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arXiv · 1102.5088

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

Grant Izmirlian
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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.

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Grant Izmirlian. 2011-02-24. Estimation of the relative risk following group sequential procedure based upon the weighted log-rank statistic. https://doi.org/10.4310/sii.2014.v7.n1.a4

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