Sensitivity of adaptive enrichment trial designs to accrual rates, time to outcome measurement, and prognostic variables.

ABSTRACT: Adaptive enrichment designs involve rules for restricting enrollment to a subset of the population during the course of an ongoing trial. This can be used to target those who benefit from the experimental treatment. Trial characteristics such as the accrual rate and the prognostic value of baseline variables are typically unknown when a trial is being planned; these values are typically assumed based on information available before the trial starts. Because of the added complexity in adaptive enrichment designs compared to standard designs, it may be of special concern how sensitive the trial performance is to deviations from assumptions. Through simulation studies, we evaluate the sensitivity of Type I error, power, expected sample size, and trial duration to different design characterist

SUBMITTER: Qian T 

PROVIDER: S-EPMC5898543 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature