Breaking New Ground: Data Monitoring in the Coronary Drug Project
Arriving at a decision for early termination of a treatment group or of an entire clinical trial, due to either beneficial or adverse results, is a complex process. It may involve, among other things, the need to (1) determine whether the observed treatment differences are likely to represent real effects and are not due to chance; (2) weigh the importance of different response variables, some possibly trending in favor of the treatment and some against it; (3) adjust for differences in distributions of baseline characteristics among the treatment groups; (4) discern possible biases (due to the study not being double-blind) in the medical management of patients or in the diagnosis of events; and (5) evaluate treatment effects in subgroups of the study participants. Experiences from the Coronary Drug Project in making decisions for early termination and for non-termination of treatment groups are described.
KeywordsData Monitoring Case Study Approach Coronary Heart Disease Death Coronary Drug Project Niacin Group
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