title: [Difficulties with conducting clinical trials in France].
abstract: France ranks third among European countries as regards the level of investment in clinical R&D and, overall, accounts for a contributive effort proportional to the size of its population and pharmaceutical market respectively. However, there is a trend for phase II and III studies to become proportionally fewer than in the past, while the number of phase IV studies is increasing. In a growing proportion of the mega-trials, which are instrumental for establishing evidence-based practice, French experts, investigators and, even more seriously, French patients, are insufficiently represented. Though studies in France are initiated relatively fast due to a clear regulatory framework and perform equally well as far as quantitative and qualitative factors are concerned, compared with most European countries involved in clinical research the costs incurred per completed patient are higher than those recorded in the other countries. Academic research shares most of these constraints and suffers from a lack of financial and human resources, while it faces additional delays in implementing studies because of longer administrative processes. Given the stakes in play, specific solutions should be implemented to maintain and further develop French competitiveness in clinical R&D. At the patient level, positive perception and awareness of the usefulness and safety of participating in clinical trials need to be emphasized. Education at the school level and using the lay media should be developed. Intervention of institutional and government officials is much needed. Direct patient recruitment should be developed through advertisement and the Internet, as well as within doctors' offices and through collaboration with patients' organizations. Patient information and consent forms should be made much simpler than those imposed within the framework of global studies because of FDA requirements. The French health system discourages the recruitment of patients by investigators who are not the family doctor or the usual care provider. Thus, motivation and education of general practitioners and hospital doctors may be increased by involving them during the trial design phase and in the publication process. Specific administrative solutions, within private or public institutions, need to be developed for investigators who do not personally wish to receive investigation fees. Because of lack of availability, investigators need to be assisted with study nurse services and site management organizations, particularly within hospitals and clinics, using the model of the Clinical Investigation Centres. Networks of clinical investigation centres and of individual investigators need to be created. Implementing these solutions should lead to better implications for and reputation of French clinical research.
authors.affiliation: CIC INSERM-CHU Nancy, France.
authors.forename: F
authors.initials: F
authors.lastname: Zannad
authors.forename: Y
authors.initials: Y
authors.lastname: Plétan
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000706:statistics & numerical data; D017322:Clinical Trials, Phase II as Topic / Q000191:economics / Q000706:statistics & numerical data; D017326:Clinical Trials, Phase III as Topic / Q000191:economics / Q000706:statistics & numerical data; D017327:Clinical Trials, Phase IV as Topic / Q000191:economics / Q000706:statistics & numerical data; D019317:Evidence-Based Medicine; D005602:France; D006801:Humans; D007258:Informed Consent; D015337:Multicenter Studies as Topic / Q000191:economics / Q000706:statistics & numerical data; D010353:Patient Education as Topic; D018579:Patient Selection; D010817:Physician-Patient Relations; D011639:Public Opinion; D012106:Research / Q000458:organization & administration; D012108:Research Personnel; D012449:Safety