Coordinating Center Models Project: A Study of Coordinating Centers in Multicenter Clinical Trials. VI. Phases of a Multicenter Clinical Trial

摘要

Long term multicenter clinical trials involve a wide array of activities which change in focus and order of importance as the trial proceeds from beginning to end. This report contains characterizations of six phases of activity: initial design, protocol development and implementation, patient recruitment, treatment and follow-up, patient closeout, and termination; together these phases cover the entire time course of the trial from inception to completion. Appendices include listings of activities in each of these phases for the trial group as a whole and for the coordinating center in particular. Major problems particularly for the coordinating center, can arise from the separation of responsibilities in the trial phase and from overlap of activities from phase to phase. This paper includes a discussion of these problems and possible ways in which they may be avoided or minimized.