Cited by 11Research Data Management PracticesAcademic Publishing and Open AccessPharmaceutical industry and healthcare

Clinical trial data-sharing policies among journals, funding agencies, foundations, and other professional organizations: a scoping review

Johnson, Austin L., Anderson, J. Michael, Bouvette, Max, Pinero, Israel, Rauh, Shelby, Johnson, Bradley, Kee, Micah, Heigle, Benjamin +4 more·2023·Journal of Clinical Epidemiology

Abstract

Background and 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.Methods 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.

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Crossref · 10.1016/j.jclinepi.2022.11.009

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  • Concerns about data sharing involve a perceived risk of reidentification of individuals, especially in trials enrolling participants with rare diseases, and inappropriate use of the data by other researchers or groups with a particular agenda can be a barrier to sharing.

    “Concerns about data sharing involve a perceived risk of reidentification of individuals, especially in trials enrolling participants with rare diseases. Also, inappropriate use of the data by other researchers or groups with a particular agenda can be a barrier to sharing.89”

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Authors
Johnson, A. L., Anderson, J. M., Bouvette, M., Pinero, I., Rauh, S., Johnson, B., Kee, M., Heigle, B., Tricco, A. C., Page, M. J., McCall Wright, P., & Vassar, M.
Affiliations
  • The University of Texas Medical Branch at Galveston (US)
  • Oklahoma State University Center for Health Sciences (US)
  • University of Oklahoma (US)
  • St. Michael's Hospital (CA)
  • Monash University (AU)
Venue
Journal of Clinical Epidemiology
Publisher
Elsevier BV
Published
2023-02
Volume
154
Pages
42-55
ISSN
0895-4356 (ISSN-L)
OpenAlex
W4308784182
Cited by
11
References
99
Citations by year
2026: 4 · 2025: 5 · 2024: 2
FWCI
0.22
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Clinical Epidemiology (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health
  • National Institute on Drug Abuse (R15DA049201)
  • Australian Research Council (DE200101618)
Topics
  • Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
  • Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Keywords
clinical trial data sharing, data sharing policy, biomedical journals, research funding agencies, professional associations, research data accessibility, policy standardization, research data management
MeSH terms
Humans, Periodicals as Topic, Publications, Societies, Information Dissemination, Policy

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