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J Am Heart Assoc. 2016 Apr 20;5(4):e003307. doi: 10.1161/JAHA.116.003307.

Availability of Clinical Trial Data From Industry-Sponsored Cardiovascular Trials.

Author information

1
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT.
2
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT.
3
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT Department of Health Policy and Management, Yale School of Public Health, New Haven, CT.
4
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT Department of Health Policy and Management, Yale School of Public Health, New Haven, CT harlan.krumholz@yale.edu.

Abstract

BACKGROUND:

Industry-sponsored clinical trials produce high-quality data sets that can be used by researchers to generate new knowledge. We assessed the availability of individual participant-level data (IPD) from large cardiovascular trials conducted by major pharmaceutical companies and compiled a list of available trials.

METHODS AND RESULTS:

We identified all randomized cardiovascular interventional trials registered on ClinicalTrials.gov with >5000 enrollment, sponsored by 1 of the top 20 pharmaceutical companies by 2014 global sales. Availability of IPD for each trial was ascertained by searching each company's website/data-sharing portal. If availability could not be determined, each company was contacted electronically. Of 60 included trials, IPD are available for 15 trials (25%) consisting of 204 452 patients. IPD are unavailable for 15 trials (25%). Reasons for unavailability were: cosponsor did not agree to make IPD available (4 trials) and trials were not conducted within a specific time (5 trials); for the remaining 6 trials, no specific reason was provided. For 30 trials (50%), availability of IPD could not be definitively determined either because of no response or requirements for a full proposal (23 trials).

CONCLUSIONS:

IPD from 1 in 4 large cardiovascular trials conducted by major pharmaceutical companies are confirmed available to researchers for secondary research, a valuable opportunity to enhance science. However, IPD from 1 in 4 trials are not available, and data availability could not be definitively determined for half of our sample. For several of these trials, companies require a full proposal to determine availability, making use of the IPD by researchers less certain.

KEYWORDS:

data sharing; trials

PMID:
27098969
PMCID:
PMC4859296
DOI:
10.1161/JAHA.116.003307
[Indexed for MEDLINE]
Free PMC Article
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