Clinical trials. Concerns of the patient and the public.

This paper reviews what is known about attitudes toward clinical trials among patients and the public, the use of surrogates (physicians and patients) to determine whether a clinical trial is acceptable, and other empiric data available on this issue. Other concerns related to the conduct of clinical trials are explored including strategies for assuring the best quality of care for patients involved in these studies. The author suggests several actions to improve public understanding and participation in clinical trials including the development of new educational strategies for presenting information to the public, development of mechanisms for documenting and communicating the quality of care received by patients in clinical trials, and the implementation of quality-of-life assessments in clinical trials to provide an additional outcome measure for clinical situations in which the survival differences between treatments are insignificant. The limited information that is available suggests that the concerns of patients and the public must be addressed if clinical trials are to be successful in recruitment of adequate numbers of subjects to answer important clinical research questions.