Use of patient-reported outcomes version of the common terminology criteria for adverse events in oncology clinical trials.

ABSTRACT: The Patient-Reported Outcomes version of the Common Terminology for Adverse Events® (PRO-CTCAE®) item library enables patient self-reporting of symptoms in cancer clinical trials. It was developed as a companion to CTCAE v4.0. The aim of this analysis is to understand how PRO-CTCAE has been used since its release. Trials using PRO-CTCAE were identified on clinicaltrials.gov. Trial characteristics were descriptively analyzed. Number of trials by year posted on clinicaltrials.gov was tested for increasing trend using Poisson regression. Among 327 identified trials, 318 (97 %) were in oncology, 269 (82 %) were interventional, and 170 (52 %) were randomized. Number of trials significantly increased over time (P < .001). PRO-CTCAE has had substantial and growing use in oncology trials si

SUBMITTER: Rogak L 

PROVIDER: S-EPMC12452844 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature