Statistical Fragility of Findings From Randomized Phase 3 Trials in Pediatric Oncology.

ABSTRACT:

Purpose

The fragility index (FI) is an adjunctive metric to facilitate the interpretation of p-values in clinical trials. The FI has not been studied in phase 3 trials in pediatric oncology.

Methods

PubMed was used to identify phase 3 pediatric oncology trials published between 1980 and 2020. We report trial characteristics and calculate the FI for trials with a binary outcome and survival-inferred fragility index (SIFI) for trials with a time-to-event outcome. FI/SIFI is the number of patients from one arm of a trial who would need to change groups for the statistical conclusion to change. We also report fragility quotients (FQ and SFQ) to normalize FI and SIFI relative to trial size.

Results

One hundred and thirteen trials included sufficient data for analysis. The

SUBMITTER: Olsen HE 

PROVIDER: S-EPMC11646933 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature