Author + information
- Received November 14, 2019
- Revision received April 6, 2020
- Accepted April 22, 2020
- Published online June 22, 2020.
- Mitchell A. Psotka, MD, PhDa@mpsotka,
- Federica Latta, MDa,b,
- Dario Cani, MDa,b,
- Mona Fiuzat, PharmDc@mfiuzat,
- Marco Sbolli, MDa,b,
- Scott Barnett, PhDa,
- Marco Metra, MDb and
- Christopher M. O’Connor, MDa,∗ (, )@coconnormd@ihvinews
- aInova Heart and Vascular Institute, Falls Church, Virginia
- bCardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy
- cDepartment of Medicine, Duke University, Durham, North Carolina
- ↵∗Address for correspondence:
Dr. Christopher M. O’Connor, Inova Heart and Vascular Institute, 3300 Gallows Road, Falls Church, Virginia 22042.
Background Under-reporting of clinical trial results inhibits dissemination of knowledge, limits understanding of therapeutic interventions, and may ultimately harm patients.
Objectives This study examined the rates and predictors of heart failure clinical trial publication and how they have changed over time.
Methods This study assessed cross-sectional analysis of all heart failure clinical trials registered on ClinicalTrials.gov with at least 2 years follow-up after trial completion. The content area was chosen for the robust clinical trial activity in the field. The primary outcome was manuscript publication with multivariable proportional hazards adjustment to identify associations with publication.
Results Of the 1,429 included studies, 806 (56%) were published as manuscripts, 623 were unpublished, and 97 (7%) reported results without manuscript publication. Of the total, 1,243 were completed after 2007, when the mean 1-year publication rate for interventional trials rose from 12.7% to 19.6% (p = 0.049), which was possibly associated with changes in government regulation. However, there was no further sustained improvement over time, and there was no multivariable association between later completion dates and reporting or publication of results. Funding from the National Institutes of Health and use of clinical (death, hospitalization, myocardial infarction, changes in functional classification) rather than nonclinical primary endpoints were associated with earlier publication. Whether the results were consistent with the primary study hypothesis was not associated with likelihood of publication.
Conclusions The rates of heart failure clinical trial publication or reporting of results remain unacceptably low. Additional efforts by all stakeholders, including investigators, sponsors, regulators, societies, editors, and journals are needed to improve data dissemination.
Dr. Psotka has received personal fees from Amgen, Cytokinetics, and Windtree. Drs. O’Connor and Fiuzat are editors of JACC: Heart Failure. Dr. Metra is the editor of the European Journal of Heart Failure; has received consultant fees from Abbott, Bayer, Servier, and Vifor; and has received speaker fees from Abbott Vascular and Edwards. Dr. O’Connor has received grant or research support from Roche Diagnostics and Merck; and has received consulting fees from Arena, Bayer, Bristol-Myers Squibb, Merck, and Windtree. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Uri Elkayam, MD, served as Guest Associate Editor and P.K. Shah, MD, served as Guest Editor-in-Chief for this paper.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.
- Received November 14, 2019.
- Revision received April 6, 2020.
- Accepted April 22, 2020.
- 2020 American College of Cardiology Foundation
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