Strategic Plan 2017 - 2021

Total Page:16

File Type:pdf, Size:1020Kb

Strategic Plan 2017 - 2021 discover innovate collaborate STRATEGIC PLAN 2017 - 2021 Better healthcare through research Vision & Direction Better healthcare through research NHMRC Clinical trials Centre (CTC) Key focus areas for 2017 – 2021 EXCELLENCE INNOVATION EVIDENCE aims to be a leading academic Academic clinical trials research Better health practice through Use best evidence to inform best clinical trial research organisation excellence innovative clinical trials practice in Australia and among the most sought after collaborators in the world. We will: Lead quality clinical research Develop new trial methods in Integrate trial evidence for better in theme areas (cancer, CVD, design, biostatistics, risk modelling decision making, guidelines, diabetes, obesity and neonatal) and health economics implementation, policy Mission Our goals are to: - to bring together world-class - to extend our methodological - to combine findings from To embed quality clinical trial expertise in trial methods and work in adaptive trial multiple trials in systematic conduct, clinical disciplines, designs, patient preference reviews and to undertake research into health care biostatistics, health economics, assessment, prognostication, health economic analyses biochemical and molecular diagnostic test evaluation and to provide robust evidence sciences cost-effectiveness analysis in for health care decisions for practical application personalised care, guidelines - build international and policy formulation collaborations Purpose - embed translational studies - deliver quality education, The NHMRC CTC will be recognised as a leader training, teaching and development programs of clinical trials research excellence, the innovator for the conduct of investigator-initiated clinical trials By concentrating on: - research of key questions in - identifying optimal treatment - bridging the evidence-practice cancer, CVD, diabetes, obesity strategies for individual gap and the principal driver for translating clinical trials and perinatal diseases patients and for populations at risk - developing on-line risk evidence into practice. Our approach is to apply - relationship building with assessment tools for collaborative trials groups - incorporating genomics, personalised treatment choice; our inherent strengths, breadth of knowledge and Academic Research molecular biology and new Organisaitons (ARO) to therapeutics linked to clinical - enhancing unbiased systematic and expertise, engage and lead our network of undertake large-scale and/or molecular profiles in reviews, international trials theme areas medical research communities and national and - undertaking meta-analysis to - integrate basic translational - embed health economic further global collaborative international collaborators to advance clinical sciences through the use of evaluation into trial design initiatives. trial-related biospecimens, for trials research. biomarker discovery - development of efficient, novel, - incorporating new findings and adaptive trial designs. into systematic reviews and evidence-based guidelines - platform trials built on trial registries and globally - working with policy makers CORE VALUES: accessible web-based studies and politicians We value integrity, professionalism and collaboration - Increasing the value of clinical trials to the public Better healthcare through research Excellence Academic clinical trials research excellence Through a strong organisational culture and the dedication of focussed staff, we can continue to Strategic objective 1: improve the quality of our research. We will focus on developing new opportunities for the engagement, retention and development of our staff and provide to bring together world-class innovative infrastructure that will support and facilitate the effectiveness and sustainability of our expertise in trial methods and dynamic and productive workplace. We will continue to recognise outstanding effort and leadership that conduct, clinical disciplines, contributes to the quality of our research endeavours. biostatistics, health economics, Four interrelated strategic objectives will help us to achieve our research goal of leading quality clinical biochemical and molecular research in theme areas (cancer, CVD, diabetes, obesity and neonatal). sciences In this 2017–2021 strategy, we have outline three interrelated strategic areas that will help us to achieve our goal of Initiative - research of key questions in cancer, CVD, diabetes, obesity and perinatal diseases becoming the leading academic clinical trial research organisation in Australia and among the most sought after Cancer – We will aim to extend our collaborative clinical trials research program and undertake more collaborators in the world. The key focus areas are within the molecular profile based and immune checkpoint inhibitor clinical trials. Focus will be directed to three themes that underpin our strategic plan : Excellence (in leading large-scale international trials which define best practice for large patient populations by research and education), Innovation and Evidence. assessing the impact of interventions on survival and quality of life. Cardio vascular, diabetes, obesity – We will design and conduct innovative studies to identify novel therapeutic strategies and change practice in large populations Perinatal – We will extend our collaborative trials research program, drive new standards of care in perinatal disease globally and assess economic value of treatments in the field Better healthcare through research Excellence Innovation Strategic objective 2: Strategic objective 