Surgical innovation and its evaluation.

Early clinical trials, observational or randomized, hasten the prompt evaluation of new operations. Early clinical surveillance facilitates the design and implementation of randomized clinical trials when they are necessary. Of equal or greater importance, long-term surveillance of operations allows continuing evaluation when their use becomes widespread. Standards, coordination, review, and funding of the evaluation of new operations we believe should be centralized in a single national agency, for which an Institute of Health Care Assessment might be created. Implementation and regulation of the evaluation we believe should remain at the local or regional level with existing mechanisms and agencies being used, such as institutional human research committees and local health systems agencies.