Attractivité de la France pour les essais cliniques : évaluation par les laboratoires promoteurs

Abstract

Questions have been raised regarding the attractiveness of France versus other countries for performing clinical trials. A questionnaire was sent to pharmaceutical companies with offices in France to assess their level of activity and to get information on the pros and cons of performing phase I-IV international clinical trials in France. Eleven companies, of large to medium size and representing 44% of the shared market returned answers. In 2001, they spent 131 million euros on clinical trials -53% for phase I-III, with a staff of 1469 (not including Contact Research Organisations) -and involved 21 000 investigators recruiting 98 000 patients on local budgets, and 2257 investigators recruiting 10 270 patients on international budgets. France ranked well as regards size of market or resource availability, with an intermediate rank as regards costs, access to patients and disease prevalence, and was weak with regard to speed of recruitment and quality of investigators. Ways of improving France's attractiveness will be discussed.

Optimization of the Inclusion of Alzheimer's Disease Patients in International Multicenter Randomized Trials: Results of a National Survey Conducted in Memory Research Centers in France

“…France has been the second European country behind Scandinavia in terms of recruiting patients (400 patients/million people) for all pathologies [7]. Notably in the field of neuroscience and AD, France has lost this place according to investigations by pharmaceutical companies performed in 2008.…”

Transposition de la Directive Essais Cliniques

“…[3] Les enjeux de cette transposition sont centrés sur la néces-sité de maintenir l'attractivité de la France en tant que territoire d'élection pour mener des essais cliniques, particulièrement continuer à attirer des développements internationaux de médicaments innovants qui permettront au corps médical et aux experts de constituer une expérience personnelle et locale de ces futurs produits. Comme plusieurs enquêtes l'ont montré, [4,5] la loi Huriet-Sérusclat et le principe de notification des essais à l'Afssaps (Agence française de sécurité sanitaire des produits de santé) ont constitué un cadre simple et prévisible pour les essais, favorable à la France. La persistance de différences inter-états sur le projet de transposition peut a contrario être considérée comme une opportunité de consolider cette avance.…”

Adaptation of the Clinical Trials Directive

“…[3] The challenges of this adaptation project focus on the need to maintain the appeal of France as a favourable place for conducting clinical trials, and particularly to continue to attract the international development of innovative medicinal products that will enable the medical community and asssociated experts to develop personal and local experience concerning these future products. As several surveys have shown, [4,5] the HurietSérusclat law and the principle of notifying trials to Afssaps (Agence française de sécurité sanitaire des produits de santé) are part of a simple and predictable framework for trials that favours France. The continued differences between Member States concerning the transposition project may, on the contrary, be considered as an opportunity to consolidate this advance.…”