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Session 3 Track C - Clinical Practice: DIA Adaptive Design Scientific Working Group Best Practices Team: Objectives and Case Studies
Session Chair(s)
Marilena Bassi, MA
Senior Executive Director, Therapeutic Products Directorate
Health Canada, Canada
Eva Miller, PhD, MS
Independent Biostatistical Consultant
PRA, United States
Members of the DIA Adaptive Design Scientific Working Group Best Practices team are senior statisticians from the FDA and industry who endeavor to identify gaps in implementation of adaptive trials, and promote the broader use of adaptive design by applying best practices.
Adaptive Designs have not grown to be as large a proportion of total clinical trials undertaken as advocates would have hoped. Barriers to adoption include concerns about regulatory acceptance, the time involved in planning, simulations, communications and teamwork, extra considerations for DMCs, and availability of appropriate software for planning, simulations, and implementation.
In this session, representatives from the working group will summarize the committee’s objectives and current practices and evolving issues related to the use of adaptive trials, and consider what went well and what was learned from a number of case studies. The speakers will share successes and best practices for adaptive designs.
Speaker(s)
Goals and Objectives of DIA ADSWG Best Practices Case Studies Subteam and Two Successful Case Studies
Eva Miller, PhD, MS
PRA, United States
Independent Biostatistical Consultant
Adaptive Design Case Studies: Selecting the Best Dose and Adjusting the Sample Size in a Confirmatory Trial
Yannis Jemiai
Cytel, United States
Chief Scientific Officer
Health Canada Perspective of Adaptive Trial Designs
Norman Viner, MD
Health Canada, Canada
Chief, Clinical Trials Division,The Biologics & Genetic Therapies Directorate
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