[Current practice of drug trials in healthy volunteers].
It is impossible to extrapolate for men the animal's data. Pre-therapeutical studies are a necessity to state precisely in man ADME for a new drug and to confirm pharmacological properties seen in animals. Very often, the only healthy volunteers are useful for Phase 1 studies: The selection of volunteers keeps physical and metabolic status, and psychological motivation. True but restricted information is necessary for "free and informed consent". Rights and duties must be clearly defined in written convention. Financial advantages are in agreement of trouble but not of hazard in the study. The safety is the main point in human studies. That means a safe methodology and a protocol approved by independent ethical committee. The monitoring of these studies must be precisely conducted with many clinical and laboratory examinations. Healthy volunteers studies are required by French Ministry of Health, rejected by medical law, condemned by civil law but covered by legal insurances. In French mind is illicit that is not specifically permitted by law. We need special legislation as we refuse medical and ethical responsibility.
Duchier
J
J
Hôpital de Saint-Cloud et Thérapharm-Recherches, Paris.
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000379:methods*; D004992:Ethics, Medical; D005260:Female; D005602:France; D006801:Humans; D007880:Legislation, Drug; D008297:Male; D008875:Middle Aged; D012306:Risk
Pratique actuelle des essais de médicaments sur volontaires sains.