Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

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.;

For correspondence:- Email: ahutson@buffalo.edu

Published: 17 December 2003

Citation: Hutson AD. A sequential test procedure for monitoring a singular safety and efficacy outcome. Trop J Pharm Res 2003; 2(2):197-206 doi: 10.4314/tjpr.v2i2.2

© 2003 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

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: nterim analysis; safety monitoring; sequential testing.