CRISES IN DRUG EVALUATION

Current dilemmas in the clinical evaluation of drugs are partially attributable to the rapid transition from regulations largely limited by individual conscience to a bewildering series of restrictive rules. Although these formalized regulations have been modified to provide more adequate definitions, lack of full understanding of and a certain "built-in illogic" in such requirements have resulted in a sharp decline in drug evaluation. The four parties most intimately concerned with the problems attendant to the study of drugs are: the clinical investigator, the pharmaceutical industry, federal agencies, and the motivating force behind all such study, the patient. Awareness of the need for responsible dialogue concerning the relation of the investigator to these groups prompted the formation of the Fourth Bethesda Conference of the American College of Cardiology. A recent report of the conclusions and recommendations of this conference¹ indicate that the deliberations were concerned with improvement of the environment