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Monday June 15, 2026 2:30pm - 3:30pm EDT
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-539-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Satrajit Roychoudhury, PHD

Speaker

Pooling shared controls in platform trials: operational and statistical considerations
Megan McCabe, PHD

The Art of Borrowing: Practical Strategies to Power Master Protocols
Haitao Chu, MD, PHD

Learnings Across Master Protocols – A Design Perspective
Purvi Prajapti, PHD, MS


Speakers
HC

Haitao Chu

Senior Director, Pfizer, United States
Dr. Haitao Chu is a Senior Director at Pfizer’s Statistical Research and Data Science Center, a role he has held since 2022. He earned his PhD in Biostatistics from Emory University. Dr. Chu has held several academic appointments, including Assistant Professor of Epidemiology at... Read More →
avatar for Megan McCabe

Megan McCabe

Assistant Professor, Department of Biostatistics, The University of Alabama at Birmingham, United States
Megan McCabe is an Assistant Professor in the Department of Biostatistics at the University of Alabama at Birmingham (UAB), and the Assistant Director for Clinical Trials Development for the UAB DATA coordinating and Collaborative Research Unit (DATA CRU). She graduated with her PhD... Read More →
PP

Purvi Prajapati

Sr. Advisor, Eli Lilly, United States
Purvi earned her PhD in Statistics from Baylor University prior to joining Lilly in 2020. Since joining she’s been a member of the Clinical Design Team where she collaborates with multiple study teams to design clinical trials across all phases of drug development across the immunology... Read More →
avatar for Satrajit Roychoudhury

Satrajit Roychoudhury

Executive Director, Statistical Research and Innovation, Pfizer, United States
Dr. Satrajit Roychoudhury is an Executive Director and the head of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and Consulting group at Novartis. His primary expertise includes implementation of innovative statistical... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session

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