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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
Chief Scientific Officer, Eilean Therapeutics, United States
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
Speaker(s)
Donald A Berry, PHD
Professor, Department of Biostatistics, M.D. Anderson Cancer Center, United States
Adaptive Bayesian Platform Trials
Jay Park, PHD, MSC
Scientific Lead and Founder, Core Clinical Sciences, Canada
Master Protocols as a Measure to Improve Healthcare Outcomes in Low- and Middle-Income Countries
Janet Woodcock, MD
Retired, Principal Deputy Commissioner, FDA , United States
Closing Keynote Address
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