Document Detail


The interpretation of clinical trial data--wrongly ACCLAIM'ed?
MedLine Citation:
PMID:  19619687     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Advances in medicine continue to drive forward through the practice of often impressive and innovative investigation. Through the application of randomized clinical trials, statistical analyses deliver the notorious "P values" to provide evidence of whether an intervention results in the desired clinical effect. However, it would appear that it is becoming increasingly common for trial reports to "cheat" the statistical system, particularly when lucrative industrial reward might be at stake. Fortunately, there is a safety net in place for the clinician who is less well accustomed to critiquing the research manuscript. In the United States, the Food and Drug Administration rigorously analyzes evidence relating to safety and efficacy of new therapies before approving them for general use. In Europe, the European Medicines Agency provides a similar service. Yet of much concern, there appears to be clear differences over the respective level of scrutiny of clinical trial data. This article discusses the unease of how a flawed international trial report appeared to deceive the European Union into approving a device-based product for chronic heart failure despite an important lack of credible data.
Authors:
Steven M Shaw; Nizar Yonan; Simon G Williams; James E Fildes
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Publication Detail:
Type:  Editorial    
Journal Detail:
Title:  American heart journal     Volume:  158     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-07-21     Completed Date:  2009-08-21     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  149-51     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Device Approval*
Endpoint Determination
Europe
Heart Failure / immunology,  therapy*
Humans
Randomized Controlled Trials as Topic*
Research Design
United States
United States Food and Drug Administration

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


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