Coordination and management of a large multicenter screening trial: The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial is a large and complex multi-institutional, multifaceted organization with a 20-year horizon. The implementation of the trial began with the creation of an organizational structure that supports strong leadership, cooperation, and effective communication among the trial collaborators including an oper ational framework for the development, review, and pretest of instruments, data collection, and management procedures; the setting of high-quality sta ndards for training of trial staff; and the development of a comprehensive assessment plan for evaluation of all trial activities. This paper describe s the process and methods used in the coordination and management of the PL CO trial. These include the role of the steering committee and its subcommi ttees and working groups, the establishment of regular and ad hoc communica tions among collaborators, the training of screening center coordinators an d examiners, the PLCO manual of operations and procedures, and the developm ent and implementation of a comprehensive quality assurance plan. Control C lin Trials 2000;21:310S-328S (C) Elsevier Science Inc. 2000.