Document Detail

Exploring changes in treatment effects across design stages in adaptive trials.
MedLine Citation:
PMID:  18381595     Owner:  NLM     Status:  MEDLINE    
The recently published Committee for Medicinal Products for Human Use reflection paper on flexible designs highlights a controversial issue regarding the interpretation of adaptive trials. The guideline suggests that a test for heterogeneity should be preplanned and if treatment effect estimates differ significantly between design stages then data collected before and after the interim analysis might not be combined in a formal analysis. In this paper we investigate error rates for such a procedure in the presence of calendar-time effects. Furthermore, we present an alternative testing strategy based on change point methods. In a simulation study we demonstrate that our procedure performs well in comparison to that suggested by the guideline.
Tim Friede; Robin Henderson
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Pharmaceutical statistics     Volume:  8     ISSN:  1539-1612     ISO Abbreviation:  Pharm Stat     Publication Date:    2009 Jan-Mar
Date Detail:
Created Date:  2009-03-16     Completed Date:  2009-05-20     Revised Date:  2014-02-19    
Medline Journal Info:
Nlm Unique ID:  101201192     Medline TA:  Pharm Stat     Country:  England    
Other Details:
Languages:  eng     Pagination:  62-72     Citation Subset:  IM    
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MeSH Terms
Clinical Trials as Topic / methods*
Computer Simulation
Data Interpretation, Statistical*
Guidelines as Topic
Meta-Analysis as Topic
Research Design
Treatment Outcome
Grant Support
G0400615//Medical Research Council

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

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