The fragility index can be used for sample size calculations in clinical trials.

ABSTRACT:

Objective

The fragility index is a clinically interpretable metric increasingly used to interpret the robustness of clinical trials results that is generally not incorporated in sample size calculation and applied post-hoc. In this manuscript, we propose to base the sample size calculation on the fragility index in a way that supplements the classical prefixed alpha and power cutoffs and we provide a dedicated R software package for the design and analysis tools.

Study design and setting

This approach follows from a novel hypothesis testing framework that is based on the fragility index and builds on the classical testing approach. As case studies, we re-analyse the design of two important trials in cardiovascular medicine, the FAME and FAMOUS-NSTEMI trials.

Results

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SUBMITTER: Baer BR 

PROVIDER: S-EPMC8665025 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature