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Activity Number:
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262
- The FDA Complex Innovative Trial Design Pilot Program: Learning from Case Examples and Simulations for the Public Good
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 4, 2020 : 1:00 PM to 2:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #313865
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Title:
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The Design, Challenges, and Benefits of Evaluating Multiple Assets and Disease Types in a Master Protocol
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Author(s):
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JonDavid Sparks* and Saptarshi Chatterjee and Karen L Price
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Companies:
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Eli Lilly and Company and Eli Lilly and Co and Eli Lilly and Company
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Keywords:
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Master Protocol;
Bayesian;
Hierarchical Modeling
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Abstract:
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A master protocol can efficiently evaluate the safety and efficacy of multiple assets in multiple disease types. During this talk, we provide an overview of a potential design, including both the challenges and opportunities of conducting a master protocol. A key feature of any master protocol is to balance the standardization of design elements where possible, while allowing for flexibility to meet the needs of each asset that may enter the master protocol. The primary statistical model allows for borrowing of key statistical information between assets and pain types, either through pooling of data or through more sophisticated approaches such as Bayesian hierarchical modeling. Pros and cons of various borrowing strategies will be shared and evaluated, with key operating characteristics being compared between strategies.
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Authors who are presenting talks have a * after their name.
