Statistical interim monitoring of the Cardiac Arrhythmia Suppression Trial.

Abstract:

:The Cardiac Arrythmia Suppression Trial was stopped much earlier than planned. Statistical considerations played a very important role in the decision. Flexible group sequential testing was developed for the trial by implementing a Lan and DeMets procedure with use of the permutation test. We compute P-values from the joint permutation distribution of the test statistics, so we do not need to estimate the sampling distribution which in general is rather difficult to do without strict assumptions. The method also gives an exact test for small samples and allows us to use more complicated or non-Gaussian statistics. We also utilized stochastic curtailment ideas to evaluate various scenarios that might occur during the course of the trial, which assisted the Data and Safety Monitoring Board in making appropriate decisions.

journal_name

Stat Med

journal_title

Statistics in medicine

authors

Pawitan Y,Hallstrom A

doi

10.1002/sim.4780090915

subject

Has Abstract

pub_date

1990-09-01 00:00:00

pages

1081-90

issue

9

eissn

0277-6715

issn

1097-0258

journal_volume

9

pub_type

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