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Online J Curr Clin Trials. 1993 Jul 31;Doc No 79:[5870 words; 53 paragraphs].

Data monitoring in the cardiac arrhythmia suppression trial.

Author information

  • 1National Heart, Lung, and Blood Institute, Bethesda, MD 20892.

Abstract

OBJECTIVE:

This report discusses practical aspects of data monitoring in a clinical trial which stopped ahead of schedule due to adverse findings.

DESIGN:

A review of the considerations and decisions made by the data-monitoring committee of the Cardiac Arrhythmia Suppression Trial (CAST), a randomized, double-blind clinical trial.

PATIENTS:

CAST consisted of men and women with a recent myocardial infarction, asymptomatic or minimally symptomatic ventricular arrhythmias, and reduced left ventricular ejection fraction.

INTERVENTIONS:

In CAST, 3 antiarrhythmic agents, encainide, flecainide, and moricizine, were compared against placebo.

MAIN OUTCOME MEASURES:

The main outcome measures in CAST were arrhythmic death and total mortality.

RESULTS:

CAST found the 3 agents to be harmful. Encainide and flecainide were stopped first. Subsequently, moricizine was discontinued ahead of schedule.

CONCLUSIONS:

The complexity of the study design and a midcourse protocol modification raise several data-monitoring issues not previously discussed. These include how to handle apparently dramatic yet unexpected results, the need for flexibility in modifying study design and goals, and the conflict between existing study data and both conventional wisdom and medical practice.

PMID:
8306012
[PubMed - indexed for MEDLINE]
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