Publication of an interministerial report on the importance of communicating the results of clinical trials in France
In the framework of the National Plan for Open Science, the French Ministry of Health and the Ministry of Research set up a working group to develop proposals on how to enhance the transparency of clinical trials, particularly as regards communicating the results of all clinical trials in France. The report by this working group has been approved by the Steering Committee for Open Science, the governance body for Open Science in France.
The transparency of clinical trial results is a core issue for trust and confidence in biomedical research, the quality of patient care and the relevance of public health decisions. In this context, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use came into force in 2022 and established a harmonised legal framework at the European level to help reinforce transparency throughout the life cycle of clinical trials.
A multidisciplinary working group was set up to find out more about the current obstacles to the publication and dissemination of results. The group was also asked to make tangible recommendations to improve compliance with the European regulation. It was made up of representatives of research organisations, academic sponsors of clinical trials, researchers and experts.
The report that has now been published presents the conclusions of this working group. It details the scientific, ethical and budgetary reasons why the results of all completed clinical trials need to be communicated. It also traces the historical process that led to American and European regulations in this area. It uses national indicators to monitor developments in this field in the coming years.
The report also identifies the main levers for improvement and makes operational recommendations designed to support all stakeholders involved in running and supervising clinical trials. The aim of these recommendations is to facilitate the effective implementation of the European regulation while also promoting a culture of transparency for the benefit of research, patients and society as a whole.
The report has been simultaneously published on the websites of both ministries:
- The report on the French Ministry of Higher Education and Research website: www.esr.gouv.fr/rapport-essais-cliniques
- The report on the Ministry of Labour, Health, Solidarity and the Families website: https://sante.gouv.fr/systeme-de-sante/innovation-et-recherche/l-innovation-et-la-recherche-clinique/article/rapport-interministeriel
