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

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From: PLoS ONE(Vol. 15, Issue 8)
Publisher: Public Library of Science
Document Type: Report
Length: 5,663 words
Lexile Measure: 1460L

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Author(s): Jeanne Fabiola Gaba 1,2,*, Maximilian Siebert 1,2, Alain Dupuy 2, David Moher 3,4, Florian Naudet 1


Ensuring that the science they fund meets the highest research integrity standards is a key issue for funders involved in clinical research. According to the International Committee of Medical Journal Editors (ICMJE), an influential working group of general medical journal editors, trial data-sharing is an ethical imperative [1] and should therefore be one of their priorities. Data-sharing aims to maximize the benefits that can arise from individual patient data (IPD) by exploring new or unresolved issues from completed trials, by pooling them in large IPD meta-analyses or by re-analyzing the initial trial data [1]. It also ensures "transparency, openness, and reproducibility" [2] and evaluates the risk taken by patients participating in clinical trials.

The G7 clearly calls for open practices in science as one of their top priorities [3] and various calls to action from clinical research stakeholders to data generators, such as pharmaceutical companies, universities, charities, regulatory agencies, have led to the implementation of policies and recommendations to responsibly share clinical trial data [4]. Data-sharing platforms such as Clinical Study Data Request, the Yale University Open Data Access (YODA) Project and Vivli were created to facilitate data-sharing and to ensure that clinical trial data are FAIR (Findable, Accessible, Interoperable and Reusable) [5]. The ICMJE has promoted data-sharing by requiring authors to include a data-sharing statement in published articles and to register a data-sharing plan for any new trial [6]. However, to be effective, these initiatives need to be supported by funders, as they require dedicated resources for data-sharing plans of this nature. Data-sharing is not a panacea; it entails considerable challenges, such as privacy and patient consent, and it implies substantial costs for the preparation of the data [7].

Funders are therefore key players in supporting data-sharing and are expected to provide appropriate guidance and to require best practice from their grant recipients [4]. However, funder policies and attitudes toward data-sharing have rarely been explored. Concerning commercial funders, a prior survey of 23 top pharmaceutical companies in 2016 found that almost all of them (22; 96%) had a policy to share IPD. The proportion was 71% among a less selected sample. The policies were however different [8] and lower proportions were found in a 2019 survey with only 25% of large companies making IPD accessible, a proportion that was slightly improved after communication and feedback to the firms [9]. Concerning non-commercial funders, a 2017 survey on 20 non-commercial funders of health research found that 10 had a data-sharing policy with only 2 requiring IPD sharing [10].

We designed this survey to update the previous ones on two large, representative samples of international commercial and noncommercial funders, and to explore the implementation of funders' data-sharing policies. The aims of this research were to evaluate the percentage of funders with a data-sharing policy, to describe these policies and to assess the compliance of funded RCTs with the existing data-sharing policies in terms of...

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Gale Document Number: GALE|A633048926