some  click the Apply Discount button major reference works

ISCB News #56 Page 19 December 2013 Book Review by Michael Grayling (UK)

Chen, Ding-Geng (Din), Peace, Karl E Clinical Trial Data Analysis Using R CRC 2011 9781439840207

Since the mid-1990s, use of the R statistical environment has grown apace. Chapters 3 to 12 each introduce a different important clinical trial method. Its user community has expanded exponentially. Today, several thousand The chapters are extremely diverse, with early considerations given to ‘add-on’ packages are available. These packages now cover almost every classical areas such as the use of ANOVA and ANCOVA, to survival analysis, area of statistical analysis, with Clinical Trial Data Analysis not alone in GLMs, power calculations and sample size determination, and even meta- having numerous purpose-built functions at a researcher’s disposal. analysis. More interesting discussions come from the chapter on Bayesian However, despite the great number of packages dedicated to both methods in clinical trials as well as the final chapter on the relatively newer biostatistical methods and their applications, a knowledge gap for area of DNA microarray analysis through the bio-conductor project. Each enthusiasts frequently exists between these two important domains. It is chapter follows a similar route: first outlaying the necessity for such this gap that this book seeks to address. The book fills its purpose well, methods before introducing the data sets that will be used. In each case, successfully covering the majority of the major trial design and analysis the statistical techniques required are then described before reproducible R techniques. At only 387 pages, across 12 chapters, encompassing a vast code for analysis of the trial data is provided. Moreover, graphics are used array of analysis fields, those looking for in-depth explanations of advanced throughout to supplement the text well. The book can be praised for techniques will most likely not find what they desire. What they will find frequently detailing numerous solutions to the same problem, allowing the however, is a good primer to the most commonly used methods and their reader to see the relative benefits of the array of packages available. utilisation in R, as well as extensive lists of references to more detailed As a criticism of the book, we can look firstly to one small oversight. Though considerations. Indeed, in the authors’ other book Clinical Trial it was noted above that the code included is written in a manner that Methodology, extended thoughts were given to roughly the same set of makes it easily adaptable to the reader’s requirements, for those seeking to techniques. However, little to no code was presented. Here though, they repeat the analyses themselves as they read, this becomes an imperative. provide simple examples of how to use a range of available packages, all The data sets used throughout the book have not been provided. This with code that can easily be altered to the reader’s purpose. makes exploiting the book to its full potential particularly tricky for anyone The book begins with a short introduction to R. Instead of providing the without access to suitable data. usual sort of intro available in many texts and throughout the internet, the Undoubtedly, however, the largest criticism is levied at the exclusion of authors introduce the reader via the analysis of some simple, simulated trial discussion of several areas of clinical trial methodology. Very little data. Certainly a new slant on a way to introduce R, it provides a good back- discussion is given to the crossover trial design, despite notable packages drop to the format of the rest of the book. However, for those entirely new available in R. More significantly, no consideration is given to the question to R, it seems almost certain reading one of the recommended of missing data, even though whole books have been dedicated to this introductions at the end of Chapter 1 would be a wiser move. This becomes important issue. It could be argued it was too extensive a problem to even more obvious a necessity when reading the latter chapters. Though for encompass in this introductory text, but it appears throughout as if the the most part the code included is explained, at times some options of the subject has simply been avoided. For those reading the book from a non- employed functions are changed without explanation of the consequences. clinical trial background, you may even leave not realising this problem A good knowledge of R and its help system makes understanding the exists. analysis much easier. In summary, despite failings in some areas, this book can certainly stand on Chapter 2 sets the background to the book’s content through an overview any biostatisticians’ shelf as a useful text. For the seasoned methodologist, of clinical trials. Discussion is made to the utility of each phase in a it provides a helpful introduction to the R environment. For R proponents, it development plan, as well as the need for a clear, concise protocol. Indeed, delivers a simple overview of the established clinical biostatistics much attention is given to the responsibilities of a trial biostatistician; to the methodology. analysis, interpretation and design of a trial from start to end.

