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

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 (<i>P</i> < .001). PRO-CTCAE has had substantial and growing use in oncology trials since its release.

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Publication Details

Journal
Contemporary Clinical Trials Communications
Published
2025-09-02
DOI
https://doi.org/10.1016/j.conctc.2025.101547
Citations
3
Primary Topic
Clinical practice guidelines implementation
Type
article
Field-Weighted Citation Impact
5.64

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article

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

Brenda Ginos, Lauren Rogak, Minji K. Lee, Claire Yee et al.
3 citations
Contemporary Clinical Trials Communications
Clinical practice guidelines implementation
5.64
article

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

Brenda Ginos, Lauren Rogak, Minji K. Lee, Claire Yee, Blake Langlais, Brie N. Noble, Jamie K. Forschmiedt, Gina L. Mazza, Allison Mary Deal, Gita Thanarajasingam, Amylou Constance Dueck, Ethan Basch, Eric A. Meek
article en
3 citations

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 (<i>P</i> < .001). PRO-CTCAE has had substantial and growing use in oncology trials since its release.

Contemporary Clinical Trials CommunicationsVol. 47
University of North Carolina at Chapel Hill (US), University of Minnesota (US), Mayo Clinic in Arizona (US), Mayo Clinic in Florida (US), UNC Lineberger Comprehensive Cancer Center
National Institutes of Health
Openalex Percentile: Top 4%
Clinical practice guidelines implementation
5.64
DOIOpen Access PDFOpenAlex
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