ETHICS OF CLINICAL-TRIALS

The modern clinical trial is a form of human experimentation. There is a long history of disregard for individual rights of the patient in t his context, and special attention must be paid to ethical guidelines for these studies. Clinical trials differ in basic ways from clinical practice. Foremost is the introduction of outside interests, beyond th ose of the patient's health, into the doctor-patient therapeutic allia nce. Steps must be taken to protect the interests of the patient when such outside influence exists. Kantian moral theory and the Hippocrati c oath dictate that the physician must respect the individual patient' s rights and hold such interests paramount. These principles ave the b asis for informed consent. Randomization of patients is justified when a condition of equipoise exists. The changing nature of health cave d elivery in the United States introduces new outside interests into the doctor-patient relationship.