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Activity Number:
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77
- Contributed Poster Presentations: Biopharmaceutical Section
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2020 : 10:00 AM to 2:00 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #312795
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Title:
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Evaluation of Type I Error Control for Testing Clinical Endpoint with Pre-Testing Surrogate Endpoint
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Author(s):
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Hsiao-Hui Tsou* and Yu-Chieh Cheng and Hsiao-Yu Wu and Ya-Ting Hsu and Fang-Jing Lee and James Hung
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Companies:
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National Health Research Institutes and National Health Research Institutes and National Health Research Institutes and National Health Research Institutes and National Health Research Institutes and Center for Drug Evaluation and Research, FDA
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Keywords:
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clinical endpoint;
surrogate endpoint;
type I error rate
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Abstract:
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Effectiveness of test medical product is usually based on the clinical endpoint in clinical trials. For some clinical outcomes, clinical trials may or may not be feasible to collect. Use of reasonably likely surrogate endpoints may offer a challenging alternative pathway via accelerated approval, followed by confirmation of benefits based on clinical outcomes within a limited waiting time. The quantitative relationship between the clinical outcomes and the surrogates is a key to support this pathway. In this project we consider a two-stage clinical trial design as a framework for this pathway. We evaluate the statistical operating characteristics for testing the surrogates which requires confirmation on clinical endpoint with high statistical power. Numerical examples and simulation studies will be provided.
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Authors who are presenting talks have a * after their name.
