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Activity Number:
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251
- SPEED: Biopharmaceutical Methods and Application I, Part 2
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Type:
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Contributed
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Date/Time:
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Monday, July 29, 2019 : 2:00 PM to 2:45 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #307607
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Title:
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Umbrella and Platform Trials: Statistical Considerations on Efficiencies and a Case Study
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Author(s):
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Xiaoyun (Nicole) Li* and Cong Chen and Fang Liu and Wen Li
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Companies:
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Merck and Merck & Co., Inc and Merck and Merck
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Keywords:
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platform trials;
umbrella trials;
controlled study;
randomized clinical trials;
clinical trials
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Abstract:
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Traditionally, each treatment is evaluated separately in its own clinical trial for efficacy proof-of-concept. A “platform trial” is a clinical trial with one single master protocol in which multiple treatments are evaluated simultaneously or in a rolling fashion. In this presentation, we will use statistical theory and simulation studies to explore and demonstrate the efficiencies of platform trials from statistical and operational perspectives, for example, the estimate variation due to site selections. We will also discuss designing platform trials with or without control arms. The presentation will end with a case study.
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Authors who are presenting talks have a * after their name.
