Decision to Initiate Clinical Trials of Current Medical Practices

摘要

Investigators reviewed the literature on existing randomized clinical trials (RCT) decision-making practices, interviewed clinical personnel involved in RCTs and policymakers in the Public Health Service, and conducted four RCT case studies to develop a sequential three-stage decision-making model. Several ways in which a current medical practice is questioned and sources of such questions are discussed. These include issues of efficacy and safety, quality of life of patients subjected to the practice, the epidemiological evidence of use. Determining the relevance for an RCT involves evaluation of practical, subjective, political, and methodological aspects. The feasibility of the study also must be assessed, and all technical, philosophical, and policy problems overcome. The model is considered qualitative rather than quantitative. How well it fits the actual NIH decision-making practice is discussed in general, as well as from the standpoint of central policy issues.