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Statistica Sinica 23 (2013), 1761-1774





SEQUENTIAL ANALYSIS OF THE COX MODEL UNDER

RESPONSE DEPENDENT ALLOCATION


Xiaolong Luo$^1$, Gongjun Xu$^2$ and Zhiliang Ying$^2$


$^1$Celgene Corporation and $^2$Columbia University


Abstract: [#!SellkeSiegmund!#] developed the Brownian approximation to the Cox partial likelihood score as a process of calendar time, laying the foundation for group sequential analysis of survival studies. We extend their results to cover situations in which treatment allocations may depend on observed outcomes. The new development makes use of the entry time and calendar time along with the corresponding $\sigma$-filtrations to handle the natural information accumulation. Large sample properties are established under suitable regularity conditions.



Key words and phrases: Survival analysis, group sequential methods, outcome dependent allocation, proportional hazards regression, clinical trials, staggered entry, Brownian approximation, weak convergence.

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