Data Monitoring Committees and early stopping guidelines: the Southwest Oncology Group experience.

Data Monitoring Committees in the Southwest Oncology Group comprise the study leadership and the leadership of the Group, augmented by some outside representation. The early stopping guidelines used by these committees are explicit in each protocol, and can be characterized as specifying a few interim analyses at conservative statistical levels. We describe our ten years of experience with this system, and give examples of different trials which have stopped either for positive or negative results.