Two-stage group-sequential designs with delayed responses - what is the point of applying corresponding methods?

ABSTRACT:

Background

In group-sequential designs, it is typically assumed that there is no time gap between patient enrollment and outcome measurement in clinical trials. However, in practice, there is usually a lag between the two time points. This can affect the statistical analysis of the data, especially in trials with interim analyses. One approach to address delayed responses has been introduced by Hampson and Jennison (J R Stat Soc Ser B Stat Methodol 75:3-54, 2013), who proposed the use of error-spending stopping boundaries for patient enrollment, followed by critical values to reject the null hypothesis if the stopping boundaries are crossed beforehand. Regarding the choice of a trial design, it is important to consider the efficiency of trial designs, e.g. in terms of the probabili

SUBMITTER: Schuurhuis S 

PROVIDER: S-EPMC11484224 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature