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A sequential test procedure for monitoring a singular safety and efficacy outcome


Alan D Hutson

Abstract

In this note we describe a modification of the sequential probability ratio test (SPRT) developed for the purpose of “flagging” a significant increase in the mortality rate of a treatment relative to a control while ensuring that double-blinding and the Type I error for the primary test of efficacy, also based on mortality rates, is not compromised.

Key words: Interim analysis; safety monitoring; sequential testing.

Trop J Pharm Res, December 2003; 2(2): 197-206

Journal Identifiers


eISSN: 1596-9827
print ISSN: 1596-5996