IDEAS home Printed from https://ideas.repec.org/a/plo/pcbi00/1010879.html
   My bibliography  Save this article

Ten (not so) simple rules for clinical trial data-sharing

Author

Listed:
  • Claude Pellen
  • Anne Le Louarn
  • Gilliosa Spurrier-Bernard
  • Evelyne Decullier
  • Jean-Marie Chrétien
  • Eric Rosenthal
  • Gérard Le Goff
  • David Moher
  • John P A Ioannidis
  • Florian Naudet

Abstract

Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing:Rule 1: Abide by local legal and regulatory data protection requirementsRule 2: Anticipate the possibility of clinical trial data-sharing before obtaining fundingRule 3: Declare your intent to share data in the registration stepRule 4: Involve research participantsRule 5: Determine the method of data accessRule 6: Remember there are several other elements to shareRule 7: Do not proceed aloneRule 8: Deploy optimal data management to ensure that the data shared is usefulRule 9: Minimize risksRule 10: Strive for excellence.

Suggested Citation

  • Claude Pellen & Anne Le Louarn & Gilliosa Spurrier-Bernard & Evelyne Decullier & Jean-Marie Chrétien & Eric Rosenthal & Gérard Le Goff & David Moher & John P A Ioannidis & Florian Naudet, 2023. "Ten (not so) simple rules for clinical trial data-sharing," PLOS Computational Biology, Public Library of Science, vol. 19(3), pages 1-10, March.
    • Handle: RePEc:plo:pcbi00:1010879
    DOI: 10.1371/journal.pcbi.1010879
    as

    Download full text from publisher

    File URL: https://journals.plos.org/ploscompbiol/article?id=10.1371/journal.pcbi.1010879
    Download Restriction: no
    File URL: https://journals.plos.org/ploscompbiol/article/file?id=10.1371/journal.pcbi.1010879&type=printable
    Download Restriction: no
    File URL: https://libkey.io/10.1371/journal.pcbi.1010879?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:plo:pcbi00:1010879. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: ploscompbiol (email available below). General contact details of provider: https://journals.plos.org/ploscompbiol/ .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.