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Session 2: Clinical Trial Innovative Designs and Approaches – Setting the Context and Presenting the Industry Perspectives
Session Chair(s)
Michelle A Detry, PhD
Director, Adaptive Trial Execution & Senior Statistical Scientist
Berry Consultants, LLC, United States
Innovation in clinical trials is an ongoing goal with a desired outcome of improving efficiency when investigating new therapies while maintaining the necessary scientific rigor for acceptance in clinical use as well as regulatory approval. Three general areas of innovation are the use of Master Protocols, seamless trial designs, and trials borrowing information from external sources. This session will include one session discussing the use of Master Protocols to obtain trial efficiency, a second session discussing recent design innovations to facilitate efficient learning through seamless phase 2/3 and enrichment designs and the third will discuss the strategy of borrowing information while also presenting design considerations such relevance/comparability of external information and appropriate statistical methods. The session will conclude with audience questions and discussion.
Learning Objective : - Identify the need for improvements in innovation in trial design and conduct
- Summarize in what manner Master Protocols improve efficiency in trial conduct
- Recognize the potential for efficient learning through use of seamless phase 2/3 or enrichment designs
- Evaluate the appropriate use of borrowed information and necessary statistical methods
Speaker(s)
Master Protocols
Elyse Katz, PhD
Tunnell Government Services, Inc., United States
Senior Product Management Support, Warfighter Brain Health PMO, USAMMDA
Recent Design Innovation
Scott Berry, PhD
Berry Consultants LLC, United States
President and Senior Statistical Scientist
Challenges and Opportunities for Borrowing External Data
Satrajit Roychoudhury, PhD
Pfizer, Inc., United States
Executive Director, Statistical Research and Innovation
Challenges and Opportunities for Borrowing External Data
Yun Wang, PhD
FDA, United States
Deputy Division Director, CDER/OTS/OB