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Stat Med. 1990 Mar;9(3):229-35.

A sequential phase II/III trial for binary outcomes.

Author information

1
Department of Statistics, University of Wisconsin, Medical Science Center, Madison 53706.

Abstract

This paper describes a simple two-stage design for randomized clinical trials with a binary outcome. An early stopping criterion applies to results in the experimental arm only and seeks to evaluate that arm with respect to some external standard of efficacy. Stopping rules are similar to those commonly used in phase II designs. This design has no adverse impact on the overall type I error rate, though one must increase sample size to accommodate a modest loss in power.

PMID:
2160719
DOI:
10.1002/sim.4780090305
[Indexed for MEDLINE]

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