Use Of An Open Access Multi-Sponsor Data Sharing Platform In Cardiology

Circulation(2017)

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摘要
Background: Sharing of patient-level clinical trial data has been widely endorsed, yet little is known how extensively these have been utilized in cardiology. Methods: We extracted data from ClinicalStudyDataRequest.com (CSDR), a large, multi-sponsor, open access platform hosting patient-level data from completed studies sponsored by 13 pharmaceutical companies. Results: From January 2013 to May 2017, the platform had data from 3,374 clinical trials of which 537 (16%) were specific to cardiometabolic therapeutics (phase 1 36%; phase 2 17%; phase 2/3 1%; phase 3 42%; phase 4 4%). These covered 74 therapies and 398,925 patients (Figure 1). Diabetes mellitus (60%) and hypertension (15%) were the most common study topics (Figure 2). Median time from study completion to data availability was 79 months. As of March 2017, CSDR had received 305 submitted proposals, of which 154 had signed data sharing agreements. Thirty of these proposals were related to cardiometabolic therapies and requested data from 81 unique...
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Clinical trials
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