Reproducibility of statistically significant phase III oncology trials: An In Silico meta-epidemiological analysis.

ABSTRACT:

Purpose

The conventional assumption that P values ≤ 0.05 imply reproducible effects has come under recent criticism. This concern is particularly relevant in oncology, as phase III oncology trials, which directly inform practice, are usually not repeated. Using advanced modeling techniques, we investigated the relationship between P values and reproducibility in oncology.

Methods

We obtained the signal-to-noise ratio distribution in phase III oncology using outcomes from 632 two-arm superiority trials enrolling 496,219 patients. With this distribution, we estimated successful replication probability as the probability that a replicate trial, having the same design, effect size, and standard error, would have a two-sided P ≤ 0.05 and the same effect directionality as the orig

SUBMITTER: Sherry AD 

PROVIDER: S-EPMC12256131 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature