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Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
ISSN: 1596-5996 EISSN: 1596-5996
Vol. 2, No. 2, 2003, pp. 197-206
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Bioline Code: pr03011
Full paper language: English
Document type: Research Article
Document available free of charge
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Tropical Journal of Pharmaceutical Research, Vol. 2, No. 2, 2003, pp. 197-206
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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.
Keywords
Interim analysis; safety monitoring; sequential testing.
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© Copyright 2003 - Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria. Alternative site location: http://www.tjpr.org
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