Performance Status Restriction in Phase III Cancer Clinical Trials.

ABSTRACT:

Background

Patients with good performance status (PS) tend to be favored in randomized clinical trials (RCTs), possibly limiting the generalizability of trial findings. We aimed to characterize trial-related factors associated with the use of PS eligibility criteria and analyze patient accrual breakdown by PS.

Methods

Adult, therapeutic, multiarm phase III cancer-specific RCTs were identified through ClinicalTrials.gov. PS data were extracted from articles. Trials with a PS restriction ECOG score ≤1 were identified. Factors associated with PS restriction were determined, and the use of PS restrictions was analyzed over time.

Results

In total, 600 trials were included and 238,213 patients had PS data. Of those trials, 527 studies (87.8%) specified a PS restriction cuto

SUBMITTER: Abi Jaoude J 

PROVIDER: S-EPMC9671537 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature