Publication and reporting of clinical trial results: cross sectional analysis across academic medical centersBMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i637 (Published 17 February 2016) Cite this as: BMJ 2016;352:i637
- Ruijun Chen, resident physician1,
- Nihar R Desai, assistant professor of medicine2 3,
- Joseph S Ross, associate professor of medicine3 4 5 6,
- Weiwei Zhang, statistician3,
- Katherine H Chau, resident physician1,
- Brian Wayda, resident physician7,
- Karthik Murugiah, cardiology fellow8,
- Daniel Y Lu, resident physician9,
- Amit Mittal, medical student8,
- Harlan M Krumholz, Harold H Hines Jr, professor of medicine and epidemiology and public health2 3 5 6
- 1Department of Medicine, University of California San Francisco, San Francisco, CA, USA
- 2Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA
- 3Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT 06510, USA
- 4Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA
- 5Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA
- 6Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA
- 7Division of General Medicine, Department of Internal Medicine, Columbia University Medical Center, New York, NY, USA
- 8Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA
- 9Department of Medicine, University of Pennsylvania Health System, Philadelphia, PA, USA
- Correspondence to: H M Krumholz
- Accepted 19 January 2016
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.
During the conduct of this work, RC, KHC, BW, and DYL were affiliated with the Department of Internal Medicine, Yale School of Medicine, and KM was affiliated with the Center for Outcomes Research and Evaluation, Yale-New Haven Hospital.
Contributors: RC, NRD, JSR, WZ, and HMK conceived and designed the study. RC, NRD, JSR, KHC, BW, KM, DYL, and AM extracted data and performed the manual review. WZ performed the statistical analyses. RC and NRD drafted the manuscript. All authors interpreted the data, critically revised the manuscript for important intellectual content, and approved the final manuscript. JSR and HMK provided administrative, technical, or material support. RC and NRD are the joint first authors and guarantors.
Funding: This study received no specific funding or grant from any agency in the public, commercial, or not for profit sectors. NRD is supported by the Agency for Healthcare Research and Quality (grant K12 HS023000-01) supports NRD. JSR is supported by the National Institute on Aging (grant K08 AG032886) and by the American Federation for Aging Research through the Paul B Beeson career development award programme. HMK is supported by the National Heart, Lung, and Blood Institute (grant U01 HL105270-05, Center for Cardiovascular Outcomes Research at Yale University). These sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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.
Ethical approval: Not required.
Data sharing: Requests for the statistical code and dataset can be made to the corresponding author (email@example.com). The dataset will be made available through a publicly accessible repository on publication, at the Dryad Digital Repository (datadryad.org).
Transparency: The lead authors (RC, NRD) affirm that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.