A joint initiative of the Agence de l'Innovation en Santé and the F-CRIN Infrastructure to accelerate the evaluation of innovation in healthcare. 31 experts are working on recommendations for use, supported by case studies. This approach includes information for regulatory authorities and a European dimension with participation in ACT-EU and IT Health.
- A joint initiative by Agence Innovation Santé and Infrastructure F-CRIN to accelerate the processes of evaluating healthcare innovation and making it available to patients
- A collective of 31 experts with complementary skills: methodologists; clinician-researchers ; representatives from Inserm, hospitals and the healthcare industry, the Health Data Hub
- Thinking that complements and extends available guidelines, with the aim of practical and operational application
- A three-stage approach with expected deliverables:
- 2023 : Assessment of current situation, hearings; Analysis of practical cases of failures and "success stories", i.e. clinical trials conducted using methodologies other than RCT and having been taken into account for the registration and reimbursement of a health product
- End of 2023: Formulation of recommendations for use (use cases) and definition of acceptability criteria
- 2024: Follow-up of pilot cases selected through a call for expressions of interest with a demonstration objective
- A regular information of regulatory authorities (HAS ; ANSM)
- A European dimension through participation in ACT-EU and IT Health
.
Contact AIS/F-CRIN :
To contact the AIS/F-CRIN mission coordination, leave a message on the contact page, choosing "Mission AIS/F-CRIN" from the "request type" menu.
