Tropical Journal of Pharmaceutical Research
Official Journal of Pharmacotherpy Group
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A sequential test procedure for monitoring a singular safety and efficacy outcome

Alan D. Hutson

University at Buffalo, Department of Statistics, Farber Hall Room 249A, 3435 Main St., Buffalo, NY  14214-3000

Tropical Journal of Pharmaceutical Research 2003; 2(2): 197-206

Abstract  Full Text

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.

^FTo whom correspondence should be addressed:  E-mail: ahutson@buffalo.edu