Handling death as an intercurrent event in time to recovery analysis in COVID-19 treatment clinical trials.

ABSTRACT: In clinical trials with the objective to evaluate the treatment effect on time to recovery, such as investigational trials on therapies for COVID-19 hospitalized patients, the patients may face a mortality risk that competes with the opportunity to recover (e.g., be discharged from the hospital). Therefore, an appropriate analytical strategy to account for death is particularly important due to its potential impact on the estimation of the treatment effect. To address this challenge, we conducted a thorough evaluation and comparison of nine survival analysis methods with different strategies to account for death, including standard survival analysis methods with different censoring strategies and competing risk analysis methods. We report results of a comprehensive simulation study that em

SUBMITTER: Li H 

PROVIDER: S-EPMC8986229 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature