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. 2016 Feb 17:352:i637.
doi: 10.1136/bmj.i637.

Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers

Ruijun Chen  1 , Nihar R Desai  2 , Joseph S Ross  3 , Weiwei Zhang  4 , Katherine H Chau  1 , Brian Wayda  5 , Karthik Murugiah  6 , Daniel Y Lu  7 , Amit Mittal  6 , Harlan M Krumholz  8
Affiliations

Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers

Ruijun Chen et al. BMJ. .

Abstract

Objective: To determine rates of publication and reporting of results within two years for all completed clinical trials registered in ClinicalTrials.gov across leading academic medical centers in the United States.

Design: Cross sectional analysis.

Setting: Academic medical centers in the United States.

Participants: Academic medical centers with 40 or more completed interventional trials registered on ClinicalTrials.gov.

Methods: Using the Aggregate Analysis of ClinicalTrials.gov database and manual review, we identified all interventional clinical trials registered on ClinicalTrials.gov with a primary completion date between October 2007 and September 2010 and with a lead investigator affiliated with an academic medical center.

Main outcome measures: The proportion of trials that disseminated results, defined as publication or reporting of results on ClinicalTrials.gov, overall and within 24 months of study completion.

Results: We identified 4347 interventional clinical trials across 51 academic medical centers. Among the trials, 1005 (23%) enrolled more than 100 patients, 1216 (28%) were double blind, and 2169 (50%) were phase II through IV. Overall, academic medical centers disseminated results for 2892 (66%) trials, with 1560 (35.9%) achieving this within 24 months of study completion. The proportion of clinical trials with results disseminated within 24 months of study completion ranged from 16.2% (6/37) to 55.3% (57/103) across academic medical centers. The proportion of clinical trials published within 24 months of study completion ranged from 10.8% (4/37) to 40.3% (31/77) across academic medical centers, whereas results reporting on ClinicalTrials.gov ranged from 1.6% (2/122) to 40.7% (72/177).

Conclusions: Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: NRD, JSR, and HMK are recipients of a research agreement from Johnson and Johnson (Janssen), through Yale University, to develop methods of clinical trial data sharing, and of contracts from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting. JSR and HMK are recipients of a research agreement from Medtronic, through Yale University, to develop methods of clinical trial data sharing, and of a grant from the Food and Drug Administration to develop methods for post-market surveillance of medical devices. HMK chairs a cardiac scientific advisory board for UnitedHealth.

Figures

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Fig 1 Time to publication of results or results reporting for completed clinical trials across academic institutions. Of 4347 completed clinical trials, this figure excludes those without dissemination of results (n=1455) as well as those with publication date and results reporting date <0 (n=216)
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Fig 2 Rates of dissemination of clinical trial results (publication of results or reporting of results on ClinicalTrials.gov) within 24 months across academic institutions. Of 4347 completed clinical trials, this figure excludes trials without dissemination of results (n=1455) as well as those with publication date and results reporting date <0 (n=216)
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References

    1. Ross JS, Krumholz HM. Ushering in a new era of open science through data sharing: the wall must come down. JAMA 2013;309:1355-6. 10.1001/jama.2013.1299. 23508736. - DOI - PubMed
    1. Krumholz HM, Ross JS, Gross CP, et al. A historic moment for open science: the Yale University Open Data Access project and medtronic. Ann Intern Med 2013;158:910-1. 10.7326/0003-4819-158-12-201306180-00009. 23778908. - DOI - PMC - PubMed
    1. Krumholz HM. Open science and data sharing in clinical research: basing informed decisions on the totality of the evidence. Circ Cardiovasc Qual Outcomes 2012;5:141-2. 10.1161/CIRCOUTCOMES.112.965848. 22438459. - DOI - PubMed
    1. Ross JS, Lehman R, Gross CP. The importance of clinical trial data sharing: toward more open science. Circ Cardiovasc Qual Outcomes 2012;5:238-40. 10.1161/CIRCOUTCOMES.112.965798. 22438465. - DOI - PMC - PubMed
    1. Ioannidis JP. Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA 1998;279:281-6. 10.1001/jama.279.4.281. 9450711. - DOI - PubMed

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