Use of EORTC Item Lists for Patient-Reported Outcome Measurement in Industry-Sponsored Research: A Three-Year Snapshot of Study Characteristics
Author(s)
Claire Piccinin, MSc1, Christopher Bedding, PhD2, Dagmara Kulis, MA1, Bonnie Pacheco, MA1, Rosemary Peacock, PhD2, Alexandra Gilbert, PhD, FRCR2.
1Quality of Life Department, EORTC Headquarters, Brussels, Belgium, 2Leeds Institute of Medical Research at St. James’s, University of Leeds, Leeds, United Kingdom.
1Quality of Life Department, EORTC Headquarters, Brussels, Belgium, 2Leeds Institute of Medical Research at St. James’s, University of Leeds, Leeds, United Kingdom.
OBJECTIVES: The European Organisation for Research and Treatment of Cancer (EORTC) Item Library supports the flexible assessment of patient-reported outcomes (PROs) by facilitating the creation of customised item lists through the pool of available items derived from EORTC questionnaires. These item lists complement standard static measures to capture, e.g., missing symptoms and adverse events as treatment paradigms and study designs evolve. This work aimed to evaluate the use of EORTC item lists in industry-sponsored studies over a 3-year period, highlighting study attributes and trends.
METHODS: A database was created to descriptively summarise key characteristics per study related to design, population, experimental treatment, and PRO measurement strategy. Anonymous information was extracted from EORTC licensing documents executed from January 2022 through December 2024, and online clinical trials registries were consulted to verify study details.
RESULTS: Overall, 105/848 (12%) commercial licenses for studies included at least one item list, increasing from 8% of licenses in 2022 to 17% in 2024. Almost all studies were clinical trials (95%) with 52% phase III trials. Most studies involved patients with lung cancer (28%), mixed disease types (14%), and breast cancer (13%), and 57% of studies involved patients with advanced/metastatic disease. The most common experimental treatment type was targeted therapy (29%), followed by immunotherapy (16%), and combination targeted/immunotherapy (15%). Across all studies, 74% reported using electronic PRO assessment, 92% used the QLQ-C30 core questionnaire, and 28% used a disease-specific module. The most frequently requested item list (IL46-Q168) was used in 42% of studies to measure treatment-related side effect burden.
CONCLUSIONS: EORTC item lists provide important PRO measurement flexibility across disease types and trial phases with a focus on novel treatments, reflecting the current clinical research landscape. Item lists are most frequently administered electronically alongside a core measure, emphasising a commitment to balancing static with flexible PRO measures using digital platforms.
METHODS: A database was created to descriptively summarise key characteristics per study related to design, population, experimental treatment, and PRO measurement strategy. Anonymous information was extracted from EORTC licensing documents executed from January 2022 through December 2024, and online clinical trials registries were consulted to verify study details.
RESULTS: Overall, 105/848 (12%) commercial licenses for studies included at least one item list, increasing from 8% of licenses in 2022 to 17% in 2024. Almost all studies were clinical trials (95%) with 52% phase III trials. Most studies involved patients with lung cancer (28%), mixed disease types (14%), and breast cancer (13%), and 57% of studies involved patients with advanced/metastatic disease. The most common experimental treatment type was targeted therapy (29%), followed by immunotherapy (16%), and combination targeted/immunotherapy (15%). Across all studies, 74% reported using electronic PRO assessment, 92% used the QLQ-C30 core questionnaire, and 28% used a disease-specific module. The most frequently requested item list (IL46-Q168) was used in 42% of studies to measure treatment-related side effect burden.
CONCLUSIONS: EORTC item lists provide important PRO measurement flexibility across disease types and trial phases with a focus on novel treatments, reflecting the current clinical research landscape. Item lists are most frequently administered electronically alongside a core measure, emphasising a commitment to balancing static with flexible PRO measures using digital platforms.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR258
Topic
Methodological & Statistical Research, Patient-Centered Research, Study Approaches
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology, Personalized & Precision Medicine