Authors:
Jean-Baptiste Pretalli
1
;
Stéphanie Py
1
;
Fatimata Seydou Sall
1
;
Magali Nicolier
1
;
Karine Charrière
1
;
Thierry Chevallier
2
;
3
;
4
and
Thomas Lihoreau
2
;
1
;
5
Affiliations:
1
Centre Hospitalier Universitaire de Besançon, Centre d’Investigation Clinique, INSERM CIC 1431, 25030, Besançon, France
;
2
Tech4Health network - FCRIN, France
;
3
Department of Biostatistics, Clinical Epidemiology, Public Health, and Innovation in Methodology, CHU of Nimes, University of Montpellier, Nimes, France
;
4
Desbrest Institute of Epidemiology and Public Health UMR, INSERM - University of Montpellier, Montpellier, France
;
5
Université de Franche-Comté, SINERGIES, F-25000 Besançon, France
Keyword(s):
Medical Devices, Clinical Research, Regulation.
Abstract:
Medical devices must comply with the safety and performance requirements of the European Medical Device Regulation. For clinical investigations, regulatory approval from competent authorities is required. ICTROUVE is a digital tool designed to help identify the clinical investigation’s category when applying to the French competent authority, the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM). We aimed to evaluate ICTROUVE and to prepare a larger-scale study. This pilot study was divided in two sequences. The aim of the first was to recruit experts and to collect study synopses for which the clinical investigation’s category issued by the ANSM was known. To achieve this aim, we created and sent a questionnaire to researchers and regulatory managers via the Tech4Health network. During the second sequence, the experts had to read the synopses and assign them a clinical investigation’s category, first without and then with the help of ICTROUVE. A satisfaction
questionnaire was then completed. We found a low decision agreement between experts and ANSM (39% without ICTROUVE, 51.7% with). ICTROUVE was perceived as useful, easy and quick to use. Information was gathered to facilitate a larger-scale evaluation, notably on the collection of synopses and the search for experts..
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