Non-publication of large randomized clinical trials: cross sectional analysis

Objective To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public.Design Cross sectional analysisSetting Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and co...

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Vydané v:BMJ (Online) Ročník 347; číslo oct28 9; s. f6104
Hlavní autori: Jones, Christopher W, Handler, Lara, Crowell, Karen E, Keil, Lukas G, Weaver, Mark A, Platts-Mills, Timothy F
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: England British Medical Journal Publishing Group 29.10.2013
BMJ Publishing Group LTD
BMJ Publishing Group Ltd
Predmet:
Access to Information
Bias
Clinical trials
Cross-Sectional Studies
Enrollments
Ethics
Evidence-based medicine
Fines & penalties
Food
Human subjects
Publishing - statistics & numerical data
Randomized Controlled Trials as Topic - statistics & numerical data
Registration
Registries - statistics & numerical data
Reviews
Time Factors
United States > US
ISSN:0959-8138, 1756-1833, 1756-1833
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Popis
Shrnutí:Objective To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public.Design Cross sectional analysisSetting Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009.Data sources PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.Main outcome measures The frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database.Results Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299 763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov.Conclusions Among this group of large clinical trials, non-publication of results was common and the availability of results in the ClinicalTrials.gov database was limited. A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results.
Bibliografia:local:bmj;347/oct28_9/f6104
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ObjectType-Article-1
ObjectType-Evidence Based Healthcare-3
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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ObjectType-Review-3
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ISSN:0959-8138
1756-1833
1756-1833
DOI:10.1136/bmj.f6104