Private companies for phase I studies?
In France, the debate is still open regarding where phase I studies should take place. According to its strict definition, very few phase I studies are performed per year in our country. Because they are usually carried out on healthy volunteers, ethics and safety are intimately mixed in with such studies. Safety in these highly specific investigations is founded on 2 bases, first on the independence of the investigator and secondly on the laboratory environment. The economic independence and total lack of responsibility in this respect on the part of the investigator ensure that all ethical considerations including safety are focused on the personal interest of the volunteer who participates in the study.
Lhoste
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F
Service de Pharmacologie Clinique, Hôpital Necker-Enfants Malades, Paris, France.
D004341:Drug Evaluation; D004345:Drug Industry / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions; D004787:Environmental Pollution; D005602:France; D006801:Humans