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Abstract Details
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Activity Number:
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89
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Type:
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Roundtables
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Date/Time:
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Monday, July 30, 2012 : 7:00 AM to 8:15 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305197 |
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Title:
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Phase II Dose-Finding Studies with Rigorous Statistical Designs
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Author(s):
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Lihan Yan*+
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Companies:
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FDA/CBER
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Address:
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1401 Rockville Pike, Rockville, MD, 20852, United States
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Keywords:
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Phase II ;
Dose finding
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Abstract:
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Dose-finding studies are a crucial component in a clinical development program. As Phase II studies, the limited sample size and somewhat relaxed statistical criteria for choosing the optimal dose might result in a suboptimal dose choice under the combined evaluation of safety and effectiveness in the Phase III confirmatory study. This round table will focus discussions on the advantages and disadvantages in designing a Phase II dose-finding study with a rigorous statistical control of the errors. The participants are encouraged to share experiences in planning as well as analyzing Phase II dose-finding studies and its impact on Phase III studies. The discussions will cover topics including multiple comparisons, continual reassessment method and other adaptive dose-finding designs.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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