Report: The Scientific and Ethical Basis of the Clinical Evaluation of Medicines

Summary

The scientific basis of the clinical evaluation of medicines is well established, and clinical investigators have also given considerable attention to the ethical problems. But of recent years there has been increasing concern with and critcism of the ethics of these procedures. Lawyers, medical doctors and others have expressed the opinion that the randomised controlled therapeutic trial subordinates the rights of the individual to the advantages of society to a degree that can even be “criminal.” Clinical investigators must respond to such criticism, even if it stems only from a few individuals. Therefore, a conference was convened on this topic. The scientific basis of evaluation of medicines in man was reviewed and found to be in accord with the best ethical standards. The objections that have been advanced were considered and were found to be both misconceived and liable to lead to the proliferation of medicines inadequately evaluated for efficacy and safety, to the disadvantage of society.

The meeting was made possible by a grant from Sandoz, Ltd. Basle, Switzerland.

This report is included with the permission of the European Journal of Clinical Pharmacology 18, 129–134 (1980).