Invited Speakers

  • Gerhard Hommel (Universitats Mainz) - Keynote speaker
  • Yoav Benjamini (Tel Aviv University) - Southampton Statistical Sciences Research Institute (S3RI) Special Public Lecture
  • Carl-Fredrik Burman (Astra Zeneca)
  • Thorsten Dickhaus (Humboldt-University Berlin)
  • Anthony Hayter (University of Denver)
  • Satoshi Kuriki (The Institute of Statistical Mathematics, Japan)
  • Willi Maurer (Novartis Pharma AG)
  • Cyrus Mehta (Cytel)

Invited sessions

Key subgroup analysis issues in clinical trials (Organized by Alex Dmitrienko)

    Description of session: Analysis of clinical trials with multiple subpopulations defined based on a variety of markers (demographic, clinical and genetic variables) has attracted much attention in the clinical trial community. The U.S. and European regulatory agencies are working on guidance documents on enrichment strategies and subgroup analysis in clinical trials. This session will serve as a forum for presenting new methodologies and discussing key statistical topics in subgroup analysis. The topics will include confirmatory investigation and exploratory analysis of subgroup in controlled trials, benefit-risk analysis, Bayesian and frequentist methods in subgroup analysis, etc. The discussion will be led by subgroup analysis experts from academia, pharmaceutical industry and regulatory agencies. The session will be aimed at a broad audience of statisticians involved in the design and analysis of clinical trials, including statisticians working in the industry, academia and government agencies.

    • James Berger (Duke University)
    • Ilya Lipkovich (Quintiles)
    • Sue-Jane Wang (FDA)

Adaptive designs with multiple objectives (Organized by Olga Marchenko)

  • Nigel Stallard (University of Warwick)
  • Jeffrey Maca (Quintiles)
  • Martin Posch (Medical University of Vienna)

Bayesian FDR (Organized by Dani Yekutieli)

  • Ruth Heller (Tel-Aviv University)
  • Ziv Shkedy (Hasselt University)
  • Annibale Biggeri (University of Florence)

Multiple testing in group sequential trials (Organized by Ajit Tamhane)

  • Ajit Tamhane (Northwestern University)
  • Lingyun Liu (Cytel)
  • David Li (Pfizer)

Selective inference (Organized by Dani Yekutieli)

  • Andreas Buja (University of Pennsylvania)
  • Asaf Weinstein (University of Pennsylvania)
  • Ulrike Schneider (Vienna University of Technology)

Multi-arm multi-stage clinical trials (Organized by Chris Jennison)

  • Chris Jennison (Bath University)
  • James Wason (MRC, Cambridge)
  • Thomas Jaki (University of Lancaster)

Errors in Multiple Testing: Big and Small, More or Less (Organized by Jason Hsu and Frank Bretz)

    Control of (Type I) error rate should translate to control of incorrect decision rate, taking into account the characteristics specific to pharmaceutical drug development. Using aggregate numbers has its limitations. For example, standard FWER control assumes all rejections of true null hypotheses are equally bad, which may be inadequate when the consequences of a larger number of rejections are worse than those of one incorrect rejection or consequences of some incorrect rejections are more serious than those of other rejections. This seems to be the case in situations involving accelerated (conditional) approval, multiple endpoints that are not equally important, and subgroup analyses. The objective of this panel session is to discuss the appropriateness of alternative procedures that take into account the different losses induced by erroneous decisions.

    • Sue-Jane Wang (FDA)
    • Jim Hung (FDA)
    • Martin Posch (Medical University of Vienna)
    • Frank Bretz (Novartis)
    • Jason Hsu (Ohio State University)
    • Willi Maurer (Novartis)
    • Thomas Lang (BASG and AGES, Austria)
    • David Wright (MHRA, UK)
    • James Berger (Duke University)

Open Access to Clinical Trial Data on Patient Level: Opportunities and Challenges (Organized by Martin Posch and Franz Koenig (Medical University of Vienna))

    In the recent months one of the most controversially discussed topics among regulatory agencies, industry, journal editors and academia has been the publication of the raw data of clinical trials. Several projects have been started such as the European Medicines Agency´s (EMA) “proactive publication of clinical trial data“ [1], the BMJ open-data-campaign [2], or the AllTrials initiative [3]. The executive director of the EMA Dr Guido Rasi EMA has recently announced that clinical trial data on patient level shall be published from 2014 onwards. The new EMA policy on proactive access to clinical trial data will be published at the end of June 2013 and open for public consultation until the end of September 2013.

    These initiatives will change the landscape of clinical development and publication of medical research. They provide unprecedented opportunities for research and research synthesis, but pose new challenges for regulatory authorities, sponsors, scientific journals and the public. An important issue in this respect is the interpretation of multiple statistical analyses (both, prospective and retrospective). How can the level of evidence of such multiple analyses be assessed and optimized, e.g., by procedural and analysis guidance?

    The panel discussion will address the role, wishes and needs of the different stakeholders involved.

    Panelists:
    • Sue-Jane Wang [Associate Director,Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA]
    • Dr Trish Groves, (Deputy editor of BMJ and editor of BMJ Open)
    • Thomas Lang [Austrian Agency for Health and Food Safety; Vice Chair of the Biostatistics Working Party at EMA]
    • Simon Day [Clinical Trials Consulting & Training Limited; Former Roche; Former Head of Statistics at MHRA]
    • Peter Bauer [Statistical Advisor of the pediatric committee PDCO at EMA; Medical University of Vienna]
    • Yoav Benjamini (Tel Aviv University)
    • Jim Slattery (the European Medicines Agency)

    [1] http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000555.jsp&mid=WC0b01ac0580607bfa
    [2] http://www.bmj.com/open-data
    [3] http://www.alltrials.net/
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