3: Better health practice through innovative clinical trials build national and embed translational studies Our goal is to develop new trial methods in design, Strategic objective 5: international collaborations into our trials biostatistics, risk modelling and health economics to extend our methodological Initiative - relationship building with collaborative Initiative - integrate basic translational sciences work in adaptive trial trials groups and Academic Research Organisations through the use of trial-related biospecimens, for (ARO) – nationally and internationally biomarker discovery designs, patient preference assessment, prognostication, We have a long tradition in establishing collaborations New health technologies and new treatments, in diagnostic test evaluation and that enable us to participate in, and lead, particular, genomics, molecular biology and new international clinical trials. We are committed to therapeutics linked to clinical and/or molecular cost-effectiveness analysis in working closely with our established collaborative profiles, have opened to more personalised medicine, partners to develop new concepts in clinical trials where the target trial populations are becoming practical application that answer questions important to the population, smaller. This has increased the potential for greater government and industry. Our focus will be on benefit from personalised care. Well-designed clinical pursuing funding from non-traditional sources to trials integrated with translational research are critical Initiatives include - support the conduct of large-scale clinical trials, raise to real advances in patient care. • identifying optimal treatment strategies for the profile of innovative trial design and incorporate individual patients and for populations at risk new technologies. • incorporating genomics, molecular biology and new therapeutics linked to clinical and/or Through investing in international alliances we have molecular profiles in theme areas attracted like-minded researchers and developed an • embedding health economic evaluation into trial enviable reputation for quality clinical trial design design and conduct. The reputation of our researchers and Strategic objective 4: • developing efficient, novel, and adaptive trial collaborative partners also attracts interest from designs. pharmaceutical companies, governments, health • conducting platform trials built on trial registries services and research organisations, looking for deliver quality education, and globally accessible web-based studies opportunities to support or undertake clinical research on a global scale. training, teaching and A focus for our next stage of strategic growth is development programs We will build on our successful research methods to to extend our collaborative networks and work improve trial design, undertake complex analyses and with consortia whose purpose best aligns with our better synthesise trial evidence to change practice academic and multidisciplinary agenda. Funding from Due to our expertise in the design, conduct and and policy. We aim to further develop expertise and traditional and non-traditional sources will enable interpretation of clinical trials we are uniquely placed leadership in a program of platform trials to allow us to leverage the expertise and collegiality of to provide support and advice to clinical researchers. simultaneous evaluation of multiple biomarkers and extensive established national and international trial We will continue to develop and deliver a program therapies with those showing promise graduating networks and global collaborative hubs to promote of education, training and teaching programs that to larger enriched controlled studies. Research into the development and execution of priority-guided, are aimed at increasing and improving the extent, patient preference, adherence-adjusted estimates of peer-reviewed, investigator- and consumer-driven,
Recommended publications
  • Factors Influencing Clinical Trial Site Selection in Europe
    BMJ Open: first published as 10.1136/bmjopen-2013-002957 on 15 November 2013. Downloaded from Open Access Research Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study) Marta Gehring,1 Rod S Taylor,2 Marie Mellody,3 Brigitte Casteels,4 Angela Piazzi,3 Gianfranco Gensini,5 Giuseppe Ambrosio6 To cite: Gehring M, ABSTRACT et al Strengths and limitations of this study Taylor RS, Mellody M, . Objectives: Applications to run clinical trials in Factors influencing clinical Europe fell 25% between 2007 and 2011. Costs, speed ▪ trial site selection in Europe: We provide systematic evidence across a large of approvals and shortcomings of European Clinical the Survey of Attitudes sample of expert professionals indicating that towards Trial sites in Europe Trial Directive are commonly invoked to explain this fostering competitiveness of European clinical (the SAT-EU Study). BMJ unsatisfactory performance. However, no hard evidence research may not require additional government Open 2013;3:e002957. is available on the actual weight of these factors or has spending/incentives. Carefully crafted harmonisa- doi:10.1136/bmjopen-2013- it been previously investigated whether other criteria tion of approvals, greater visibility of centres of 002957 may also impact clinical trial site selection. excellence via disease networks/the web, and Design: The Survey of Attitudes towards Trial sites in reduction of ‘hidden’ costs are more likely to ▸ Prepublication history for Europe (SAT-EU Study) was an anonymous, cross- boost competitiveness of European clinical this paper is available online. sectional web-based survey that systematically research.