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FURTHER DETAILS AND BOOKING: For details of these and other courses offered by the Postgraduate Statistics Centre, go to www.lancs.ac.uk/fas/cpd/statistics/courses or contact Angela Mercer, Postgraduate Statistics Centre, Department of Mathematics and Statistics, Fylde College, Lancaster University, Lancaster LA1 4YF, UK. Tel: +44 1524 593064 email: [email protected]

ISCB News #56 Page 20 December 2013 ISCB GENERAL INFORMATION

Advertising Rates

The prices are: Additionally, we will include loose flyers with the distribution of Full A4 page: € 500 the newsletter at an initial handling cost of € 500. However, if the Half A4 page: € 300 addition of the flyers increases the postal charges, the advertiser Quarter A4 page: € 200 will also be charged the difference in distribution costs. For further information, please contact [email protected]. Publishing dates: Jun 2014 early May 2014 (and deadlines) Dec 2014 early Nov 2014 Adverts sent to the ISCB emailing list of € 750 for 4 emails/year approximately 2000 current and recent members: € 300 for a single email ISCB webpage advertising: € 750 for one year with link from ISCB's homepage

IMPORTANT NOTE: Email Lists and Personal Information ISCB has a strict policy not to give out any information concerning its members to any organisation which requests it. If a company wishes to send material to the members, the brochures must be sent to the Society’s Permanent Office and News Editor for distribution with the News (see above). Alternatively, small non-commercial announcements can be sent free of charge as an email to most members of ISCB.

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

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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 #56 Page 21 December 2013 ISCB Office & Executive Committee: Contact Details

Who SCs Address Tel: Fax: Email:

ISCB Permanent Office: Bregnerodvej 132 A, DK-3460 Birkerod, Denmark +45 2682 7970 [email protected] Rita Schou Contact email for ISCB emailing list (googlegroup) [email protected]

Academic Medical Centre, Dept. of Clinical President: Conf, Epidemiology & Biostatistics, University of [email protected] +31 20 5665820 +31 20 6912683 Koos Zwinderman Vacc Amsterdam, PO Box 22660, NL-1100 DD Amsterdam, a.nl Netherlands Professor of biostatistics at the department of Clinical Epidemiology, Biostatistics and Bioinformatics at the Academic Medical Center of the University of Amsterdam in 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 a variant of the random-effects logistic regression model. My biostatistical interests are-amongst others-statistical genetics, repeated measures and monitoring, clinical trials, and 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, was member of the organising committee of the Leiden conference in 2004, and was a member of the ExCom for the period 2003-2006, and ISCB treasurer 2006-2008. As treasurer I would like to proceed to monitor the financial situation of the Society and help organizing successful scientific conferences that are sufficiently profitable to carry on the Society’s work.

Vice-President, News Editor, Chemin du Petit-Bel-Air 115, CH-1226 Thônex, david_w_warne@bluewin Conf +41 22 700 63 80 Acting Webmaster: Switzerland .ch David W. Warne Consultant Biostatistician, Geneva, Switzerland. Over the last 18 years, my main activities in medical statistics have involved designing clinical development projects, and the design, conduct, analysis and reporting of clinical trials in infertility, leading to approval by various health authorities. I am especially interested in non-inferiority and equivalence studies and in the practical aspects of clinical trials such as randomisation and use of Bayesian methods. In 2010, I moved into a new role focussing on processes, quality and outsourcing. In 2013, I started working as a consultant for various pharmaceutical, biotech and nutrition companies. I joined ISCB in 1992 as Newsletter Editor and have attended all the annual meetings from 1993 and taken part in most of the Executive Committee meetings over the last 20 years. As well as editing over 40 issues of the ISCB News, I was chair of the Communications Subcommittee from 1999-2007 and run the Society’s emailing lists. I have been a member of the Subcommittees on Conference Organising since 2004 and Membership from 2007-12. I was the chair of the Local Organising Committee and co-chair of the Scientific Programme Committee of ISCB27 in Geneva in 2006. In 2007, I was honoured to be made a Life Member of ISCB. I look forward to continue helping with the organisational aspects of the Society and its annual meetings and, as an Officer of the ExCom, I would like to help ISCB maintain its reputation for providing highly successful annual meetings and courses.

