Experience collecting interim data on mortality: an example from the RALES study
摘要：
p pIntroduction/p pThe Randomized Aldactone Evaluation Study (RALES) randomized 822 patients to receive 25 mg spironolactone daily and 841 to receive placebo. The primary endpoint was death from all causes. Randomization began on March 24, 1995; recruitment was completed on December 31, 1996; follow-up was scheduled to continue through December 31, 1999. Evidence of a sizeable benefit on mortality emerged early in the RALES. The RALES data safety monitoring board (DSMB), which met semiannually throughout the trial, used a prespecified statistical guideline to recommend stopping for efficacy. At the DSMBs request, its meetings were preceded by an endpoint sweep, that is, a census of all participants to confirm their vital status./p pMethods/p pWe used computer simulation to evaluate the effect of the sweeps./p pResults/p pThe sweeps led to an estimated 5 to 8% increase in the number of reported deaths at the fourth and fifth interim analyses. The data crossed the statistical boundary at the fifth interim analysis. If investigators had reported all deaths within the protocol-required 24-h window, the DSMB might have recommended stopping after the fourth interim analysis./p pDiscussion/p pAlthough endpoint sweeps can cause practical problems at the clinical centers, sweeps are very useful if the intervals between patient visits or contact are long or if endpoints require adjudication by committee, reading center, or central laboratory./p pConclusion/p pWe recommend that trials with interim analyses institute active reporting of the primary endpoints and endpoint sweeps./p
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DOI：
10.1186/cvm-2-1-059
被引量：
年份：
2001
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