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Review
. 2023 Mar 9;19(3):e1010879.
doi: 10.1371/journal.pcbi.1010879. eCollection 2023 Mar.

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

Claude Pellen  1 , Anne Le Louarn  2 , Gilliosa Spurrier-Bernard  3   4 , Evelyne Decullier  5   6 , Jean-Marie Chrétien  7 , Eric Rosenthal  8 , Gérard Le Goff  9 , David Moher  10 , John P A Ioannidis  11 , Florian Naudet  1   12
Affiliations
Review

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

Claude Pellen et al. PLoS Comput Biol. .

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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. When researchers wishing to share data should implement the 10 rules.
Fig 2
Fig 2. Data-sharing rules crossword.
See this image and copyright information in PMC

References

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