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Article Dans Une Revue BMJ Open Année : 2021

Status, use and impact of sharing individual participant data from clinical trials: a scoping review

Résumé

OBJECTIVES: To explore the impact of data-sharing initiatives on the intent to share data, on actual data sharing, on the use of shared data and on research output and impact of shared data. ELIGIBILITY CRITERIA: All studies investigating data-sharing practices for individual participant data (IPD) from clinical trials. SOURCES OF EVIDENCE: We searched the Medline database, the Cochrane Library, the Science Citation Index Expanded and the Social Sciences Citation Index via Web of Science, and preprints and proceedings of the International Congress on Peer Review and Scientific Publication. In addition, we inspected major clinical trial data-sharing platforms, contacted major journals/publishers, editorial groups and some funders. CHARTING METHODS: Two reviewers independently extracted information on methods and results from resources identified using a standardised questionnaire. A map of the extracted data was constructed and accompanied by a narrative summary for each outcome domain. RESULTS: 93 studies identified in the literature search (published between 2001 and 2020, median: 2018) and 5 from additional information sources were included in the scoping review. Most studies were descriptive and focused on early phases of the data-sharing process. While the willingness to share IPD from clinical trials is extremely high, actual data-sharing rates are suboptimal. A survey of journal data suggests poor to moderate enforcement of the policies by publishers. Metrics provided by platforms suggest that a large majority of data remains unrequested. When requested, the purpose of the reuse is more often secondary analyses and meta-analyses, rarely re-analyses. Finally, studies focused on the real impact of data-sharing were rare and used surrogates such as citation metrics. CONCLUSIONS: There is currently a gap in the evidence base for the impact of IPD sharing, which entails uncertainties in the implementation of current data-sharing policies. High level evidence is needed to assess whether the value of medical research increases with data-sharing practices.
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Dates et versions

hal-03333562 , version 1 (03-09-2021)

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Paternité - Pas d'utilisation commerciale - Pas de modification

Identifiants

Citer

Christian Ohmann, David Moher, Maximilian Siebert, Edith Motschall, Florian Naudet. Status, use and impact of sharing individual participant data from clinical trials: a scoping review. BMJ Open, 2021, 11 (8), pp.e049228. ⟨10.1136/bmjopen-2021-049228⟩. ⟨hal-03333562⟩
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