France creates national centre for managing clinical trials

Published: 29-Mar-2007
Regulatory

France is setting up a national centre for managing clinical trials. The centre national de gestion des essais de produits de sante (Cengeps) is intended to 'facilitate the co-ordination and management of industry-sponsored clinical trials carried out in healthcare establishments or networks'.


France is setting up a national centre for managing clinical trials. The centre national de gestion des essais de produits de sante (Cengeps) is intended to 'facilitate the co-ordination and management of industry-sponsored clinical trials carried out in healthcare establishments or networks'.

Its members are the national institute for health and medical research (Inserm), industry body Les entreprises du medicament (Leem) and the various university hospitals throughout France which house interregional clinical research departments (Dirc).

The centre will be formed for four years, and will be based at the Hospices Civils de Lyon. It aims to 'support increasing professionalism and improvement in the quality of industry-sponsored clinical trials with the help of interregional clinical research departments, to improve the management of logistical and administrative aspects of industry-sponsored clinical trials and to maintain France's attractiveness as a place to carry out such trials by ensuring they are carried out with minimal delay'.

The Cengeps is estimated to need an annual budget of e8-10m, according to future director Vincent Diebolt, who is currently head of the research, evaluation, innovation and development division at the French Hospitals Federation (FHF).

Cengeps' funds will be divided up between the Dirc, either annually on the basis of a call for projects or to cover projects lasting several years. The way the funds are used will be monitored and evaluated. Financing will come from pharmaceutical company advertising taxes via the French health products safety agency (Afssaps).

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