Evaluating the benefit of clinical trials to future patients.

Large, multicenter clinical trials are expensive to design and to carry out. In spite of the magnitude of expenditures for such endeavors during the past two decades, little attention has been given to evaluating the impact of findings from these trials on those who are expected to benefit from them, i.e., future patients to whom trial findings apply. The implications of failure to demonstrate that results from these large medical experiments have been accepted by medical practitioners and policy makers and applied appropriately to patients must be of concern to all advocates and practitioners of controlled trials. Of the 20 evaluation studies reviewed in this paper, 6 were directed at assessing dollar benefits to the patient or to society. The remaining 14 studies were concerned primarily with physician knowledge and acceptance of trial findings. Investigators and sponsors of each large trial have a responsibility to develop an evaluation strategy during the planning phase of the trial, to publicize findings from the trial, to evaluate the impact of the findings on future patients, to act in response to the results of the evaluation, and to foster integration of findings into patient care policy.