[Organisation of clinical research in France: the new missions of inter-regional delegations for clinical research].
The organisation of clinical research in French teaching hospitals has been profoundly modified over the past 15 years. The first call for clinical research projects was made by the Ministry of Health in 1993. This Hospital Program for Clinical Research was created by the public welfare system, a situation unique in Europe and the USA at the time. Every year since 1993, new clinical research projects have been supported through this program. In 2007, more than 14 million euros was provided for clinical research in oncology more than 21 million euros for clinical research in other fields, and more than 11 million euros through interregional grants. Overall, more than 50 million euros will be provided in 2008 to support clinical research with public sponsorship in French teaching hospitals. Major organisational changes were made to support this unprecedented financial effort in favor of clinical research. In each of the 29 French teaching hospitals, a Delegation for Clinical Research (DRC) was created to promote public sponsorship of clinical trials, to monitor these trials, to guarantee that Good Clinical Practices are respected, and to control the financial aspects of research projects. Clinical Research Assistants were recruited by DRC to monitor clinical trials. Clinical Investigation Centers (CIC) were organized in conjunction with teaching hospitals and with the French biomedical research council (INSERM). Today, there are 54 CICs located in 23 teaching hospitals, conducting clinical trials and other research in epidemiology and biotechnology. In May 2005, seven interregional delegations for clinical research (DIRC) were created to coordinate these activities on a regional basis. The aim was to improve scientific collaboration between teaching hospitals in a given region, to organize the training of clinical investigators and technicians, and to support the development of clinical trial monitoring, quality assurance, and pharmacovigilance. A 2006 survey of clinical trials sponsored by the drug industry in France showed that, by comparison to 2004, the number of patients enrolled had fallen. The mean rate of enrolments per investigator was lower than the European average (1.4 patients per month versus 1.7 in Europe as a whole), and the time necessary to organize hospital-based clinical trials was excessive (140 days). Given the globalisation of clinical trials and the increasing competition among countries, these weaknesses could have had deleterious consequences for French investigators and patients. Thus, in 2007, a joint public-private working party created a public interest group called CENGEPS (Centre national de gestion des essais des produits de santé) to provide financial support for DIRC (10 million euros per year for 4 years), derived from a special tax on drugs industry revenue. The objectives were to promote the development of clinical trials of drugs with industrial sponsors in France, to help clinical investigators to participate in these trials, and to increase the patient accrual rate. After a call for projects from each DIRC, grants were distributed to regional offices charged with managing relations with drug companies. Funds were also provided for the recruitment of 150 clinical trial technicians responsible for speeding patient enrolment and for providing clinicians with logistic backup for patient follow-up. National networks of clinical investigators will be created to develop clinical trials in fields such as Alzheimer's disease, other mental illnesses, pediatric drugs, vaccines, AIDS, thromboembolism, etc. Thus, over the last 15 years, the organization of clinical research in France has been completely overhauled. The creation of DIRC will boost interregional cooperation among teaching hospitals and increase the number of clinical trials with both public and private sponsorship. Quality and efficiency will be improved by the increased professionalism of all those involved in clinical trials.
Jaillon
Patrice
P
Pharmacologie, Hôpital Saint-Antoine AP-HP, Paris. patrice.jaillon@upmc.fr
D035843:Biomedical Research / Q000458:organization & administration*; D005602:France; D006784:Hospitals, Teaching; D006801:Humans