Document Detail


FDA draft guidance on adaptive design clinical trials: Pfizer's perspective.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The Food and Drug Administration of the United States issued a draft guidance on adaptive design clinical trials in February 2010. This draft guidance has attracted a lot of attention because of the increasing interest in adaptive trials by the pharmaceutical industry in recent years. In this paper, we report on highlights of comments collected within Pfizer on this draft guidance.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