Department of Biostatistics and Medical Informatics, Treasurer: University of Wisconsin School of Medicine and Conf +1 608 265 6380 +1 608 265 5579 [email protected] KyungMann Kim Public Health, 600 Highland Ave, K6/438 CSC, Madison, WI 57392-4675, USA Professor of Biostatistics and Statistics, University of Wisconsin-Madison and Director of Biostatistics Shared Resource, University of Wisconsin Carbone Cancer Center. His current area of research includes sequential analysis, clustered data analysis and clinical cancer research. He has been a member of the Society since 1998. He served as an elected member of the ISCB Executive Committee during 2006-2010 and as a member and chair of the Student Conference Award Subcommittee during 2006-2010 and a member of the Membership Subcommittee during 2007-2010. He is very active in professional services to the U.S. National Institutes of Health (NIH) and as data monitoring committee member on many NIH- and industry- sponsored clinical trials in various diseases.

Secretary: Department of Hygiene, Epidemiology and Medical Epid Statistics, Athens University Medical School, M. Asias +30 210 7462193 +30 210 7462190 [email protected] Vana Sypsa 75, 11527, Athens, Greece Lecturer of Epidemiology and Preventive Medicine, Dept. of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School. I received a BSc in Mathematics from the University of Athens, an MSc in Biometry form the University of Reading, UK, and obtained my PhD at the University of Athens. During the 18 years I have been working as a Biostatistician in the University of Athens, I have been involved in the design and analysis of several projects, including clinical trials and epidemiological studies. My current area of research is modeling of infectious diseases and, in general, infectious diseases epidemiology. I served as an elected member of ISCB Executive Committee during 2005-2008, as chair of the Epidemiology Subcommittee during 2009-2012 and as member of the Subcommittee for Student Conference Awards during 2005-2011.

ISCB News #56 Page 22 December 2013 ISCB Office and Executive Committee: Contact Details (continued)

Who SC Address Tel: Fax: Email:

A15 Pharmacy & Bank Building, Faculty of Pharmacy, Michal michal.abrahamowicz@ - The University of Sydney, Sydney NSW 2006, - - mcgill.ca Abrahamowicz Australia

Cong, I-BioStat, Hasselt University, Agoralaan D, B-3590 tomasz.burzykowski@uh +32 11 268243 +32 11 268299 Tomasz Burzykowski NatG Diepenbeek, Belgium asselt.be

Clinical Epidemiology/Medical Statistics and Educ, Bioinformatics, LUMC, C-7, Postbus 9600, NL-2300 RC +31 71 526 2124 - [email protected] Saskia Le Cessie Epid Leiden, Netherlands

Dept. of Medical Informatics & Biostatistics, Institute Conf, zdenek.valenta@fulbrigh of Computer Science AS CR, Pod Vodarenskou vezi 2, +420 266 052 094 +420 286 581 453 Zdenek Valenta NatG tmail.org CZ-182 07 Prague, Czech Republic

Department of Health Sciences, University of Conf, Leicester, 2nd Floor, Adrian Building, University Road, +44 116 229 7266 +44 116 229 7250 [email protected] Keith Abrams StCA Leicester, LE1 7RH, UK

Dept. for Biomathematics and Informatics, Szent Zsolt Lang NatG István University, István u. 2, H-1078 Budapest, +36 4784215 - [email protected] Hungary

School of Social and Community Medicine, University StCA, [email protected] of Bristol, Canynge Hall, 39 Whatley Road, Bristol, +44 117 928 7326 +44 117 928 7325 Chris Metcalfe NatG .uk BS8 2PS, UK

Department of Biostatistics, University of Michigan, Epid, 1415 Washington Heights, Ann Arbor, MI, 48109, +1 734 936 3287 +1 734 763 2215 [email protected] Jeremy Taylor StCA USA

ISCB Membership and Googlegroups Emailing Lists

From Rita Schou (ISCB Office) and David W. Warne (Googlegroup Administrator)

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

ISCB News #56 Page 23 December 2013 ISCB Subcommittees: Contact Details

Please contact the chairs/secretaries of these subcommittees for further information. (*=President’s Representative)

