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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.


Session 3: Master Protocols in the COVID-19 Pandemic and Beyond

Session Chair(s)

Rebecca  Hager, PhD

Rebecca Hager, PhD

  • Mathematical Statistician, Office of Biostatistics, CDER
  • FDA, United States
Cindy  Lu, DrSc, PhD

Cindy Lu, DrSc, PhD

  • Director Biostatistics
  • Biogen, United States
Venkat  Sethuraman, PhD, MBA

Venkat Sethuraman, PhD, MBA

  • Senior Vice President, Global Biometrics and Data Sciences
  • Bristol Myers Squibb, United States
This session will review current design and implementation considerations, practical challenges, regulatory landscape, and perspectives from a patient advocate group on master protocols. The considerations covered in this session applies to various therapeutic areas, though specific considerations will also be presented for COVID-19 master protocols.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Explain the basic concept of master protocol and its applications in the COVID-19 pandemic
  • Discuss the advantages of a master protocol framework and why it is popular in the recent drug development era
  • Discuss some general considerations and challenges in designing and implementing the master protocol framework

    Speaker(s)

    Robert A. Beckman, MD

    Master Protocols: Benefits for Clinical Trial Participants and Patients

    Robert A. Beckman, MD

    • Professor of Oncology, Bioinformatics, and Biomathematics
    • Georgetown University Medical Center, United States
    Martin  Posch, PhD

    Speaker

    Martin Posch, PhD

    • Professor
    • Medical University of Vienna, Austria
    Gregory  Levin, PhD

    Speaker

    Gregory Levin, PhD

    • Deputy Director, DBIII, OB, OTS, CDER
    • FDA, United States