Core Outcome Sets in Cancer Clinical Trials: Current Status and Future Opportunities – An EORTC Perspective

Ailbhe Lawlor; Steven MacLennan; Jan  Bogaerts; Saskia Litiere; Vassilis  Golfinopoulos; Jens Lehmann; Petr   Szturz; Paula R. Williamson; Mieke Van Hemelrijck

doi:10.1186/s13063-025-08812-y

Core Outcome Sets in Cancer Clinical Trials: Current Status and Future Opportunities – An EORTC Perspective

Ailbhe Lawlor^* (Corresponding Author)
, Steven MacLennan
, Jan Bogaerts
, Saskia Litiere
, Vassilis Golfinopoulos
, Jens Lehmann
, Petr Szturz
, Paula R. Williamson
, Mieke Van Hemelrijck

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

Abstract

Background
Inconsistent, varied, and selective outcome reporting is problematic in clinical trials. Core outcome sets (COS) standardise the outcomes that should be measured and reported in all trials in a specific area of health or health care. We reviewed available cancer COS and assessed their uptake in cancer clinical trials through surveying members of the European Organisation for Research and Treatment of Cancer (EORTC).
Methods
This study employs an exploratory cross-sectional design across two phases. The Core Outcome Measures in Effectiveness Trials (COMET) Initiative database was searched for cancer-specific COS on June 1st, 2023. Awareness and use of COS amongst EORTC trialists was assessed in November 2023 via an online survey.
Results
We identified a total of 85 cancer-related COS on the COMET database. Of these, 69 related to the tumour types as categorised by the EORTC and their disease orientated groups. A total of 710 EORTC members responded of whom half (50%) stated they were unfamiliar with COS. Relevant COS were available to over a quarter of respondents, with a tenth utilising available COS. Those who chose not to use an available COS, cited volume of outcomes, lack of time and infrastructure for implementation as key barriers.
Conclusions
Whilst COS are becoming increasingly available to, and acknowledged by, cancer clinical trialists, their implementation is currently still limited. Our findings indicate that further development of COS to fill gaps for missing tumour types, greater involvement of trialists in the COS development process, and increased awareness and understanding of COS amongst trialists are all required to ensure widespread implementation of COS in cancer clinical trials.

Original language	English
Article number	129
Number of pages	9
Journal	Trials
Volume	26
Issue number	1
Early online date	9 Apr 2025
DOIs	https://doi.org/10.1186/s13063-025-08812-y
Publication status	Published - Dec 2025

Bibliographical note

No funding has been received for this project.

Data Availability Statement

Data availability: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s13063-025-08812-y.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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Cite this

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title = "Core Outcome Sets in Cancer Clinical Trials: Current Status and Future Opportunities – An EORTC Perspective",

abstract = "Background Inconsistent, varied, and selective outcome reporting is problematic in clinical trials. Core outcome sets (COS) standardise the outcomes that should be measured and reported in all trials in a specific area of health or health care. We reviewed available cancer COS and assessed their uptake in cancer clinical trials through surveying members of the European Organisation for Research and Treatment of Cancer (EORTC). Methods This study employs an exploratory cross-sectional design across two phases. The Core Outcome Measures in Effectiveness Trials (COMET) Initiative database was searched for cancer-specific COS on June 1st, 2023. Awareness and use of COS amongst EORTC trialists was assessed in November 2023 via an online survey. Results We identified a total of 85 cancer-related COS on the COMET database. Of these, 69 related to the tumour types as categorised by the EORTC and their disease orientated groups. A total of 710 EORTC members responded of whom half (50\%) stated they were unfamiliar with COS. Relevant COS were available to over a quarter of respondents, with a tenth utilising available COS. Those who chose not to use an available COS, cited volume of outcomes, lack of time and infrastructure for implementation as key barriers. Conclusions Whilst COS are becoming increasingly available to, and acknowledged by, cancer clinical trialists, their implementation is currently still limited. Our findings indicate that further development of COS to fill gaps for missing tumour types, greater involvement of trialists in the COS development process, and increased awareness and understanding of COS amongst trialists are all required to ensure widespread implementation of COS in cancer clinical trials. ",

