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Clinical Trial Data-sharing Policies Among Journals, Funding Agencies, Foundations, and Other Professional Organizations: A Scoping Review

Published:November 11, 2022DOI:https://doi.org/10.1016/j.jclinepi.2022.11.009
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      Highlights

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        This scoping review contributes to better understanding the interplay between journals, foundations, funding agencies, and professional organizations’ current data-sharing policies and the commonalities and differences between them.
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        Most articles favor a discussion about the advantages of data-sharing more so than the disadvantages of data sharing.
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        A wide variety of commonalities and differences — such as the lack of standardization between policies, and inadequately addressed details regarding the accessibility of research data —exists in data-sharing policies endorsed by biomedical journals, funding agencies, and other professional organizations.
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        Updates to data-sharing policies should strive to provide clearer and more comprehensive instruction based on existing theoretical frameworks, the further development of accessibility of research data, and inclusion of detailed methods to prevent barriers to data-sharing.
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        It is important to identify and address key factors that contribute to the endorsement of and resistance to data-sharing, and to ameliorate the reproducibility of research results to ensure a solid foundation for safe and effective patient care.

      Abstract

      Objectives

      To identify the similarities and differences in data-sharing policies for clinical trial data that are endorsed by biomedical journals, funding agencies, and other professional organizations. Additionally, to determine the beliefs, and opinions regarding data-sharing policies for clinical trials discussed in articles published in biomedical journals.

      Study Design

      Two searches were conducted, a bibliographic search for published articles that present beliefs, opinions, similarities, and differences regarding policies governing the sharing of clinical trial data. The second search analyzed the gray literature (non-peer-reviewed publications) to identify important data-sharing policies in selected biomedical journals, foundations, funding agencies, and other professional organizations.

      Results

      A total of 471 articles were included after database search and screening, with 45 from the bibliographic search and 426 from the gray literature search. A total of 424 data-sharing policies were included. Fourteen of the 45 published articles from the bibliographic search (31.1%) discussed only advantages specific to data-sharing policies, 27 (27/45; 60%) discussed both advantages and disadvantages, and 4 (4/45; 8.9%) discussed only disadvantages specific. A total of 216 journals (of 270; 80%) specified a data-sharing policy provided by the journal itself. One hundred industry data-sharing policies were included, and 32 (32%) referenced a data-sharing policy on their website. One hundred and thirty-six (42%) organizations (of 327) specified a data-sharing policy.

      Conclusion

      We found many similarities listed as advantages to data-sharing and fewer disadvantages were discussed within the literature. Additionally, we found a wide variety of commonalities and differences — such as the lack of standardization between policies, and inadequately addressed details regarding the accessibility of research data — that exist in data-sharing policies endorsed by biomedical journals, funding agencies, and other professional organizations. Our study may not include information on all data sharing policies and our data is limited to the entities’ descriptions of each policy.

      Abbreviations:

      CADTH (Canadian Agency for Drugs and Technologies in Health), CSDR (Clinical Study Data Request), EMA (European Medicines Agency), EU-PAS (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance Post-Authorisation Study), FAIR principles (Findable, accessible, interoperable, reusable guiding principles for scientific data management and stewardship), FDA (Food and Drug Administration), FDAAA (Food and Drug Administration Amendments Act), ICMJE (International Committee of Medical Journal Editors), IOM (Institute of Medicine), NIH (National Institutes of Health), ODC-SCI (Open Data Commons for Spinal Cord Injury), OSF (Open Science Framework), PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews), RQ (Research Question), SOAR (Supporting Open Access Research), YODA (Yale University Open Data Access), WHO (World Health Organization)
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