    [Show full text]
  • Industry Roles and Responsibilities
    IBCs in a Changing Research Landscape: A Policy Conference Industry: Roles and Responsibilities Steven A. Kradjian Executive Director, Regulatory Affairs VICAL Incorporated Progress Over 480 gene transfer trials are recorded on the OBA protocol list 86% Phase I studies 13% (64) of these in phase 2 1% (3) of these trials in phase 3. What has changed in the research landscape? Human gene transfer studies moved beyond Phase 1 research to late stage development Phase 2, Phase 3. Better characterized product Industry sponsors ~2/3 of human gene transfer clinical trials. Industry is a major partner in realizing and delivering potential benefits of gene-based medicines. Human Gene Transfer Research: FDA findings of Good Clinical Practices During 2000, FDA inspections 70 clinical study sites Industry and Academic Sponsors GCP compliance acceptable GCP deviations not different from other bioresearch programs Random Sampling of Phase 1 and 2 INDs, FDA March 2000 24 IND Sponsors of 70 Clinical Investigators Human Gene Transfer Participating in these Research INDs Independent 70.8% (17/24) 27.1% (19/70) Government (DHHS) 4.1% (1/24) 7.1% (5/70) Industry 25% (6/24) 65.7% (46/70) Gene Transfer Clinical Investigator Inspections A Comparison FDA inspected 70 randomly selected clinical investigators for GCP compliance. NAI VAI OAI GT 38% 55.9% 5.0% 2000 total 30.9% 57.1% 11.9% 2000w/o GT 21.4% 60% 18.5% 1999 28.5% 54.2% 17.1% 1998 34.9% 53% 12% Random surveillance inspections of Phase 1 and 2 gene therapy clinical trials indicates the trials were being properly conducted with fewer deviations than found in Phase 3 studies.
    [Show full text]
  • UMC Utrecht Research Evaluation
    UMC Utrecht Research Evaluation 2013-2018 Table of contents UMC Utrecht research Self-evaluation report 3 Self-evaluation strategic research program Brain 33 Self-evaluation report strategic research program Cancer 82 Self-evaluation report strategic research program Child Health 150 Self-evaluation report strategic research program Circulatory Health 218 Self-evaluation report strategic research program Infection & Immunity 294 Self-evaluation report strategic research program Regenerative Medicine & Stem Cells 352 UMC Utrecht research Self-evaluation report (2013-2018) Foreword 5 1. Mission, strategy & general organisation 6 1.1 Mission 6 1.2 Strategy 2015-2020 ‘Connecting U’ 6 1.3 Executive Board 6 1.4 Supervisory Board 6 1.5 Organisation 7 1.6 Governance developments 7 1.7 Patient and public involvement 7 1.8 Educational Research 8 2. Research organisation & key figures 9 2.1 Strategic research programs 9 2.2 Management and responsibilities 10 2.3 Research FTE 11 2.4 Professorships 11 2.5 Diversity 11 2.6 Funding and earning capacity 12 2.7 Facilities 14 2.8 Partners and collaborations 14 3. Research policy & support 17 3.1 Research Office 17 3.2 Support for innovation and funding 17 3.3 Compliance and quality management of clinical research 18 3.4 Integrity 18 3.5 Data management 19 3.6 Open Science 19 3.7 Benchmark: Research evaluation practices at the UMC Utrecht 20 4. PhD programs: Graduate School of Life Sciences 22 4.1 Recruitment, selection & admission 22 4.2 PhD enrolment 22 4.3 PhD training 23 4.4 Supervision 24 4.5 Governance 24 5.
