Designing cancer immunotherapy trials with delayed treatment effect using maximin efficiency robust statistics.

ABSTRACT: The indirect mechanism of action of immunotherapy causes a delayed treatment effect, producing delayed separation of survival curves between the treatment groups, and violates the proportional hazards assumption. Therefore using the log-rank test in immunotherapy trial design could result in a severe loss efficiency. Although few statistical methods are available for immunotherapy trial design that incorporates a delayed treatment effect, recently, Ye and Yu proposed the use of a maximin efficiency robust test (MERT) for the trial design. The MERT is a weighted log-rank test that puts less weight on early events and full weight after the delayed period. However, the weight function of the MERT involves an unknown function that has to be estimated from historical data. Here, for simplicity,

SUBMITTER: Ding X 

PROVIDER: S-EPMC9423373 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature