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511 * ! Thu, 8/11/2022, 8:30 AM - 10:20 AM CC-207B
In Pursuit of Speed and Efficiency in New Drug Development: Statistical Designs at the Forefront of Pushing the Boundaries of Innovation — Topic Contributed Papers
Biometrics Section, Biopharmaceutical Section, ENAR
Organizer(s): Junjing Lin, Takeda Pharmaceuticals
Chair(s): Margaret Gamalo , Pfizer Inc.
8:35 AM Implications of Using Recurrent Episodes: Statistical Considerations in a Rare Disease Setting
Hengrui Sun, FDA
8:55 AM Incorporating External Information or Real-World Evidence into Adaptive Design with Sample Size Re-Estimation
Ran Liao, Eli Lilly and Company; Junjing Lin, Takeda Pharmaceuticals; Margaret Gamalo , Pfizer Inc.
9:15 AM Design and Analysis of Drop-The-Losers Studies Using Binary Endpoints in the Rare Disease Setting
Ina Jazic, Vertex Pharmaceuticals; Xiaoyan Liu, Vertex Pharmaceuticals; Glen Laird, Vertex Pharmaceuticals
9:35 AM A Bayesian Seamless Design for Phase 2 Early Signals of Efficacy and Dose-Ranging Studies with Historical/Virtual Placebo Controls
Zhen Zhang, Pfizer Inc.; Vivek Pradhan, Pfizer Inc.; Yang Li, Pfizer Inc.
9:55 AM Two-Stage Optimal Designs Based on Exact Variance for a Single-Arm Trial with Survival Endpoints
Guogen Shan, University of Florida
10:15 AM Floor Discussion