Consensus Development: An Historical Note

NIH undertook to examine its possible role in the evaluation of medical technologies 10 years ago, finding that there was no formal structure or forum in either the executive branch of the government or in the private sector for seeking a consensus that a medical innovation was actually safe, beneficial, and ready to be transferred into the health care delivery system.

Abstract

The National Institutes of Health (NIH) has always carefully limited its responsibilities to biomedical research and knowledge development, including clinical trials, dissemination of results of research, and training. Ten years ago, NIH undertook to examine its possible role in the evaluation of medical technologies. In 1976, the U.S. Congress became alarmed over the increase in health care costs: in particular, that a number of expensive technologies, such as coronary artery bypass surgery and electronic fetal monitoring, had entered the delivery system without adequate study of their safety, efficacy, cost, or other implications. At the time, there was no formal structure or forum in either the executive branch of the government or in the private sector for seeking a consensus that a medical innovation was actually safe, beneficial, and ready to be transferred into the health care delivery system. Similarly, there was no structured process through which the parties who comprise the delivery system could meet with representatives of the research community to examine the medical-scientific issues surrounding a given innovation along with cost and cost- effectiveness, ethics, and other societal issues of importance to the system.