Intent to share Annals of Internal Medicine’s trial data was not associated with data re-use

Claude Pellen (1, 2) , Laura Caquelin (1, 2) , Alexia Jouvance-Le Bail (1, 2) , Jeanne Gaba (1, 2) , Mathilde Vérin (1, 2) , David Moher (3) , John P A Ioannidis (4) , Florian Naudet (1, 2)

1 CIC - Centre d'Investigation Clinique [Rennes]
2 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
3 OHRI - Ottawa Hospital Research Institute [Ottawa]
4 Stanford University

OBJECTIVE: To explore the impact of the Annals of Internal Medicine (AIM) data-sharing policy for randomized controlled trials (RCTs) in terms of output from data-sharing (i.e. publications re-using the data). STUDY DESIGN AND SETTING: Retrospective study. RCTs published in the AIM between 2007 and 2017 were retrieved on PubMed. Publications where the data had been re-used were identified on Web of Science. Searches were performed by two independent reviewers. The primary outcome was any published re-use of the data (re-analysis, secondary analysis, or meta-analysis of individual participant data [MIPD]), where the first, last and corresponding authors were not among the authors of the RCT. Analyses used Cox (primary analysis) models adjusting for RCTs characteristics (registration: https://osf.io/8pj5e/). RESULTS: 185 RCTs were identified. 106 (57%) mentioned willingness to share data and 79 (43%) did not. 208 secondary analyses, 67 MIPD and no re-analyses were identified. No significant association was found between intent to share and re-use where the first, last and corresponding authors were not among the authors of the primary RCT (adjusted hazard ratio = 1.04 [0.47-2.30]). CONCLUSION: Over ten years, RCTs published in AIM expressing an intention to share data were not associated with more extensive re-use of the data.

Mots clés: Clinical Research; Data sharing; Meta-research; Open science; Randomized Controlled Trial; Re-use of data

Domaines: Sciences du Vivant [q-bio]; Santé publique et épidémiologie

Claude Pellen, Laura Caquelin, Alexia Jouvance-Le Bail, Jeanne Gaba, Mathilde Vérin, et al.. Intent to share Annals of Internal Medicine’s trial data was not associated with data re-use. Journal of Clinical Epidemiology, 2021, 137, pp.241-249. ⟨10.1016/j.jclinepi.2021.04.011⟩. ⟨hal-03222940⟩