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Master Protocols: New Approaches to Enrolling Hard-to-Find Subjects and Expediting Drug Development
Session Chair(s)
Theresa Crofts Ashton, PHD
Senior Director, Clinical Statistics, GlaxoSmithKline, United States
Master ("umbrella") protocols that have multiple treatment options are being used to optimize enrollment and expedite drug development based on biomarkers/specific disease traits. This session will discuss this approach and the benefits and challenges of these multi-company collaborations.
Learning Objective : Describe the Umbrella concept; Discuss key considerations.
Speaker(s)
Kert Viele, PHD
Director of Research. Senior Statistical Scientist, Berry Consultants, United States
The Use of Statistical Innovation to Increase Efficiency in Difficult-to-Enroll Clinical Trials
Ulrike Lorch, MD, FFPM
Medical Director, Richmond Pharmacology Ltd., United Kingdom
Combined Adaptive Early Phase Trials: From First-Time-in-Human to Proof of Concept in One Protocol
Amy Burd, PHD
Chief Scientific Officer, Eilean Therapeutics, United States
Beat AML: Practicalities and Lessons Learned From the Construct of a 10-Study Leukemia Umbrella Trial
Nicholas Kenny, PHD
Chief Scientific Officer , Syneos Health, United States
Panelist
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