After some forty hearings with players in the clinical research ecosystem, the Ministry of Health and Prevention, in partnership with the Agency for Health Innovation (AIS), is launching work to implement a minimum viable product (MVP) national clinical trial base during the first half of 2023.

France, a European leader in clinical research thanks to a proactive policy of support

With 2,602 clinical trials initiated in 2021, France is very active in the field of clinical research and leads the way among European countries. Moreover, in 2022, France was the leading European country in terms of the number of authorization applications submitted to the European portal for the management of authorizations and ethical opinions relating to clinical trials of medicinal products (CTIS platform ). France's position has been maintained over time and is unique in Europe, supported by a proactive policy undertaken by the Government since 2019, notably through measure 3 of the Innovation santé 2030 plan , to make France "the leading country in Europe on clinical trials."

Improving the inclusion of volunteers in clinical trials in France

This positive assessment of France's leading position should not mask the obstacles to the development of clinical research in France on its territory. One of the challenges identified, which is also shared by other European countries, is that of insufficient recruitment in trials and a lack of visibility of trials underway in France.
The Délégation ministérielle au Numérique en Santé (DNS) was commissioned during the 2nd half of 2022 to conduct a survey of the needs of players in the clinical research ecosystem regarding the inclusion of volunteers in clinical trials. It devised several costed scenarios leading to the launch of experimentation around a national MVP base for clinical trials.

"The work carried out by DNS and DGS to prefigure the national clinical trials database is fully in line with the expectations of industry and academics to accelerate clinical research in France. Indeed, this national database, aimed at boosting the ability to anticipate and the speed of recruitment in a number of medical indications for which clinical trials are still under-efficient, will be a strong asset in terms of competitiveness and attractiveness of the territory to achieve the ambitions set by the Plan Innovation Santé 2030." Franck Mouthon, President of France Biotech and Health Ambassador of France 2030

A vast consultation of over 40 players around a clinical trials platform

La DNS consulted the majority of players involved in the development, evaluation, management, coordination and conduct of clinical trials in France. Forty-four (44) interviews were conducted between August and October 2022 with these players: national and European institutional bodies, patient associations, healthcare professionals and institutions involved in clinical research, private or public sponsors and digital health players. The prefiguration work will focus on four functionalities:

1. Propose an exhaustive database of information on clinical trials from reference registries;
2. Make simplified results available in French via an easy-to-use search engine;
3. Provide a simplified information portal on clinical research;
4. Give access to contacts and information on investigating centers.

"The creation of a national database of clinical trials is a long-standing demand of the associations. Our interest and expectations are therefore particularly strong. Our union wishes to continue to participate in this project and will remain vigilant as to how the work is carried out." Gérard Raymond, President of France AssoSanté

Towards a national clinical trials database open to the public and private ecosystem

Work on an MVP entitled ECLAIRE (Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème) was launched this January 18, 2023. Santé.fr will be the first interface with the national database, with the potential highlighting of certain therapeutic areas according to the public health priorities identified by the Ministry of Health and Prevention.
The national database will be primarily designed to meet the needs of volunteers and their healthcare professionals. It will be a vehicle for transforming citizens' perceptions of clinical research, enabling them to be better included in trials and integrated into a process of sharing scientific knowledge.
Working groups in the construction of the MVP will include patient associations, manufacturers and researchers, around themes such as the user experience on Santé.fr, legal aspects around clinical trial data and the RGPD, validation circuits for simplified information and translated into French as well as the possibility of completing them, and educational elements aimed at volunteers.

"The national clinical trials database project is fully in line with the objectives of France 2030's "Plan innovation santé 2030" healthcare plan, and with AIS's mission to accelerate the development of innovations, for the benefit of patients. Clinical research is the most time-consuming stage in the development cycle of healthcare products: today's innovations stem from fundamental research carried out 20 years ago, and we can and must speed things up to enable patients to benefit from innovative healthcare products as soon as possible. We need to move faster by encouraging new clinical research methodologies, digitizing and decentralizing clinical research, and speeding up patient inclusion in clinical trials. In this respect, the creation of a platform providing access to clinical trials conducted in France and accessible to all stakeholders (start-ups, hospitals, patients, manufacturers) will make a major contribution." Lise Alter, Director of the Agence d'innovation en santé