PMID: 2093629Jan 1, 1990Paper

Healthy volunteers data bank: where and how?

Fundamental & Clinical Pharmacology
Patrice Jaillon

Abstract

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.

Citations

Mar 17, 2011·JAMA : the Journal of the American Medical Association·David B Resnik, Greg Koski
Jun 24, 2016·Translational Research : the Journal of Laboratory and Clinical Medicine·Nut KoonrungsesomboonJuntra Karbwang
Dec 5, 2015·Journal of Clinical Pharmacology·Thomas M ShiovitzDaniel Burch

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