author = "Ailbhe Lawlor and Steven MacLennan and Jan Bogaerts and Saskia Litiere and Vassilis Golfinopoulos and Jens Lehmann and Petr Szturz and Williamson, \{Paula R.\} and \{Van Hemelrijck\}, Mieke",

note = "No funding has been received for this project.",

year = "2025",

month = dec,

doi = "10.1186/s13063-025-08812-y",

language = "English",

volume = "26",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

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TY - JOUR

T1 - Core Outcome Sets in Cancer Clinical Trials

T2 - Current Status and Future Opportunities – An EORTC Perspective

AU - Lawlor, Ailbhe

AU - MacLennan, Steven

AU - Bogaerts , Jan

AU - Litiere, Saskia

AU - Golfinopoulos , Vassilis

AU - Lehmann, Jens

AU - Szturz, Petr

AU - Williamson, Paula R.

AU - Van Hemelrijck, Mieke

N1 - No funding has been received for this project.

PY - 2025/12

Y1 - 2025/12

N2 - Background Inconsistent, varied, and selective outcome reporting is problematic in clinical trials. Core outcome sets (COS) standardise the outcomes that should be measured and reported in all trials in a specific area of health or health care. We reviewed available cancer COS and assessed their uptake in cancer clinical trials through surveying members of the European Organisation for Research and Treatment of Cancer (EORTC). Methods This study employs an exploratory cross-sectional design across two phases. The Core Outcome Measures in Effectiveness Trials (COMET) Initiative database was searched for cancer-specific COS on June 1st, 2023. Awareness and use of COS amongst EORTC trialists was assessed in November 2023 via an online survey. Results We identified a total of 85 cancer-related COS on the COMET database. Of these, 69 related to the tumour types as categorised by the EORTC and their disease orientated groups. A total of 710 EORTC members responded of whom half (50%) stated they were unfamiliar with COS. Relevant COS were available to over a quarter of respondents, with a tenth utilising available COS. Those who chose not to use an available COS, cited volume of outcomes, lack of time and infrastructure for implementation as key barriers. Conclusions Whilst COS are becoming increasingly available to, and acknowledged by, cancer clinical trialists, their implementation is currently still limited. Our findings indicate that further development of COS to fill gaps for missing tumour types, greater involvement of trialists in the COS development process, and increased awareness and understanding of COS amongst trialists are all required to ensure widespread implementation of COS in cancer clinical trials.

AB - Background Inconsistent, varied, and selective outcome reporting is problematic in clinical trials. Core outcome sets (COS) standardise the outcomes that should be measured and reported in all trials in a specific area of health or health care. We reviewed available cancer COS and assessed their uptake in cancer clinical trials through surveying members of the European Organisation for Research and Treatment of Cancer (EORTC). Methods This study employs an exploratory cross-sectional design across two phases. The Core Outcome Measures in Effectiveness Trials (COMET) Initiative database was searched for cancer-specific COS on June 1st, 2023. Awareness and use of COS amongst EORTC trialists was assessed in November 2023 via an online survey. Results We identified a total of 85 cancer-related COS on the COMET database. Of these, 69 related to the tumour types as categorised by the EORTC and their disease orientated groups. A total of 710 EORTC members responded of whom half (50%) stated they were unfamiliar with COS. Relevant COS were available to over a quarter of respondents, with a tenth utilising available COS. Those who chose not to use an available COS, cited volume of outcomes, lack of time and infrastructure for implementation as key barriers. Conclusions Whilst COS are becoming increasingly available to, and acknowledged by, cancer clinical trialists, their implementation is currently still limited. Our findings indicate that further development of COS to fill gaps for missing tumour types, greater involvement of trialists in the COS development process, and increased awareness and understanding of COS amongst trialists are all required to ensure widespread implementation of COS in cancer clinical trials.

U2 - 10.1186/s13063-025-08812-y

DO - 10.1186/s13063-025-08812-y

M3 - Article

C2 - 40205620

SN - 1745-6215

VL - 26

JO - Trials

JF - Trials

IS - 1

M1 - 129

ER -

Core Outcome Sets in Cancer Clinical Trials: Current Status and Future Opportunities – An EORTC Perspective

Abstract

Bibliographical note

Data Availability Statement

UN SDGs

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