    [Show full text]
  • Draft New Drugs and Clinical Trials Rules, 2018
    DRAFT NEW DRUGS AND CLINICAL TRIALS RULES, 2018 SUBMISSIONS TO THE MINISTRY OF HEALTH AND FAMILY WELFARE Dhvani Mehta Nivedita Saksena March, 2018 www.vidhilegalpolicy.in This Report is an independent, non-commissioned piece of academic work. The authors would like to thank Jitin Ahuja for his inputs. The Vidhi Centre for Legal Policy is an independent think-tank doing legal research and assisting government in making better laws. For more information, see www.vidhilegalpolicy.in About the Authors Dhvani Mehta is a Senior Resident Fellow at the Vidhi Centre for Legal Policy working in the Vidhi Aid initiative. Nivedita Saksena is a Research Fellow at the Vidhi Centre for Legal Policy working in the Vidhi Aid initiative. © Vidhi Centre for Legal Policy, 2018 EXECUTIVE SUMMARY 1 EXECUTIVE SUMMARY In a notification dated February 1, 2018, the Central Government invited comments on the draft New Drugs and Clinical Trials Rules, 2018 (“Rules”). These Rules regulate the conduct of clinical trials (including clinical trial related injury and compensation), bioavailability and bioequivalence studies, and the import and manufacture of new drugs. They also govern the functioning of several entities such as the Central Licensing Authority, Ethics Committees and Bioavailability and Bioequivalence Study Centres. These entities and processes are currently governed by scattered provisions contained in the current Drugs and Cosmetics Rules, 1945, several gazette notifications, circulars and office orders. These Rules are a welcome step, and will help to consolidate and streamline the provisions under these different instruments. They will also increase regulatory certainty. However, certain issues must be addressed before these Rules can be effectively implemented.
    [Show full text]
  • Project Final Report
    PROJECT FINAL REPORT Publishable Grant Agreement number: HEALTH-F1-2007-201002 Project acronym: ICREL Project title: IMPACT ON CLINICAL RESEARCH OF EUROPEAN LEGISLATION Funding Scheme: CSA COORDINATION AND SUPPORT ACTION – SA SUPPORTING ACTION Period covered: from 01 January 2008 to 31 December 2008 Project co-ordinator name, Title and Organisation: Dr. Ingrid Klingmann, Project Coordinator, EFGCP Tel: +32 2 784 36 93 Fax: +32 2 784 30 66 E-mail: [email protected] Project website address: www.efgp.be/ICREL 1 ICREL – FINAL REPORT PUBLISHABLE – FEBRUARY 2009 Impact on Clinical Research of European Legislation (ICREL) Final Report – First Version 09 February 2009 European Commission, Directorate Research Grant Agreement Number: HEALTH‐F1‐2007‐201002 Submitted by the European Forum for Good Clinical Practice (EFGCP) in collaboration with European Clinical Research Infrastructures Network (ECRIN) European Organisation for Research and Treatment of Cancer (EORTC) Ethics Committee, Medical University of Vienna Hospital Clinic I Provincial de Barcelona Contact: Dr. Ingrid Klingmann European Forum for Good Clinical Practice Rue de l’Industrie 4 1000 Brussels Belgium Tel: +32 2 732 87 83 E‐mail: [email protected] - 2 - Table of Contents The Consortium....................................................................................................................................7 Executive Summary .............................................................................................................................8 Introduction
    [Show full text]
  • Application of Incident Command Structure to Clinical Trial Management in the Academic Setting: Principles and Lessons Learned Penny S
    Virginia Commonwealth University VCU Scholars Compass Anesthesiology Publications Dept. of Anesthesiology 2017 Application of Incident Command Structure to clinical trial management in the academic setting: principles and lessons learned Penny S. Reynolds Virginia Commonwealth University, [email protected] Mary J. Michael Virginia Commonwealth University Bruce D. Spiess Virginia Commonwealth University Follow this and additional works at: http://scholarscompass.vcu.edu/anesth_pubs Part of the Anesthesiology Commons © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The rC eative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Downloaded from http://scholarscompass.vcu.edu/anesth_pubs/6 This Article is brought to you for free and open access by the Dept. of Anesthesiology at VCU Scholars Compass. It has been accepted for inclusion in Anesthesiology Publications by an authorized administrator of VCU Scholars Compass. For more information, please contact [email protected]. Reynolds et al. Trials (2017) 18:62 DOI 10.1186/s13063-016-1755-9 METHODOLOGY Open Access Application of Incident Command Structure to clinical trial management in the academic setting: principles and lessons learned Penny S. Reynolds1,2*, Mary J. Michael1,2 and Bruce D. Spiess1,2 Abstract Background: Clinical trial success depends on appropriate management, but practical guidance to trial organisation and planning is lacking.
