Availability and Use of Shared Data From Cardiometabolic Clinical Trials

Abstract

, 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.

Overview and experience of the YODA Project with clinical trial data sharing after 5 years

“…Certain decisions contrast with other existing clinical trial data sharing initiatives (including those found at https://biolincc.nhlbi.nih.gov/studies/ , https://ClinicalStudyDataRequest.com/ , and https://dcri.org , as examples). For instance, the decision to reactively de-identify data for sharing in response to requests has meant that 68% of trials listed on the YODA Project website have been used, as opposed to platforms that have proactively de-identified data for sharing reporting that approximately 15% of listed trials having been used 32 , 33 . Similarly, while the direct, secure data transfer used for Medtronic rhBMP-2 trials was simple, the secure platform used for Johnson & Johnson’s trials is more challenging for investigators, particularly those without advanced statistical expertise.…”

Re-use of trial data in the first 10 years of the data-sharing policy of the Annals of Internal Medicine: a survey of published studies

“…And indeed, there is almost no culture of performing and publishing re-analyses in the clinical trial literature (13), especially by entirely independent authors. Another survey of cardiometabolic clinical trials available on the clinical study data request platform (14) suggested that despite efforts to make data available, re-uses were rare. Over 4 years, only 3 re-uses had been published among the 537 studies available for access.…”

Open science: The open clinical trials data journey

“…The progress in the yield from secondary research in terms of peer-reviewed publications has been cited as being relatively low. 20,39–41 While this could be due to the natural lag in uptake of a relatively new phenomenon, it is in sharp contrast to the resounding cry for openness and availability of data. The jury is still out on the effectiveness of the approaches being taken.…”