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

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.

SUBMITTER: Murugiah K 

PROVIDER: S-EPMC4859296 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature