Funders' data-sharing policies in therapeutic research: A survey of commercial and non-commercial funders.

Abstract

BackgroundFunders are key players in supporting randomized controlled trial (RCT) data-sharing. This research aimed to describe commercial and non-commercial funders' data-sharing policies and to assess the compliance of funded RCTs with the existing data-sharing policies.Methods and findingsFunders of clinical research having funded at least one RCT in the years 2016 to 2018 were surveyed. All 78 eligible non-commercial funders retrieved from the Sherpa/Juliet Initiative website and a random sample of 100 commercial funders selected from pharmaceutical association member lists (LEEM, IFPMA, EFPIA) and the top 100 pharmaceutical companies in terms of drug sales were included. Thirty (out of 78; 38%) non-commercial funders had a data-sharing policy with eighteen (out of 30, 60%) making data-sharing mandatory and twelve (40%) encouraging data-sharing. Forty-one (out of 100; 41%) of commercial funders had a data-sharing policy. Among funders with a data-sharing policy, a survey of two random samples of 100 RCTs registered on Clinicaltrial.gov, data-sharing statements were present for seventy-seven (77%, 95% IC [67%-84%]) and eighty-one (81% [72% - 88%]) of RCTs funded by non-commercial and commercial funders respectively. Intention to share data was expressed in 12% [7%-20%] and 59% [49%- 69%] of RCTs funded by non-commercial and commercial funders respectively.ConclusionsThis survey identified suboptimal performances of funders in setting up data-sharing policies. For those with a data-sharing policy, the implementation of the policy in study registration was limited for commercial funders and of concern for non-commercial funders. The limitations of the present study include its cross-sectional nature, since data-sharing policies are continuously changing. We call for a standardization of policies with a strong evaluation component to make sure that, when in place, these policies are effective.