Coordinating Center Models Project: A Study of Coordinating Centers in Multicenter Clinical Trials. I. Design and Methods. Part 1

摘要

The Coordinating Center Models Project (CCMP) is a three-year, contract-supported project sponsored by the National Heart, Lung, and Blood Institute (NHLBI). The NHLBI sponsors a number of large multi-center clinical trials, each of which includes in its organization a coordinating center with responsibility for receiving, processing, and storing accumulating study data and performing other coordination functions. Multicenter clinical trials are complex operations expensive to design and carry out. Consequently, the functions of the coordinating center are also complex. Coordinating centers and project offices of ten multicenter clinical trials, all sponsored by institutes of the National Institutes of Health, have participated in the data collection activities and the development and review of suggestions and recommendations emanating from the CCMP. A series of reports from the CCMP is in preparation. This first report deals with the design and methods of the project.