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

Autor: Pellen C; Univ Rennes, CHU Rennes, Inserm, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], Rennes, France., Le Louarn A; GCS CNCR (Comité National de Coordination de la Recherche), Paris, France., Spurrier-Bernard G; MelanomeFrance, Teilhet, France.; Melanoma Patient Network Europe, Uppsala, Sweden., Decullier E; Hospices Civils de Lyon, Pôle Santé Publique, Service REC, Lyon, France.; Université de Lyon, Lyon, France., Chrétien JM; CHU Angers, DRI-Département Science de la Donnée, Angers, France., Rosenthal E; ANRS|Maladies infectieuses émergentes, PariSanté Campus, Paris, France., Le Goff G; France Rein Bretagne, Laillé, France., Moher D; Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada., Ioannidis JPA; Departments of Medicine, Epidemiology and Population Health, Biomedical Data Science, and Statistics, and Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, United States of America., Naudet F; Univ Rennes, CHU Rennes, Inserm, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], Rennes, France.; Institut Universitaire de France (IUF), Paris, France.
Jazyk: angličtina
Zdroj: PLoS computational biology [PLoS Comput Biol] 2023 Mar 09; Vol. 19 (3), pp. e1010879. Date of Electronic Publication: 2023 Mar 09 (Print Publication: 2023).
DOI: 10.1371/journal.pcbi.1010879
Abstrakt: 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.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2023 Pellen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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