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

Availability of Clinical Trial Data From Industry-Sponsored Cardiovascular Trials

Karthik Murugiah  1 , Jessica D Ritchie  2 , Nihar R Desai  1 , Joseph S Ross  3 , Harlan M Krumholz  4
Affiliations

Availability of Clinical Trial Data From Industry-Sponsored Cardiovascular Trials

Karthik Murugiah et al. J Am Heart Assoc. .

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.

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Figures

Figure 1
Figure 1
Trials by year of completion. A histogram of the 60 trials that met our search criteria on ClinicalTrials.gov by year of completion.
See this image and copyright information in PMC

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