Title & Email Terms of Reference Members Email addresses Conference Organising 1. Bring together ISCB conference Chair: organisers or ISCB members who have an 1. *David W. Warne (CH) [email protected] iscb-conf-org@ interest in sharing and passing on their googlegroups.com knowledge and experience to help future Secretary: ISCB conference organisers. 2. Geir Egil Eide (NO) [email protected] 2. Document processes and systems for Members: assisting ISCB conference organisers. 3. Review and update the documents 3. Keith Abrams (UK) [email protected] whenever necessary and promote their 4. Jörg Assmus (NO) [email protected] usage for improving the procedures or 5. Lucinda Billingham (UK) [email protected] conferences. 6. Tomasz Burzykowski (BE) [email protected] 7. Jacobo de Una Alvarez (ES) [email protected] 8. Jan van de Kassteele (NL) [email protected] 9. KyungMann Kim (US) [email protected] 10. Katherine Lee (AU) [email protected] 11. Ulrich Mansmann (DE) [email protected] 12. Tim Ramsay (CA) [email protected] 13. Michael Schemper (AT) [email protected] 14. Maarten Schipper (NL) [email protected] 15. Zdenek Valenta (CZ) [email protected] 16. Koos Zwinderman (NL) [email protected] Education To support and organise one or two day Chair: courses on contemporary methods in 1. Catherine Quantin (FR) [email protected] iscb-education@ clinical biostatistics in locations googlegroups.com represented by the Society. Guidelines Secretary: and a list of courses offered in the past are 2. Jeno Reiczigel (HU) [email protected] available. Members: 3. *Krisztina Boda (HU) [email protected] 4. Mike Campbell (UK) [email protected] 5. Eric Cobo (ES) [email protected] 6. Alexia Iasonos (US) [email protected] 7. Saskia Le Cessie (NL) [email protected] 8. Rumana Omar (UK) [email protected] 9. Elisabeth Svensson (SE) [email protected] 10. Jean-Christophe Thalabard (FR) [email protected] 11. Maria Grazia Valsecchi (IT) [email protected] Epidemiology 1. Advise the Scientific Programme Chair: Committee of the annual ISCB meetings, if 1. Marie Reilly (SE) [email protected] iscb-epidemiology@ needed, on relevant topics in googlegroups.com epidemiology for establishing invited Secretary: sessions and choosing invited speakers. 2. Saskia Le Cessie (NL) [email protected] 2. Establish connections with Members: Epidemiological Societies and organise 3. Christina Bamia (GR) [email protected] mutual sessions, courses or workshops at our conferences or elsewhere. 4. Harbajan Chadha-Boreham (CH) [email protected] 3. Generate awareness and discussions in 5. Adriano Decarli (IT) [email protected] the Society of guidelines for conducting, 6. Geir Egil Eide (NO) [email protected] analysing and reporting epidemiological 7. Catherine Klersy (IT) [email protected] studies. 8. Elaine Pascoe (AU) [email protected] 9. Catherine Quantin (FR) [email protected] 10. Willi Sauerbrei (DE) [email protected] 11. Ewout Steyerberg (NL) [email protected] 12. Vana Sypsa (GR) [email protected] 13. Jeremy Taylor (US) [email protected]

ISCB News #56 Page 24 December 2013 How to Contact the ISCB Subcommittees (continued)