    [Show full text]
  • Annual Work Plan 2020 Would Then Be Updated Accordingly
    Ref. Ares(2020)3206340 - 19/06/2020 In accordance with Article 16 of the Statutes of the IMI2 JU annexed to Council Regulation (EU) No 557/2014 of 6 May 2014 and with Article 33 of the Financial Rules of the IMI2 JU. The third amended Annual Work Plan will be made publicly available after its adoption by the Governing Board. Sole annex to the Decision of the Governing Board of the Innovative Medicines Initiative 2 Joint Undertaking no. IMI2-GB-DEC-2020-20 adopted on 19.06.2020 Page 1 of 238 Table of Contents 1 Introduction ................................................................................................................................................... 5 2 Annual Work Plan Year 2020 ....................................................................................................................... 6 2.1 Executive Summary ....................................................................................................................................... 6 2.2 Operations ..................................................................................................................................................... 6 2.2.1 Objectives & indicators - risks & mitigations ....................................................................................... 6 2.2.2 Scientific priorities for 2020 ............................................................................................................... 14 A. Neurodegeneration and other neuroscience priorities .................................................................
    [Show full text]
  • Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk
    This PDF is available from The National Academies Press at http://www.nap.edu/catalog.php?record_id=18998 Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk ISBN Committee on Strategies for Responsible Sharing of Clinical Trial Data; 978-0-309-31629-3 Board on Health Sciences Policy; Institute of Medicine 280 pages 6 x 9 PAPERBACK (2015) Visit the National Academies Press online and register for... Instant access to free PDF downloads of titles from the NATIONAL ACADEMY OF SCIENCES NATIONAL ACADEMY OF ENGINEERING INSTITUTE OF MEDICINE NATIONAL RESEARCH COUNCIL 10% off print titles Custom notification of new releases in your field of interest Special offers and discounts Distribution, posting, or copying of this PDF is strictly prohibited without written permission of the National Academies Press. Unless otherwise indicated, all materials in this PDF are copyrighted by the National Academy of Sciences. Request reprint permission for this book Copyright © National Academy of Sciences. All rights reserved. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk Sharing Clinical Trial Data Maximizing Benefits, Minimizing Risk Committee on Strategies for Responsible Sharing of Clinical Trial Data Board on Health Sciences Policy PREPUBLICATION COPY: UNCORRECTED PROOFS Copyright © National Academy of Sciences. All rights reserved. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
    [Show full text]
  • Doctors, $$ and Drug Development: T H E R Ise of F Or-P Rofi T E X Perimental M Edicine
    Doctors, $$ and Drug Development: T h e R ise of F or-P rofi t E x perimental M edicine Pierre Azoulay Ariel Fishman M IT and N B E R C olumb ia U niv ersity S loan S chool of M anag ement G rad uate S chool of B usiness 5 0 M emorial D riv e, E 5 2 -5 5 5 3 0 2 2 B road w ay, U ris H all C amb rid g e, M A 0 2 1 4 2 N ew Y ork , N Y 1 0 0 2 7 S ep temb er 1 3 , 2 0 0 6 Abstract Over the past 15 years, academic medical centers have ceased to be the preferred locus of industry-sponsored clinical trial activity. Instead, clinical trials have increasing ly been con- ducted in private practices and for-profi t, dedicated study sites. On the demand side, the g reater availability of non-academic investig ators enabled pharmaceutical fi rms to better match physicians' sk ills w ith specifi c projects. On the supply side, the g row th of manag ed care health insurance has contributed to a rise in the number of physicians w ork ing in the for-profi t clinical trials industry. U sing a uniq ue panel dataset based on information about 9 7 ,2 2 5 clinical trial contracts g ranted betw een 19 9 1 and 2 0 0 3 , w e fi rst show that the proportion of academic in- vestig ators in a clinical trial correlates w ith project characteristics that plausibly prox y for the importance of k now ledg e-production activities.
