Proposal for ethical standards in therapeutic trials.

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Abstract
Presented here are the conclusions and recommendations of an interdisciplinary French committee which informally considered the ethical issues involved in clinical trials as they are currently designed and conducted. These drug trials were examined in terms of type of trial, selection of subjects, informed consent, population size and composition, risks and benefits, dosage schedules, and randomization. The committee proposed that trials with low success from the start be reduced, that subjects be selected who have a strong probability of benefit, and that the physician's respect for the individual subject be monitored. To assure that clinical trials balance the interests of patients and society, the report urges the establishment of ethics committees, consisting of two physicians, a statistician, a lawyer, and a judge, to evaluate trial proposals.