Title & Email Terms of Reference Members Email addresses National Groups 1. To help those who are interested in Chair: forming a National Group through the 1. *Zdenek Valenta (CZ) [email protected] iscb-national-groups@ approval process. googlegroups.com 2. To review the arrangements with the Secretary: current National Groups, specifically 2. Anca Vitcu (RO) [email protected] regarding financial matters. Members: 3. To set rules and standards for funding of ISCB members of National Groups and 3. Gordana Jovic (UK) [email protected] others from countries with exchange 4. Stanislav Katina (UK) [email protected] control restrictions or barriers. 5. Ewa Kawalec (PL) [email protected] 4. The Subcommittee administers the 6. Arnošt Komárek (CZ) [email protected] Conference Awards for Scientists for the annual ISCB meetings. 7. Zsolt Lang (HU) [email protected] 8. Chris Metcalfe (UK) [email protected] 9. Jenö Reiczigel (HU) [email protected] 10. Elisabeth Svensson (SE) [email protected] Statistics in Regulatory The subcommittee on Regulatory Affairs Chair: Affairs will review, comment upon and seek to 1. Christoph Gerlinger (DE) [email protected] influence the development of regulatory iscb-reg-aff@ requirements, guidelines and other Secretary: googlegroups.com documents concerning the scientific 2. Christos Nakas (GR) [email protected] aspects of data generation, collection, Members: management, analysis, and reporting. In general, the subcommittee will seek out 3. Ralf Bender (DE) [email protected] and handle all regulatory issues in the 4. Harbajan Chadha- [email protected] name of the Society with the approval of Boreham (CH) the President or in his/her absence, the 5. Nicole Close (US) [email protected] Vice-President. 6. Tim Friede (DE) [email protected] 7. Jen-Pei Liu (TW) [email protected] 8. Martin Schumacher (DE) [email protected] 9. Jørgen Seldrup (FR) [email protected] Student Conference Student conference awards are available Chair: Awards for registered postgraduate students to 1. Ulrich Mansmann (DE) [email protected] attend the annual conference and present iscb-stud-conf-awrd@ a paper. The Subcommittee shall receive Secretary: googlegroups.com submissions, judge them, and administer 2. Nadine Binder (DE) [email protected] the awards. The rules and procedures are Members: announced in a timely issue of the Newsletter and on the ISCB annual 3. Keith Abrams (UK) [email protected] conference webpage. 4. Carl-Fredrik Burman (SE) [email protected] 5. Richard Cook (CA) [email protected] 6. Katherine Lee (AU) [email protected] 7. Chris Metcalfe (UK) [email protected] 8. Dimitris Rizopoulos (NL) [email protected] 9. Jean-Christophe Thalabard (FR) [email protected] 10. Jeremy Taylor (US) [email protected] Vaccines 1. Create a professional platform for Chair: statisticians active in the research on 1. Allen Izu (US) [email protected] iscb-vaccines@ vaccines. googlegroups.com 2. Discuss new regulatory guidelines and Secretary: comment upon draft guidelines, in 2. Jennifer Nelson (US) [email protected] collaboration with the subcommittee on Members: Statistics in Regulatory Affairs. Please see 3. Keep up-to-date, discuss, apply and 3. Christele Augard (US) [email protected] www.iscb-vaccines.info encourage relevant statistical and 4. Ivan Chan (US) [email protected] methodological developments. 5. Tammy Massie (US) [email protected] 4. Encourage professional development. 6. Elizabeth Merrall (NL) 5. Organise symposia in the annual ISCB [email protected] SC-Newsletter Editor meetings or in collaboration with ISCB on methodological developments in vaccines 7. Zoe Moodie (US) [email protected] research. 8. Lawrence Moulton (US) [email protected] 9. Fabian Tibaldi (BE) [email protected] 10. *Koos Zwinderman (NL) [email protected]

