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[V3-S3] Lessons Learned of Adaptive Design from Case Example
Session Chair(s)
Yasuo Ohashi, PHD
Professor, Dept. of Integrated Science and Engineering for Sustainable Society
Chuo University, Japan
Speaker(s)
An Adaptive, Seamless Phase 2/3 Study Incorporating a Clinical Utility Index
Zachary Kulkarni Skrivanek, PHD
Eli Lilly and Company, United States
Principal Research Scientist, Global Statistical Sciences
Experience of Sample Size Re-estimation for Registration Studies in Japan
Shintaro Hiro, PHD
Pfizer R&D Japan, Japan
Manager, Data Science & Analytics Japan Lead, Clinical Statistics
A Regulatory Perspective on the Use of Adaptive Design in Drug Development
Hiroyuki Sato, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug V