Proposal for ethical standards in therapeutic trials.

Abstract

Presented here are the conclusions and recommendations of an\ninterdisciplinary French committee which informally considered the ethical\nissues involved in clinical trials as they are currently designed and\nconducted. These drug trials were examined in terms of type of trial,\nselection of subjects, informed consent, population size and composition,\nrisks and benefits, dosage schedules, and randomization. The committee\nproposed that trials with low success from the start be reduced, that subjects\nbe selected who have a strong probability of benefit, and that the physician's\nrespect for the individual subject be monitored. To assure that clinical\ntrials balance the interests of patients and society, the report urges the\nestablishment of ethics committees, consisting of two physicians, a\nstatistician, a lawyer, and a judge, to evaluate trial proposals. (KIE\nabstract)