ISCB News #56 Page 25 December 2013 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 world of clinical medicine. The composition of the Executive Committee The ISCB organises an annual scientific meeting which (ExCom) for 2014 is as follows: members and non-members are able to attend. The Officers: main objective of the annual scientific meetings is to President: Koos Zwinderman (NL), create an opportunity for the exchange of Vice-President/:David W. Warne (CH), knowledge, experience and ideas among clinicians, News Editor/ statisticians and members of other disciplines, such Acting Webmaster as epidemiologists, clinical chemists and clinical Treasurer: KyungMann Kim (US), pharmacologists, working or interested in, the field of Secretary: Vana Sypsa (GR) clinical biostatistics. Members: The scientific meetings cover a broad spectrum of Members: Michal Abrahamowicz (CA), biostatistical interests and regularly include sessions Keith Abrams (UK), on the design and analysis of clinical trials, Tomasz Burzykowski (BE), epidemiology and statistical methodology, as well as Zsolt Lang (HU), from time to time considering more specialist issues Saskia Le Cessie (NL), such as, for example, education of biometricians and Chris Metcalfe (UK), biometrics users, pharmacokinetics, medical Jeremy Taylor (US), databases and pharmaco-epidemiology. Zdenek Valenta (CZ). Meetings in recent years have been held in Geneva The Annual General Meeting of the ISCB is organised (2006), Alexandroupolis (2007), Copenhagen (2008), to coincide with the scientific meeting. Membership Prague (2009), Montpellier (2010), Ottawa (2011), of the Society is drawn from around 40 countries Bergen (2012) and Munich (2013). The next meetings worldwide and the number of members is about will be held in Vienna, Utrecht and Birmingham 1028. (2014-16). A selection of talks at the meetings, for which papers are submitted for review and which are eventually accepted, are published in Statistics in Medicine. The ISCB benefits from a special journal The ISCB also has special Subcommittees dealing with concession from John Wiley & Sons Limited, the particular aspects of biostatistics. publishers of Statistics in Medicine, so that members are able to subscribe to the journal at a preferential The Society publishes a Newsletter twice a rate. year. The ISCB News editor is David W. Warne. Items The ISCB also organises courses to cover particular for inclusion in the Newsletter should be sent to him statistical topics. These are run to precede or follow via email to: [email protected] on from the annual scientific meeting and are given by the foremost researchers in the field. Membership of the Society is open to all with an interest in biostatistics. The current annual (to 31 December 2014) Ordinary membership fee is €40. The Full-time Student Membership fee is €20.

Applications for membership should be sent to: ISCB Permanent Office Tel: +45 2682 7970 Bregnerodvej 132 A, email: [email protected] DK-3460 Birkerod, www: www.iscb.info Denmark

ISCB News #56 Page 26 December 2013 ISCB Membership Subscription

INTERNATIONAL SOCIETY FOR CLINICAL BIOSTATISTICS 2014 Membership Subscription

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Phone No.: Email: Please provide your email address in order to log on to the Fax No.: Members’ Area of ISCB’s website; it may be used to send you the electronic ISCB News in the future, and is needed for voting.

SUBSRCIPTION:  Ordinary membership to 31 December 2014: Euros (EUR) 40.00 Student Membership (applicable to undergraduate or postgraduate -Masters or (please tick one only) PhD- students) to 31 December 2014: 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

New members: Please send this Membership Subscription form to [email protected]. Your details will be uploaded to the Members’ Area of ISCB’s website, and you will be notified when you can follow the procedure below. Current members: Please log in with your email address.

PAYMENT IS MADE BY:  On-line payment You can enter your membership for 2014 in a few easy steps.

 Go to www.iscb.info / Members’ Area  Apply for your password by clicking on “forgotten password”  Type your email address and click on “Send password” You receive your password by email

 Log on to the Members’ Area using your email address and your password.  Click Renew membership on the left-hand bar – accept conditions – accept order – select payment method – Maestro / Master Card / Visa / Visa Electron / JCB - and complete payment. You will receive an email from us confirming that you have renewed your membership once your payment is completed.

Your address details and membership category are already entered into the system. In the Members’ Area you can edit your Profile Settings.

Please note that ISCB’s online payment facility is a secured system; your credit card information cannot be accessed or used for any other purpose.

PS: Danish VISA/Dankort cards are not supported. If you wish to pay your membership fee by bank transfer we ask you kindly to contact the Permanent Office for ISCB’s bank account details ([email protected]). Please return this form either by email to: [email protected] or by post to: ISCB Permanent Office Bregnerodvej 132 A DK-3460 Birkerod Denmark

Tel: +45 2682 7970

ISCB News #56 Page 27 December 2013 ISCB Calendar

ISCB is affiliated to ISI. For the latest conference information, see: isi.cbs.nl/calendar.htm

