Extension of a conditional performance score for sample size recalculation rules to the setting of binary endpoints.

ABSTRACT:

Background

Sample size calculation is a central aspect in planning of clinical trials. The sample size is calculated based on parameter assumptions, like the treatment effect and the endpoint's variance. A fundamental problem of this approach is that the true distribution parameters are not known before the trial. Hence, sample size calculation always contains a certain degree of uncertainty, leading to the risk of underpowering or oversizing a trial. One way to cope with this uncertainty are adaptive designs. Adaptive designs allow to adjust the sample size during an interim analysis. There is a large number of such recalculation rules to choose from. To guide the choice of a suitable adaptive design with sample size recalculation, previous literature suggests a conditional perfor

SUBMITTER: Bokelmann B 

PROVIDER: S-EPMC10797857 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature