Les politiques de partage de données des financeurs d’essais cliniques en France

Pauline Rollando (1) , Céline Parc (2) , Florian Naudet (1) , Jeanne Fabiola Gaba (1, 3)

1 CIC - Centre d'Investigation Clinique [Rennes]
2 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
3 REPERES - Recherche en Pharmaco-épidémiologie et Recours aux Soins

Aims - The aims of this survey were to evaluate the percentage of French clinical trial funders with a data sharing policy, to describe their data sharing policies and, more generally, the transparency of the research they fund. Methods - The different funders of clinical trials in France have been identified from 3 lists of tenders for clinical research projects: the internal list of the University Hospital Center (CHU) of Rennes, the list of the Interregional Group for Clinical Research and Innovation (GIRCI EST), the list of the portal for calls for projects in health research. Funders were contacted, first by email and then by phone (at least two email and/or phone reminders) to respond to an online survey via Google form. The questionnaire aimed to assess the existence of a sharing policy or not, as well as the way in which it was set up. Results - Out of 190 funders contacted, 94 did not respond. Sixty-five of the respondents were excluded because they did not fund clinical trials. Of the 31 funders included (including Direction générale de l'offre de soins [DGOS], Institut national contre le cancer [INCa], Groupement Interrégional de Recherche Clinique et d'Innovation [GIRCIs]), only 9 (29%) had implemented a data sharing policy. Among these nine funders, only one had a mandatory sharing policy and eight a policy supporting but not enforcing data sharing. Five allowed the use of budget lines dedicated to data sharing. Three reported granting data sharing incentives. Three had dedicated guidelines indicating a specific mode of sharing data (sharing on request and/or on a specialized platform) and specifying the type of data (individual patient data and/or protocol and amendments). For all three, there were restrictions on sharing data to researchers only. Data sharing policies concerned 19% of the total financial volume (850,032,000 euros) of the 26 funders who reported this information. Conclusion - Despite international interest in clinical trial data sharing practices, clinical trials funders with a strong data-sharing policy remain an exception in France.

Mots clés: Essai clinique; Partage de données; Transparence de la recherche

Domaines: Sciences du Vivant [q-bio]

Pauline Rollando, Céline Parc, Florian Naudet, Jeanne Fabiola Gaba. Les politiques de partage de données des financeurs d’essais cliniques en France. Therapies, 2020, 75 (6), pp.527-536. ⟨10.1016/j.therap.2020.04.001⟩. ⟨hal-02862266⟩