March 11th German Probability and Statistics Days. In the Aug 2014 Joint Statistical Meetings. To be held at the Boston 4-7 tradition of the previous conferences, it provides an 2-7 Convention and Exhibition Center, Boston, Massachusetts. international forum for the presentation and discussion of Website: http://www.amstat.org/meetings/jsm.cfm

new results in all areas of probability and statistics. The th submission of abstracts for contributed talks is starting Jun Aug 35 Annual Conference of the International Society for 1st, 2013, and ends Nov 30th, 2013. Early bird registration 24-28 Clinical Biostatistics. The conference provides expires January 15th, 2014. For further information please international exchange on theory, methods and have a look at the website. Location: Ulm University. applications of biostatistics in medical research and Website: www.gpsd-ulm2014.de epidemiology. Scientific Programme Committee: Georg Heinze (Vienna, Austria; Chair). Local Organizing April ENBIS-SFdS Spring Meeting on “Graphical Causality Committee: Michael Schemper (Vienna, Austria; Chair). 9-11 Models: Trees, Bayesian Networks and Big Data”. Location: Location: Vienna, Austria. Email: [email protected]. Institut Henri Poincaré in Paris (France). in Paris, France. Website: www.iscb2014.info Organisers: Jean-Michel Poggi (President of SFdS), Ron S. Kenett (Past President of ENBIS), and Alberto Pasanisi 2015: 5th IMS-China International Conference on Statistics and (EDF). Email: Jean-Michel Poggi: Jean Jul 1-4 Probability 2015. Its scientific program will cover a wide [email protected], Ron S. Kenet: ron@kpa- range of topics in probability, statistics and their related group.com, Alberto Pasanisi: [email protected]. areas. The conference will also provide an excellent forum Website: www.enbis.org for scientific exchanges and for forging new research collaborations. Location: Yunnan University, Kunming, Jun International Workshop on Applied Probability (IWAP China. Email: [email protected]. Phone: +86-871- 16-19 2014). The theme of IWAP 2014 is “Probability: The 65033700 Measure of Tomorrow”. It aims. to bring together th researchers to share their views and experiences and. 2015: International Statistical Institute, 60 ISI World Statistics foster collaboration among scientists working in Applied Jul Congress: Includes meetings of the Bernoulli Society, the Probability. The. scientific programme will include plenary 27-31 International Association for Statistical Computing, the talks by outstanding scientists. invited and contributed International Association of Survey Statisticians, the sessions. Location: Antalya-TURKEY. Website: International Association for Official Statistics, the www.iwap2014.org International Association for Statistics Education, the International Society for Business and Industrial Statistics, Jul The Australian Statistical Conference in conjunction with and The International Environmetrics Society. Location: 7-10 the Institute of Mathematical Statistics Annual Meeting Rio de Janeiro, Brazil. Information: ISI Permanent Office, (ASC-IMS 2014). The Conference will be one of the premier P.O. Box 24070, 2490 AB The Hague, The Netherlands. events in 2014 bringing together hundreds of Phone: +31–70–3375737. Fax: +31–70–3860025. Email: isi mathematicians and statisticians from across the globe. @cbs.nl For more information please visit the website. Location: Sydney, Australia. Phone: +61 2 9265 0700. Email: asc- 2015: 36th Annual Conference of the International Society for [email protected]. Website: www.asc-ims2014.com Aug Clinical Biostatistics. The conference provides 23-27 international exchange on theory, methods and Jul ICOTS9: 9th International Conference on Teaching applications of biostatistics in medical research and 13-18 Statistics. Location: Flagstaff, Arizona, USA. Theme: epidemiology. Scientific Programme Committee: Kit Roes “Sustainability in Statistics Education”. Chair International (Utrecht, the Netherlands; Chair). Local Organizing Program Committee: Tim Dunne, South Africa. Website: Committee: Maarten Schipper (Utrecht, the Netherlands; http://icots.net/9/ Chair). Location: Utrecht, the Netherlands. Email: Jul The 29th International Workshop on Statistical Modelling. [email protected]. Website: 14-18 Location: Centre for Statistics, Georg-Aug-Universtität www.ISCB2015.info Göttingen, Germany. The purpose of promoting and 2016: ISCB37. Birmingham, United Kingdom encouraging statistical modelling in its widest sense, Aug involving both academic and professional statisticians and 21-25 data analysts. Invited speakers are A. de Falguerolles (France), A. Jara (Chile), S. Rabe-Hesketh (USA), G. Tutz (Germany) and S. Wood (UK). Submission of abstracts until 31/01/2014. Email: [email protected]. Website: www.uni-goettingen.de/iwsm2014. Website: www.statmod.org

ISCB News #56 Page 28 December 2013