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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)
The Use of Statistical Innovation to Increase Efficiency in Difficult-to-Enroll Clinical Trials
Kert Viele, PHD
Berry Consultants, United States
Director of Research. Senior Statistical Scientist
Combined Adaptive Early Phase Trials: From First-Time-in-Human to Proof of Concept in One Protocol
Ulrike Lorch, MD, FFPM
Richmond Pharmacology Ltd., United Kingdom
Medical Director
Beat AML: Practicalities and Lessons Learned From the Construct of a 10-Study Leukemia Umbrella Trial
Amy Burd, PHD
Eilean Therapeutics, United States
Chief Scientific Officer
Panelist
Nicholas Kenny, PHD
Syneos Health, United States
Chief Scientific Officer