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Breaking New Ground: Data Monitoring in the Coronary Drug Project

  • Paul L. Canner

Abstract

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.

Keywords

Data Monitoring Case Study Approach Coronary Heart Disease Death Coronary Drug Project Niacin Group 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media, Inc. 2006

Authors and Affiliations

  • Paul L. Canner
    • 1
  1. 1.Maryland Medical Research InstituteBaltimore

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