Initiating Clinical Trials

A Case Study of Extracranial-Intracranial Anastomosis

by Geoffrey M. Anderson, James P. Kahan

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This Note describes the major determinants of the decisions to initiate and to fund a randomized clinical trial of extracranial/intracranial (EC/IC) bypass for stroke prevention. It describes (1) the sources of data; (2) what was known about stroke prevention in 1977; (3) the decision to initiate the EC/IC bypass trial, using a model that suggests relevance and feasibility are important factors in the decision to develop a clinical trial; (4) the peer review of the scientific merit of the grant application and the National Institute of Neurological and Communicative Disorders and Stroke Advisory Council's decision to recommend funding the trial; and (5) conclusions regarding the decisions to initiate and fund clinical trials.

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