| FDA draft guidance on adaptive design clinical trials: Pfizer's perspective. | |
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MedLine Citation:
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PMID: 21058110 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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The Food and Drug Administration of the United States issued a draft guidance on adaptive design clinical trials in February 2010. This draft guidance has attracted a lot of attention because of the increasing interest in adaptive trials by the pharmaceutical industry in recent years. In this paper, we report on highlights of comments collected within Pfizer on this draft guidance. In addition, we share Pfizer's internal journey to promote efficient trial designs since 2005. Adaptive designs have been part of that journey. |
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Authors:
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Christy Chuang-Stein; Mohan Beltangady |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Journal of biopharmaceutical statistics Volume: 20 ISSN: 1520-5711 ISO Abbreviation: J Biopharm Stat Publication Date: 2010 Nov |
Date Detail:
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Created Date: 2010-11-08 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9200436 Medline TA: J Biopharm Stat Country: England |
Other Details:
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Languages: eng Pagination: 1143-9 Citation Subset: IM |
Affiliation:
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Statistics, Pfizer, Inc., Kalamazoo, Michigan, USA. Christy.j.chuang-stein@pfizer.com |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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