Healthy volunteers data bank: where and how?
In order to improve safety for healthy volunteers to be included in phase I clinical trials, a national data bank will be set up and controlled by the French Ministry of Health. Each investigator responsible for an agreed phase I center will have a personal access code to the central computer in order to consult the national registry before including any healthy volunteer in a study. If the volunteer has already participated in a recent study, the investigator will find 2 important pieces of information in the data bank: the duration of the safety period following the preceding trial and during which the subject is not allowed to participate in another study; the total amount of money received by the subject during the last 12 months in grants for phase I studies; this amount will be limited by the Ministry of Health. This healthy volunteer data bank will decrease the risk of drug interaction and will improve safety in phase I trials. However, many practical and ethical problems remain to be solved.
Jaillon
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Unité de Pharmacologie Clinique, Hôpital Saint-Antoine, Paris, France.
D016208:Databases, Factual; D004341:Drug Evaluation / Q000592:standards*; D004992:Ethics, Medical; D005602:France; D006801:Humans; D007880:Legislation, Drug / Q000639:trends; D012107:Research Design