Estimation of the relative risk following group sequential procedure based upon the weighted log-rank statistic

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Publication:117602

DOI10.4310/SII.2014.V7.N1.A4zbMATH Open1326.62175arXiv1102.5088OpenAlexW3105961798MaRDI QIDQ117602FDOQ117602


Authors: Grant Izmirlian, Grant Izmirlian Edit this on Wikidata


Publication date: 2014

Published in: Statistics and Its Interface (Search for Journal in Brave)

Abstract: In this paper we consider a group sequentially monitored trial on a survival endpoint, monitored using a weighted log-rank (WLR) statistic with deterministic weight function. We introduce a summary statistic in the form of a weighted average logged relative risk and show that if there is no sign change in the instantaneous logged relative risk, there always exists a bijection between the WLR statistic and the weighted average logged relative risk. We show that this bijection can be consistently estimated at each analysis under a suitable shape assumption, for which we have listed two possibilities. We indicate how to derive a design-adjusted p-value and confidence interval and suggest how to apply the bias-correction method. Finally, we document several decisions made in the design of the NLST interim analysis plan and in reporting its results on the primary endpoint.


Full work available at URL: https://arxiv.org/abs/1102.5088




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