Document Detail


Seamless Phase II/III combination study through response adaptive randomization.
MedLine Citation:
PMID:  18027224     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
In clinical trials, multiple doses of a new drug are often tested in a Phase II dose finding study. A promising dose then is chosen for further testing and confirmation of its effectiveness in a Phase III study. Although this approach is pragmatically sound, it is known to be inefficient and unreliable because of the time and resource spent on and the very limited information generated from the Phase II study. In this research, a seamless design based on adaptive patient allocation is proposed to combine the traditional Phase II and Phase III steps to achieve the objectives of dose identification and confirmation at the same time within one study. The control of type I error rate is discussed and simulations show that with the proposed method the type I error rate of the study is controlled, and its efficiency and reliability are greatly improved as compared to the traditional approach.
Authors:
Lin Wang; Lu Cui
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of biopharmaceutical statistics     Volume:  17     ISSN:  1054-3406     ISO Abbreviation:  J Biopharm Stat     Publication Date:  2007  
Date Detail:
Created Date:  2007-11-20     Completed Date:  2008-01-17     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9200436     Medline TA:  J Biopharm Stat     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1177-87     Citation Subset:  IM    
Affiliation:
Biostatistics and Programming, Sanofi Aventis, Bridgewater, New Jersey 08807, USA. lin.wang2@sanofi-aventis.com
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MeSH Terms
Descriptor/Qualifier:
Clinical Trials, Phase II as Topic / methods,  statistics & numerical data*
Clinical Trials, Phase III as Topic / methods,  statistics & numerical data*
Computer Simulation
Humans
Randomized Controlled Trials as Topic / methods,  statistics & numerical data*
Research Design*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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