Florence T. Bourgeois, MD, MPH; Srinivas Murthy, MD; Kenneth D. Mandl, MD, MPH
Grant Support: By training grant 5T32HD040128 (Dr. Bourgeois) from the National Institute of Child Health and Human Development and grant 5G08LM009778 (Dr. Mandl) from the National Library of Medicine.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-0087.
Reproducible Research Statement:Study protocol: Not available. Statistical code: Available from Dr. Bourgeois (e-mail, firstname.lastname@example.org). Data set: Primary data are available at ClinicalTrials.gov and PubMed.
Requests for Single Reprints: Florence T. Bourgeois, MD, MPH, Division of Emergency Medicine, Children's Hospital Boston, 300 Longwood Avenue, Boston, MA 02115; e-mail, email@example.com.
Current Author Addresses: Dr. Bourgeois: Division of Emergency Medicine, Children's Hospital Boston, 300 Longwood Avenue, Boston, MA 02115.
Dr. Murthy: Division of Infectious Diseases, Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G 1X9, Canada.
Dr. Mandl: Children's Hospital Informatics Program, Harvard-MIT Division of Health Sciences and Technology, Children's Hospital Boston, 300 Longwood Avenue, Boston, MA 02115.
Author Contributions: Conception and design: F.T. Bourgeois, S. Murthy, K.D. Mandl.
Analysis and interpretation of the data: F.T. Bourgeois, S. Murthy, K.D. Mandl.
Drafting of the article: F.T. Bourgeois, S. Murthy, K.D. Mandl.
Critical revision of the article for important intellectual content: F.T. Bourgeois, S. Murthy, K.D. Mandl.
Final approval of the article: F.T. Bourgeois, S. Murthy, K.D. Mandl.
Statistical expertise: F.T. Bourgeois.
Obtaining of funding: F.T. Bourgeois, K.D. Mandl.
Administrative, technical, or logistic support: S. Murthy.
Collection and assembly of data: F.T. Bourgeois, S. Murthy.
Bourgeois FT, Murthy S, Mandl KD. Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov. Ann Intern Med. 2010;153:158-166. doi: 10.7326/0003-4819-153-3-201008030-00006
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Published: Ann Intern Med. 2010;153(3):158-166.
Clinical trial registries are in widespread use to promote transparency around trials and their results.
To describe characteristics of drug trials listed in ClinicalTrials.gov and examine whether the funding source of these trials is associated with favorable published outcomes.
An observational study of safety and efficacy trials for anticholesteremics, antidepressants, antipsychotics, proton-pump inhibitors, and vasodilators conducted between 2000 and 2006.
ClinicalTrials.gov, a Web-based registry of clinical trials launched in 1999.
Publications resulting from the trials for the 5 drug categories of interest were identified, and data were abstracted on the trial record and publication, including timing of registration, elements of the study design, funding source, publication date, and study outcomes. Assessments were based on the primary funding categories of industry, government agencies, and nonprofit or nonfederal organizations.
Among 546 drug trials, 346 (63%) were primarily funded by industry, 74 (14%) by government sources, and 126 (23%) by nonprofit or nonfederal organizations. Trials funded by industry were more likely to be phase 3 or 4 trials (88.7%; PÂ < 0.001 across groups), to use an active comparator in controlled trials (36.8%; PÂ = 0.010 across groups), to be multicenter (89.0%; PÂ < 0.001 across groups), and to enroll more participants (median sample size, 306 participants; PÂ < 0.001 across groups). Overall, 362 (66.3%) trials had published results. Industry-funded trials reported positive outcomes in 85.4% of publications, compared with 50.0% for government-funded trials and 71.9% for nonprofit or nonfederal organizationâ€“funded trials (PÂ < 0.001). Trials funded by nonprofit or nonfederal sources with industry contributions were also more likely to report positive outcomes than those without industry funding (85.0% vs. 61.2%; PÂ = 0.013). Rates of trial publication within 24 months of study completion ranged from 32.4% among industry-funded trials to 56.2% among nonprofit or nonfederal organizationâ€“funded trials without industry contributions (PÂ = 0.005 across groups).
The publication status of a trial could not always be confirmed, which could result in misclassification. Additional information on study protocols and comprehensive trial results were not available to further explore underlying factors for the association between funding source and outcome reporting.
In this sample of registered drug trials, those funded by industry were less likely to be published within 2 years of study completion and were more likely to report positive outcomes than were trials funded by other sources.
National Library of Medicine and National Institute of Child Health and Human Development, National Institutes of Health.
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