Underperformance of Contemporary Phase III Oncology Trials and Strategies for Improvement.

ABSTRACT:

Background

Statistical testing in phase III clinical trials is subject to chance errors, which can lead to false conclusions with substantial clinical and economic consequences for patients and society.

Methods

We collected summary data for the primary endpoints of overall survival (OS) and progression-related survival (PRS) (eg, time to other type of event) for industry-sponsored, randomized, phase III superiority oncology trials from 2008 through 2017. Using an empirical Bayes methodology, we estimated the number of false-positive and false-negative errors in these trials and the errors under alternative P value thresholds and/or sample sizes.

Results

We analyzed 187 OS and 216 PRS endpoints from 362 trials. Among 56 OS endpoints that achieved statistical significan

SUBMITTER: Shen C 

PROVIDER: S-EPMC12788700 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature