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Session 3: Case Study 2: A Case Study of a Hybrid Control Design in Diffuse B-Cell Lymphoma
Session Chair(s)
Satrajit Roychoudhury, PhD
Executive Director, Statistical Research and Innovation
Pfizer, Inc., United States
The Complex Innovative Trial Design (CID) Pilot Meeting Program was initiated by FDA in 2018 to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. Since then, the FDA published five examples including the case by Roche/Genentech completed in 2021. In the presentation, we will introduce the FDA CID pilot program, share our proposed study design, key discussions during the pilot program and learnings. Our proposed ph3 study design involves utilizing both internal and external control data to support the analysis of secondary endpoint overall survival in DLBCL.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Introduce the FDA CID Pilot Program
- Describe our proposed study design
- Share key discussions during the pilot program and learnings
Speaker(s)
Speaker
Herbert Pang, PhD, MBA
Genentech, A Member of the Roche Group, United States
Expert Statistical Scientist