Results of Expert MeetingsThe Data and Safety Monitoring Committee: Some final thoughts☆,☆☆
References (3)
The Coronary Drug Project: monitoring of the data for evidence of adverse or beneficial treatment effects
Contr Clin Trials
(1983)
Cited by (7)
Sodium-Hydrogen Exchange Inhibition by Cariporide to Reduce the Risk of Ischemic Cardiac Events in Patients Undergoing Coronary Artery Bypass Grafting: Results of the EXPEDITION Study
2008, Annals of Thoracic SurgeryCitation Excerpt :The planned sample size of 7,000 assumed a 12% primary event rate at day 5 for the placebo group and a 20% relative risk reduction in the cariporide treatment arm, a two-sided type 1 error rate of 5%, and power approximately 90%. The protocol specified rules for the conduct of the interim analyses by the Data Safety Management Board to allow stopping the study early for overwhelming evidence of efficacy or for futility [10, 11]. Rules for early termination for efficacy required a nominal significance level of 0.00001 with demonstration of reduction in risk for both components of the primary endpoint (death or nonfatal MI by day 5).
Toward protecting the safety of participants in clinical trials
2003, Controlled Clinical TrialsInternational collaboration is feasible in trials for rare conditions: The EURAMOS experience
2009, Cancer Treatment and ResearchIssues in data monitoring and interim analysis of trials
2005, Health Technology AssessmentData monitoring and safety committees and their operations
2003, Obstetrical and Gynecological Survey
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Reprint requests: David L. DeMets, PhD, Department of Statistics and Biostatistics, University of Wisconsin, 600 Highland Ave, K6/446, Madison, WI 53792-4675. E-mail: [email protected]
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Am Heart J 2001;141:548-9.