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Implementation of Innovative and Adaptive Designs in Clinical Trials
Session Chair(s)
Aloka Chakravarty, PhD
Director, Data Analytics, Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
The use of innovative designs and possible adaptations can help reduce the number of patients required for trial recruitment, thereby shortening drug development time. Experts from FDA and the industry will provide feedback on the complex innovative designs and how they inform regulatory decision making.
Learning Objective : Outline the advances in adaptive designs; Utilize newly developed innovative designs in clinical trials.
Speaker(s)
Sandra Bihary-Waltz, BSN, MSN
Senior Director, Global Regulatory Affairs, PRA Health Sciences, United States
Recent Advances in Group Sequential and Adaptive Designs for Unblinded Sample Size Re-estimation and Seamless Phase 2/3 Pivotal Trials
Andrew Thomson, PhD, MA, MS
Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
EMA Update
Meiyu Shen, PhD
Expert Mathematical Statistician, Office of Translational Sciences, CDER, FDA, United States
FDA Update
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