The therapeutic orientation to clinical trials.

Traditionally, clinical trials have been understood as continuous with clinical medicine. 1 In providing medical care for patients, the physician makes observations, investigates, tests hypotheses, and experiments with different treatments. Moreover, the exemplary physician is always learning how to improve treatment for future patients on the basis of clinical experience with current patients and familiarity with the medical literature. Chalmers summarized this view as follows: “The practice of medicine is in effect the conduct of clinical research. . . . Every practicing physician conducts clinical trials daily as he is seeing patients. The research discipline known as the ‘clinical trial’ is the formalization of this daily process.” 2 From this perspective, both clinical trials and medical care are conceived as scientifically guided, therapeutically oriented activities conducted within the context of the physician–patient relationship. We contend that a therapeutic orientation to clinical trials obscures the ethically significant differences between clinical research and medical care. As a result, it interferes with informed consent and with the development of a concept of professional integrity that is appropriate to clinical research.