Projet SHARE-CTD (Horizon Europe, appel à projets 2022)
Action : Doctoral Networks
Panel : Life Sciences
Statut du projet : SIGNED

Data from clinical trials are a rich source of clinical information, highly structured and clearly explained by the accompanying protocols. Responsible sharing of such data holds incredible promises to increase value and decrease waste in medical research. It is built on principles (ethical, scientific), governance structures, skills, and operation infrastructure. Clinical trial data sharing (CTDS) is an emerging activity in academia as well as in the pharmaceutical industry. Both communities develop models for organising and performing CTDS. Thereby, several issues gain relevance: enhancing data sharing with researchers, improving public access to clinical study information, sharing results with patients participating in clinical trials, certifying procedures for sharing clinical trial information, and reaffirming commitments to publish clinical trial results. We see a developing field of professional activities that need well educated experts to define and implement best practices. Training such a new generation of experts in CTDS requires specific teachings with a focus on clinical trial transparency and reproducible research practices. It should include topics such as clinical trials regulations, ethical, legal, and social issues, informatics, data science, biostatistics, and meta-research, as well as domain expertise across different medical fields. In order to gain a deep understanding of this developing field, research activities should be based on meta-research approaches. Those activities focus on research on best practices for CTDS, developing methods to make efficient use of shared data (e.g., methods to augment randomised clinical trials, perform independent participant data meta-analysis, or estimate personalised treatment effects) and measuring CTDS impact.

Mots clés : open science, meta research, data sharing

Participants :
- Hôpital universitaire de la Charité de Berlin (Allemagne) — Partner, beneficiary, Enseignement supérieur ou secondaire, subvention : 521078.4 €
- University Medical Center Göttingen (Allemagne) — Partner, beneficiary, Enseignement supérieur ou secondaire, subvention : 260539.2 €
- Ottawa hospital research institute corporation (Canada) — Partner, associated partner, Recherche, subvention : 0.0 €
- Université de Padoue (Italie) — Partner, beneficiary, Enseignement supérieur ou secondaire, subvention : 259437.6 €
- Université Louis-et-Maximilien de Munich (Allemagne) — Coordinator, beneficiary, Enseignement supérieur ou secondaire, subvention : 260539.2 €
- ZB MED - Information Centre for Life Sciences (Allemagne) — Partner, associated partner, Recherche, subvention : 0.0 €
- Université Stanford (Etats-Unis) — Partner, associated partner, Enseignement supérieur ou secondaire, subvention : 0.0 €
- Lyon-I université (France) — Partner, associated partner, Enseignement supérieur ou secondaire, subvention : 0.0 €
- Université Yale (Etats-Unis) — Partner, associated partner, Enseignement supérieur ou secondaire, subvention : 0.0 €
- Institut national de la santé et de la recherche médicale (France) — Partner, associated partner, Recherche, subvention : 0.0 €
- Leibniz-Gemeinschaft (Allemagne) — Partner, associated partner, Recherche, subvention : 0.0 €
- Université de Rennes (France) — Partner, beneficiary, Enseignement supérieur ou secondaire, subvention : 565387.2 €
- Université d'Utrecht (Pays-Bas) — Partner, associated partner, Enseignement supérieur ou secondaire, subvention : 0.0 €
- Smart data analysis and statistics b.v. (Pays-Bas) — Partner, associated partner, Organismes privés (hors enseignement), subvention : 0.0 €
- Bayer (Germany) (Allemagne) — Partner, associated partner, Organismes privés (hors enseignement), subvention : 0.0 €
- University Medical Center Utrecht (Pays-Bas) — Partner, beneficiary, Enseignement supérieur ou secondaire, subvention : 274370.4 €
- Université de médecine de Vienne (Autriche) — Partner, beneficiary, Enseignement supérieur ou secondaire, subvention : 270331.2 €
- Université de Göttingen (Allemagne) — Partner, associated partner, Enseignement supérieur ou secondaire, subvention : 0.0 €
- Université libre d'Amsterdam (Pays-Bas) — Partner, associated partner, Enseignement supérieur ou secondaire, subvention : 0.0 €
- Ecrin european clinical research infrastructure network (France) — Partner, associated partner, Recherche, subvention : 0.0 €
- National Institute for Health and Care Excellence (Royaume-Uni) — Partner, associated partner, Organismes publics (hors enseignement & recherche), subvention : 0.0 €
- Université de Zurich (Suisse) — Partner, associated partner, Enseignement supérieur ou secondaire, subvention : 0.0 €
- Hospices civils de Lyon (France) — Partner, beneficiary, Organismes publics (hors enseignement & recherche), subvention : 282693.6 €
- Scicrunch inc (Etats-Unis) — Partner, associated partner, Organismes privés (hors enseignement), subvention : 0.0 €