Good clinical practices in phase I studies.
In France, official guidelines for good clinical practices in clinical trials were issued in 1987. In December 1988, a law was passed that fixed the requirements for carrying out experiments in healthy subjects. It will be completed by official guidelines for the structures in which experiments on healthy subjects (and patients as well, when the investigation would not benefit the health of the patients) may be conducted. Hence a battery of recent legal instructions precisely state what good clinical practices are in the setting of phase I studies. Of particular importance are: subject recruitment and selection methods and procedures; specific competence of the investigator, in particular to interpret the pre-trial data; necessary and sufficient facilities to guarantee the subjects' safety; careful quality control to check all laboratory procedures; necessity of written standard operating procedures.
Decousus
H
H
Service de Médecine Interne et de Thérapeutique, Hôpital de Bellevue, Saint-Etienne, France.
Perpoint
B
B
Mismetti
P
P
Ollagnier
M
M
Queneau
P
P
D004341:Drug Evaluation / Q000592:standards*; D005602:France; D006801:Humans; D007880:Legislation, Drug / Q000639:trends; D011786:Quality Control