PMID: 8582151Oct 1, 1995Paper

Use of cumulative meta-analysis in the design, monitoring, and final analysis of a clinical trial: a case study

Controlled Clinical Trials
W G HendersonG Sethi

Abstract

From 1983 to 1987, the Department of Veterans Affairs (DVA) Cooperative Studies Program (CSP) conducted a multicenter clinical trial (CSP #207) to determine whether four different antiplatelet regimens compared to placebo could prevent the occlusion of grafts following coronary artery bypass surgery. The study showed that all of the active regimens tended to be better than placebo and that the three regimens containing aspirin were statistically significantly better. A cumulative meta-analysis of 12 trials performed shortly before the end of CSP #207 raised the issue as to whether the meta-analysis, if done earlier, would have changed the conduct of the trial. At the start of the planning period, one trail of size n = 37 had been published with a nonsignificant odds ratio (OR) of 0.74 (95% CI: 0.18, 3.12). At the time that CSP # 207 was approved by the DVA Cooperative Studies Evaluation Committee, two trials had been published (cumulative n = 150, OR = 0.44, 95% CI 0.19, 0.99). At the time patient intake started, five trials showed cumulative n = 769, OR = 0.42, 95% CI = 0.26, 0.68. Although the first 6-month CSP #207 progress report showed no treatment effect, by the time of the 12-month review by the Data Monitoring Board (DM...Continue Reading

References

Jul 23, 1992·The New England Journal of Medicine·J LauT C Chalmers
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Sep 1, 1986·Controlled Clinical Trials·R DerSimonian, N Laird
Jan 26, 1984·The New England Journal of Medicine·J H ChesebroF J Puga
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