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Activity Number:
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334
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Type:
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Contributed
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Date/Time:
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Tuesday, July 31, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #310014 |
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Title:
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Unweighted versus Weighted Adaptive Design and Its Application in COPD Clinical Trials
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Author(s):
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Peter Zhang*+
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Companies:
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Otsuka Pharmaceutical Development & Commercialization, Inc.
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Address:
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2440 Research Boulevard, Rockville, MD, 20850,
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Keywords:
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adaptive design ; sample size ; interim analysis ; pivotal trials ; COPD ; Unweighted statistics
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Abstract:
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There are many so-called "adaptive design" for early phase proof of concept or dose selection studies. We focus on adaptive design for late phase pivotal trials seeking regulatory approval by FDA or EMEA. Although bio-tech and pharmaceutical companies are very good at to produce "successful" phase 2 trials the failure rate of phase 3 pivotal trials is very high and getting lower. We shows that adaptive design/re-estimating sample size at the interim analysis can short drug development cost and time by reducing the failure rate of Phase 3 trials when the drug is promising. Weighted statistics and Unweighted methods are compared with examples and simulations. An real example of adaptive/design in phase 2/3 pivotal studies in COPD will be provided.
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