Adaptive Weight Selection for Time-To-Event Data Under Non-Proportional Hazards.

ABSTRACT: When planning a clinical trial for a time-to-event endpoint, we require an estimated effect size and need to consider the type of effect. Usually, an effect of proportional hazards is assumed with the hazard ratio as the corresponding effect measure. Thus, the standard procedure for survival data is generally based on a single-stage log-rank test. Knowing that the assumption of proportional hazards is often violated and sufficient knowledge to derive reasonable effect sizes is usually unavailable, such an approach is relatively rigid. We introduce a more flexible procedure by combining two methods designed to be more robust in case we have little to no prior knowledge. First, we employ a more flexible adaptive multi-stage design instead of a single-stage design. Second, we apply combinatio

SUBMITTER: Danzer MF 

PROVIDER: S-EPMC11912538 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature