A two-step approach for analyzing time to event data under non-proportional hazards
arxiv(2024)
摘要
The log-rank test and the Cox proportional hazards model are commonly used to
compare time-to-event data in clinical trials, as they are most powerful under
proportional hazards. But there is a loss of power if this assumption is
violated, which is the case for some new oncology drugs like immunotherapies.
We consider a two-stage test procedure, in which the weighting of the log-rank
test statistic depends on a pre-test of the proportional hazards assumption.
I.e., depending on the pre-test either the log-rank or an alternative test is
used to compare the survival probabilities. We show that if naively implemented
this can lead to a substantial inflation of the type-I error rate. To address
this, we embed the two-stage test in a permutation test framework to keep the
nominal level alpha. We compare the operating characteristics of the two-stage
test with the log-rank test and other tests by clinical trial simulations.
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