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Driving Efficiency in Clinical Development with Master Protocols
Session Chair(s)
Satrajit Roychoudhury, PHD
Executive Director, Statistical Research and Innovation
Pfizer, United States
Master protocols are innovative designs for simultaneous evaluation of multiple drug or population under one protocol, enhancing efficiency. Despite their potential, these protocols pose complex scientific, operational, and regulatory challenges.
Learning Objective : Explain the different master protocols (basket, umbrella, platform) in various therapeutic areas; Identify key statistical, operational, and governance challenges; Describe regulatory perspectives and recent guidance; Discuss practical case studies illustrating successes, pitfalls, and innovations.
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