TERMINATION OF CLINICAL-TRIALS - THE BETA-BLOCKER HEART ATTACK TRIAL AND THE HYPERTENSION DETECTION AND FOLLOW-UP PROGRAM EXPERIENCE

The close-out of clinical trials that end ahead of schedule often involves problems that differ from those of trials that end as planned. The Beta-Blocker Heart Attack Trial (BHAT), a double-blind study of 3837 post-myocardial infarction patients, was a multicenter clinical trial that ended early because therapeutic benefit had been demonstrated. The Hypertension Detection and Follow-up Program (HDFP), a randomized unblinded study of 10,940 hypertensive individuals, was a multicenter trial that ended as planned. Using these trials as illustrations, the issues arising in multicenter trials that end ahead of schedule are contrasted to those that arise in trials that end as scheduled. Close-out activities that are discussed include documentation of close-out procedures, release of trial information, preparation of trial participants and staff, ascertaining vital status, continuing patient care, data collection and coding, and publication of trial results. Because of the possibility a study might end early, advance planning for close-out is essential.