Initiating Clinical Trials: A Case Study of Extracranial-Intracranial Anastomosis

摘要

The case study reviews the major determinants of the National Institute of Neurological and Communicative Disorders and Stroke's decision to initiate and fund a randomized clinical trial (RCT) of extracranial/intracranial (EC/IC) anastomosis on stroke incidence. The report is part of a larger project dealing with RCT decisionmaking at the National Institutes of Health (NIH), which was funded by the National Center for Health Services Research and Health Care Technology Assessment. The step-by-step procedure and rationale of the study are presented, along with a two-factor model of relevance and feasibility. The study was deemed relevant and feasible for several reasons, including the potential importance of EC/IC as a prevention tool, the availability of data collection and analysis resources, and the support of multiple clinical centers for patient recruitment.