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Activity Number:
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121
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Type:
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Invited
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Date/Time:
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Monday, August 4, 2008 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300063 |
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Title:
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Utility of Bayesian Methods in Early- and Late-Phase Adaptive Design Clinical Trials
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Author(s):
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Sue-Jane Wang*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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10903 New Hampshire Ave, MailStop WO22, Silver Spring, MD, 20993,
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Keywords:
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A&WC ; clinical trial ; early adaptive trial design ; type II error
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Abstract:
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The recent advances in adaptive design methodology for evaluation of an experimental treatment extend from sample size re-estimation based on accumulating interim data to mid-stream adaptation of primary efficacy endpoint, treatment dose/schedule/duration, or responsive patient population in either early and/or late phases controlled trials. There have been various enthusiastic attempts to bring in Bayesian tools in the design stage, the analysis stage, and the inference stage. In this paper presentation, the role and utility of Bayesian methods for early phase drug development versus late phase drug development will be elucidated using typical and novel scenarios. The contrast between decision issues versus inference issues will be highlighted. Implementation issues related to practical usefulness and interpretability will be discussed.
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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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