Document Detail


Research without results: Inadequate public reporting of clinical trial results.
MedLine Citation:
PMID:  22342449     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE: In order to increase transparency in the medical literature, the Food and Drug Administration (FDA) Modernization Act of 1997 and the FDA Amendment Act of 2007 required registration of all "applicable trials" with required "basic results" reporting. We evaluated the rate of compliance with the FDA mandatory results reporting in www.clinicaltrials.gov. METHODS: All completed registered interventional studies that may be subject to FDA regulation, one year prior to required results reporting (October 2006 to September 2007, n=1097) and during the two years after required reporting (October 2007 to September 2008 (07-08), n=2231 and October 2008 to September 2009 (08-09), n=2923). RESULTS: Downloading all 99,315 records from clinicaltrials.gov, we excluded all non-applicable studies. Results reporting increased from 6.8% (n=75) prior to mandatory reporting to 19.1% (n=427, p<.01) in 07-08 and 10.8% (n=316, p<.01) in 08-09. The odds ratio for results reporting using the 06-07 time period as the reference was 3.31 (95% CI 2.54-4.32) for 07-08 and 1.74 (1.33-2.28) for 08-09. Of the 818 trials with results in clinicaltrials.gov, the rate of published articles found decreased from 60% (n=45) in the year prior to required reporting to 33% (n=140, p<.001) for 07-08 and 20% (n=63, p<.001) for 08-09 time period. CONCLUSION: The majority of studies registered in clinicaltrials.gov are not required to report data. Of studies that may be required to report data, compliance with data reporting has improved. The clinicaltrials.gov website is not yet a comprehensive resource for study results.
Authors:
Ravi K Gopal; Traci E Yamashita; Allan V Prochazka
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-2-9
Journal Detail:
Title:  Contemporary clinical trials     Volume:  -     ISSN:  1559-2030     ISO Abbreviation:  -     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-2-27     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101242342     Medline TA:  Contemp Clin Trials     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Published by Elsevier Inc.
Affiliation:
Department of Ambulatory Care, Denver Veterans Affairs Hospital and Department of General Internal Medicine, University of Colorado Denver School of Medicine, United States.
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