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Viewpoints on the FDA draft adaptive designs guidance from the PhRMA working group.
MedLine Citation:
PMID:  21058107     Owner:  NLM     Status:  In-Process    
Abstract/OtherAbstract:
The US Food and Drug Administration has recently released a draft guidance document on adaptive clinical trials. We comment on the document from the particular perspective of the authors as members of a PhRMA working group on this topic, which has interacted with FDA personnel on adaptive trial issue during recent years. We describe the activities and prior work of our working group, and use this as a basis to discuss the content of the guidance document as it relates to several issues of current relevance, such as data monitoring processes, adaptive dose finding, so-called seamless trial designs, and sample size reestimation.
Authors:
Paul Gallo; Keaven Anderson; Christy Chuang-Stein; Vladimir Dragalin; Brenda Gaydos; Michael Krams; José Pinheiro
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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:  1115-24     Citation Subset:  IM    
Affiliation:
Novartis, East Hanover, New Jersey, USA. paul.gallo@novartis.com
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