CLINICAL TRIALS IN FRANCE- AN UNDEREXPLOITED OPPORTUNITY
Author(s)
Mahi L, Mahi I
Axelys Sante Affaires Medicales et Recherche Clinique, Paris, France
Presentation Documents
OBJECTIVES: Despite high-performance infrastructures and recognized expertise, Clinical trials (CT) are declining in France. Health Professionals deplore the burdens of the French administration that leads to a real concern regarding the international scientific competition. In addition patients are reluctant to participate in CT especially after the benfluorex scandale. METHODS: one of the witnesses of the competitiveness of France in CT is the activities among Clinical Investigation Centers (CIC). These are plateforms fully dedicated to clinical and scientific research acting as an interface between INSERM units (Public National Institut of Scientific Research) and CHU (University Hospital). RESULTS: There are 54 CIC in France. They have been created between 1992 and 2009. CICs are located in university hospitals (CHU) dessiminated in the most important regions of the country. The specific needs of CHU and researchers have led to implement several types of CICs: multi-topics (24 CIC-P), Clinical Epidemiology (9 CIC-EC), integrated in biotherapy (11 CIC-BT) and technological innovations (8 CIC-IT). During the last quadrennium, CIC-P supervised about 1000 protocols, of which 2/3 were therapeutic and 1/3 on physiopathology. 25% of protocols conducted in CIC-P were translational in collaboration with INSERM units, 20% were for rare diseases, 35% were funded by industry and 36% by the PHRC (Academic funding). The AP-HP (Academic Hospitals of Paris Area) is the major sponsor in France and one of the first in Europe, with 500 clinical trials enrolling more than 17,000 patients in 2010. Despite this development, the number of CT submissions to ANSM (French Regulatory Agency) decreased from 1,000 in 2008 to 895 in 2012. ANSM approuved 705 protocols in 2012 versus 790 in 2008. CONCLUSIONS: Despite appropriate structures and willingness to encourage scientific production, clinical trails remain underexploited due to different causes which need to be deeply evaluated.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PHP193
Topic
Organizational Practices
Topic Subcategory
Academic & Educational
Disease
Multiple Diseases