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Activity Number: 164 - FDA Adaptive Designs and Master Protocols Guidance for Clinical Trials – Reflection and Outlook
Type: Topic Contributed
Date/Time: Monday, July 29, 2019 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #304545 Presentation
Title: Finding a Balance of Synergy and Flexibility in Master Protocols
Author(s): Melanie Quintana* and Scott Berry
Companies: Berry Consultants and Berry Consultants
Keywords: Adaptive Trials; Master Protocols; Platform Trials; Clinical Trial Design; Bayesian

Platform trials and Master Protocols provide an efficient approach to accelerate drug development in a wide range of therapeutic areas. Within a platform trial, we are focused on a common disease area and interested in investigating numerous current and emerging therapies for the disease of interest. A key aspect of platform trial design is establishing a master protocol with a set of global rules for how patients are treated and what actions will be taken on the different arms/therapies in terms of when success and/or futility will be declared. Concurrently, therapy-specific appendices are established that provide local rules that are unique to that therapy. One main challenge that emerges when designing a platform trial is trying to find a balance between the flexibility that is allowed in the therapy-specific appendices while still maintaining synergy and efficiency across the arms. Through the review of case studies of several platform trials, we will highlight the key features and advantages of platform trials as well as common concerns and challenges.

Authors who are presenting talks have a * after their name.

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