    [Show full text]
  • Faqs on New Drugs and Clinical Trial Rules 2019
    Central Drugs Standard Control Organization Directorate General of Health Services Ministry of Health and Family Welfare Government of India New Drugs Division Frequently Asked Questions (FAQs) on New Drugs and Clinical Trials Feedback/Suggestions, if any, in this regard, may be submitted to: Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002 Email: [email protected] Notice: The replies to the FAQs are aimed only for creating public awareness about regulation of New Drugs and Clinical Trials and are not meant to be used for legal or professional purposes. The readers are advised to refer to the statutory provisions of Drugs and Cosmetics Act & Rules and respective Guidelines / Clarifications issued by CDSCO from time to time for all their professional needs. FAQs on New Drugs and Clinical Trials 1. Whether the New Drugs and Clinical Trial Rules, 2019 (NDs & CTs Rules, 2019) is applicable only for New Drugs and Investigational New drugs for human use? Yes. Regulation for New drugs for veterinary use will continue to be as per Part XA of the Drugs and Cosmetics Rules, 1945. 2. What is a “new drug”? A new drug means; i. a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent has not been approved as safe and efficacious by Central Licencing Authority (CLA) i.e. DCG(I) with respect to its claims; or ii. a drug approved by the CLA for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or iii.
    [Show full text]
  • Scientific Report 2019
    2006 2007 2008 2009 2010 2011 2012 2013 2014 Tick tock toward 2025 toward tock Tick 2019 REPORT SCIENTIFIC 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 Vall d'Hebron Institute of Oncology (VHIO) CELLEX CENTER C/Natzaret, 115 – 117 08035 Barcelona, Spain Tel. +34 93 254 34 50 www.vhio.net Direction: Amanda Wren Photography: Katherin Wermke Design: Parra estudio Vall d'Hebron Institute of Oncology (VHIO) | 2020 VHIO’s Scientific Report 2019: tick tock toward 2025 1 VHIO’s CELLEX CENTER: translation toward precision oncology 2 VHIO Scientific Report 2019 VHIO’s Scientific Report 2019: tick tock toward 2025 Index VHIO Scientific Report 2019 INTRODUCING VHIO 6 Foreword by VHIO’s Director 16 VHIO in 2019: Tick tock toward 2025 42 Scientific Productivity: research articles 43 Selection of some of the most relevant articles by VHIO researchers published in 2019 FROM THE PROGRAM DIRECTORS 52 Joaquín Arribas 54 Joan Seoane 56 Josep Tabernero PRECLINICAL & TRANSLATIONAL RESEARCH 64 Cellular Plasticity & Cancer Group 66 Chromatin Dynamics in Cancer Group 68 Experimental Therapeutics Group 70 Gene Expression & Cancer Group 72 Growth Factors Group 74 Mouse Models of Cancer Therapies Group 76 Stem Cells & Cancer Group 78 Tumor Biomarkers Group CLINICAL RESEARCH 82 Breast Cancer & Melanoma Group 84 Early Clinical Drug Development Group 86 Experimental Hematology Group 88 Gastrointestinal & Endocrine Tumors Group 90 Genitourinary, CNS Tumors, Sarcoma & Cancer of Unknown Primary Site Group 92 Gynecological Malignancies Group 94 Hereditary Cancer
    [Show full text]
  • Synthesizing Existing Evidence to Design Future Trials: Survey of Methodologists in Europe
    Synthesizing existing evidence to design future trials: survey of methodologists in Europe Adriani Nikolakopoulou1, Sven Trelle1,2, Alex J Sutton3, Matthias Egger1, Georgia Salanti1* 1Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland 2Clinical Trials Unit, University of Bern, Bern, Switzerland 3Department of Health Sciences, University of Leicester, Leicester, UK * Corresponding author 1 Abstract Background: The potential of network meta-analysis to inform the design of future studies is largely underutilised. A suggested framework for efficiently planning clinical trials based on a network of interventions has been termed conditional trial design and consists of three parts. The first part pertains mainly to interpretation of meta-analysis and addresses whether the existing evidence answers the research question. The second part of the framework bears upon how best to use the existing evidence to answer the research question, and the third part addresses how to use the existing evidence to plan future research. Methods: We conducted an online survey among trial statisticians, methodologists and users of evidence synthesis research to capture opinions about all parts of the conditional trial design framework and the practices among clinical researchers. Results: In total, 76 contacted researchers completed the survey. We found that the level of acceptance of network meta-analysis is low to moderate. Three out of four survey participants were willing to consider using evidence synthesis to design a future clinical trial and around half of the participants would give priority to such a trial design. The median rating of the frequency of using it was 0.41 on a scale from 0, which stands for never, to 1, which stands for always.
    [Show full text]