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Virtual Event

Oct 08, 2020 10:15 AM - Oct 09, 2020 2:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

Master Protocol Workshop

Session 8: Pushing the Boundaries of Master Protocol Studies: Frontiers of Design Innovation and Patient Engagement and Closing Keynote

Session Chair(s)

Amy  Burd, PhD

Amy Burd, PhD

Chief Scientific Officer

Eilean Therapeutics, United States

Kimberly Ann Fisher, MA

Kimberly Ann Fisher, MA

Project Manager for Master Protocol Project

Clinical Trials Transformation Initiative (CTTI), United States

Optimizing the use of master protocol studies will require the clinical trials research community to (1) advance the exploration of new intervention modalities and (2) critically assess strategies to increase the inclusion of patient populations who currently sit at the margins of complex innovative trial design. In a series of lightening round presentations, experts will challenge assumptions about the types of problems and questions master protocol studies can be designed to address. Specific topics will include advancing the exploration of combination therapies and engaging underrepresented patients in the US and low and middle income countries.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe key statistical challenges and problem-solving approaches related to the evaluation of combination therapies in master protocol studies
  • Discuss barriers and strategies for developing master protocol studies to respond to the unmet public health needs of underserved patient populations in the US and low and middle income countries


Donald A Berry, PhD

Adaptive Bayesian Platform Trials

Donald A Berry, PhD

M.D. Anderson Cancer Center, United States

Professor, Department of Biostatistics

Jay  Park, PhD, MSc

Master Protocols as a Measure to Improve Healthcare Outcomes in Low- and Middle-Income Countries

Jay Park, PhD, MSc

Core Clinical Sciences, Canada

Scientific Lead and Founder

Janet  Woodcock, MD

Closing Keynote Address

Janet Woodcock, MD

United States

Retired, Principal Deputy Commissioner, FDA

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