The Decision to Initiate Clinical Trials of Current Medical Practices

This report examines the decisionmaking process by which the National Institutes of Health (NIH) initiates a randomized clinical trial of a medical practice in current use, i.e., treatment, diagnostic, and preventive practices, including procedures and the use of devices and drugs, that are currently used routinely by some fraction of the practitioner community and are not regarded as experimental. The report's central concern is how NIH decides to initiate clinical trials of the evaluation of problematic current medical practices and how well NIH's approach works. A three-step model describes the NIH decisionmaking process. Each of the three steps — awareness, relevance, and feasibility — is constructed from a number of dimensions. The model suggests three questions of potential policy importance: (1) Does the NIH have a uniform process for deciding whether to initiate clinical trials of current practices? (2) Is there an adequate system for identifying questionable current medical practices? (3) How should clinical trials on questions of the cost effectiveness of medical practices be sponsored?