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Availability and Use of Shared Data From Cardiometabolic Clinical Trials.

Abstract：

BACKGROUND:Sharing of patient-level clinical trial data has been widely endorsed. Little is known about how extensively these data have been used for cardiometabolic diseases. We sought to evaluate the availability and use of shared data from cardiometabolic clinical trials. METHODS:We extracted data from ClinicalStudyDataRequest.com, a large, multisponsor data-sharing platform hosting individual patient-level data from completed studies sponsored by 13 pharmaceutical companies. RESULTS:From January 2013 to May 2017, the platform had data from 3374 clinical trials, of which 537 (16%) evaluated cardiometabolic therapeutics (phase 1, 36%; phase 2, 17%; phase 2/3, 1%; phase 3, 42%; phase 4, 4%). They covered 74 therapies and 398 925 patients. Diabetes mellitus (60%) and hypertension (15%) were the most common study topics. Median time from study completion to data availability was 79 months. As of May 2017, ClinicalStudyDataRequest.com had received 318 submitted proposals, of which 163 had signed data-sharing agreements. Thirty of these proposals were related to cardiometabolic therapies and requested data from 79 unique studies (15% of all trials, 29% of phase 3/4 trials). Most (96%) data requesters of cardiometabolic clinical trial data were from academic centers in North America and Western Europe, and half the proposals were unfunded. Most proposals were for secondary hypothesis-generating questions, with only 1 proposed reanalysis of the original study primary hypothesis. To date, 3 peer-reviewed articles have been published after a median of 19 months (9-32 months) from the data-sharing agreement. CONCLUSIONS:Despite availability of data from >500 cardiometabolic trials in a multisponsor data-sharing platform, only 15% of these trials and 29% of phase 3/4 trials have been accessed by investigators thus far, and a negligible minority of analyses have reached publication.

journal_name

Circulation

journal_title

Circulation

authors

Vaduganathan M,Nagarur A,Qamar A,Patel RB,Navar AM,Peterson ED,Bhatt DL,Fonarow GC,Yancy CW,Butler J

doi

10.1161/CIRCULATIONAHA.117.031883

subject

Has Abstract

pub_date

2018-02-27 00:00:00

pages

938-947

issue

eissn

0009-7322

issn

1524-4539

pii

CIRCULATIONAHA.117.031883

journal_volume

137

pub_type

杂志文章

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Availability and Use of Shared Data From Cardiometabolic Clinical Trials.