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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)
Recent Advances in Group Sequential and Adaptive Designs for Unblinded Sample Size Re-estimation and Seamless Phase 2/3 Pivotal Trials
Sandra Bihary-Waltz, BSN, MSN
PRA Health Sciences, United States
Senior Director, Global Regulatory Affairs
EMA Update
Andrew Thomson, PHD, MA, MS
European Medicines Agency, Netherlands
Statistician, Methodology Taskforce
FDA Update
Meiyu Shen, PHD
FDA, United States
Expert Mathematical Statistician, Office of Translational Sciences, CDER
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