CHARACTERIZATION OF PATIENT-REPORTED OUTCOME UTILIZATION AND RESULTS REPORTED IN BREAST CANCER CLINICAL TRIALS REGISTERED ON CLINICALTRIALS.GOV (2020-2024)
Author(s)
Kyungwan Hong, PharmD, PhD, Ankit Gandhi, PharmD;
National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA
National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA
OBJECTIVES: Patient-reported outcomes (PROs) provide valuable information on treatment benefits and harms reported directly by patients and support informed decision-making, particularly in breast cancer. Previous studies of PRO use in breast cancer trials focused on pivotal or industry-sponsored trials and PRO reporting in drug labels. This analysis provides a comprehensive review of PRO use in breast cancer trials registered on ClinicalTrials.gov, including non-pivotal and non-industry-sponsored trials, and PRO reporting in corresponding publications.
METHODS: Drug and biologic trials for treatment or prevention of breast cancer with Study Completion Dates of 1/1/2020 to 12/31/2024 and posted results were identified on ClinicalTrials.gov. Outcome measure fields (as of 11/19/2025) were reviewed to identify PRO use and verified using a clinical outcomes assessment database, eProvide. Publications linked to ClinicalTrials.gov study records were assessed to determine whether PROs reported on ClinicalTrials.gov were also reported in corresponding publications. Both authors extracted data and resolved discrepancies through discussions.
RESULTS: Among 312 breast cancer trials reviewed, 56 (17.9%) reported PROs as trial outcomes on ClinicalTrials.gov. These trials were predominantly industry-sponsored (76.8%; 43/56) and phase 2 (42.9%; 24/56) or 3 (51.8%; 29/56). Only 7 (12.5%) used PROs as primary outcomes, and 25 (44.6%) used ≥2 PRO measures simultaneously. Across the trials, 41 unique PRO measures were reported, with EORTC QLQ-C30 most frequently used to measure global health status/quality of life. After excluding duplicates and publications without trial results, 143 linked publications were reviewed. Through publications, 32 of the 56 trials (57.1%) reported results for 20 of the 41 PRO measures.
CONCLUSIONS: Nearly half of breast cancer trials that included PROs only reported these outcomes on ClinicalTrials.gov and not in journal publications, likely because most were secondary or exploratory outcomes. This analysis underscores the need for more comprehensive and transparent trial reporting and the role of ClinicalTrials.gov as a source of valuable patient-centered trial information.
METHODS: Drug and biologic trials for treatment or prevention of breast cancer with Study Completion Dates of 1/1/2020 to 12/31/2024 and posted results were identified on ClinicalTrials.gov. Outcome measure fields (as of 11/19/2025) were reviewed to identify PRO use and verified using a clinical outcomes assessment database, eProvide. Publications linked to ClinicalTrials.gov study records were assessed to determine whether PROs reported on ClinicalTrials.gov were also reported in corresponding publications. Both authors extracted data and resolved discrepancies through discussions.
RESULTS: Among 312 breast cancer trials reviewed, 56 (17.9%) reported PROs as trial outcomes on ClinicalTrials.gov. These trials were predominantly industry-sponsored (76.8%; 43/56) and phase 2 (42.9%; 24/56) or 3 (51.8%; 29/56). Only 7 (12.5%) used PROs as primary outcomes, and 25 (44.6%) used ≥2 PRO measures simultaneously. Across the trials, 41 unique PRO measures were reported, with EORTC QLQ-C30 most frequently used to measure global health status/quality of life. After excluding duplicates and publications without trial results, 143 linked publications were reviewed. Through publications, 32 of the 56 trials (57.1%) reported results for 20 of the 41 PRO measures.
CONCLUSIONS: Nearly half of breast cancer trials that included PROs only reported these outcomes on ClinicalTrials.gov and not in journal publications, likely because most were secondary or exploratory outcomes. This analysis underscores the need for more comprehensive and transparent trial reporting and the role of ClinicalTrials.gov as a source of valuable patient-centered trial information.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR182
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology