Patient selection for clinical trials. Risks versus benefits and quality of life issues

Although some clinician-scientists have expressed reservations regarding utilization of randomized treatment trials, the majority of clinical investigators involved with cancer believe that the well-designed, properly executed clinical trial is the optimal treatment approach if a patient is eligible. To conduct such clinical trials in an ethical fashion, stringent criteria for patient selection are of critical importance both to protect the patient's rights and to assure valid data on outcomes. These selection factors, both ethical and scientific, will be reviewed. Also, the benefits and potential risk factors for participation in the clinical trial that need to be reviewed as part of the informed consent process will be discussed. The cost/benefit ratio should favor participation in the trial, if the trial is properly designed. Quality of life issues, particularly toxicities resulting from one or more treatment alternatives in trial, are an important part of the foregoing analysis. In addition, quality of life endpoints are becoming more important in the planning of clinical treatment trials for cancer, and examples of these will be discussed. In an overall sense, the practical ethics of randomized clinical trials for investigators will be addressed from the standpoint of the impact on potential patient participants.