Core outcome sets in cancer clinical trials: current status and future opportunities—an EORTC perspective

被引:0
作者
Ailbhe Lawlor [1 ]
Steven MacLennan [2 ]
Jan Bogaerts [3 ]
Saskia Litiere [3 ]
Vassilis Golfinopoulos [3 ]
Jens Lehmann [4 ]
Petr Szturz [5 ]
Paula Williamson [6 ]
Mieke Van Hemelrijck [1 ]
机构
[1] Transforming Cancer Outcomes Through Research (TOUR), King’s College London, London
[2] Academic Urology Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen
[3] European Organisation for Research and Treatment of Cancer (EORTC), Brussels
[4] University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck
[5] Department of Oncology, University of Lausanne (UNIL) and Lausanne University Hospital (CHUV), Lausanne
[6] Institute of Population Health, University of Liverpool, Liverpool
关键词
D O I
10.1186/s13063-025-08812-y
中图分类号
学科分类号
摘要
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: While 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. © The Author(s) 2025.
引用
收藏
相关论文
共 34 条
  • [1] McKay P.J., Resendes S., Schemitsch E., Bhandari M., What is involved in a regulatory trial investigating a new medical device?, J Long Term Effects Med Implants, 17, 2, pp. 165-171, (2007)
  • [2] Beecher C., Galvin S., Cody A., Et al., Irish funder guidance increased searching for, and uptake of, core outcome sets, J Clin Epidemiol, 158, pp. 92-98, (2023)
  • [3] Veskimae E., Subbarayan S., Campi R., Et al., A systematic review of outcome reporting, definition and measurement heterogeneity in non-muscle invasive bladder cancer effectiveness trials of adjuvant, prophylactic treatment after transurethral resection, Bladder Cancer, 7, 2, pp. 221-241, (2021)
  • [4] Williamson P.R., Altman D.G., Bagley H., Et al., The COMET handbook: version 1.0, Trials, 18, (2017)
  • [5] Kearney A., Williamson P.R., Dodd S., A review of core outcome sets (COS) developed for different settings finds there is a subset of outcomes relevant for both research and routine care, J Clin Epidemiol, 173, (2024)
  • [6] Kirkham J.J., Davis K., Altman D.G., Et al., Core Outcome Set-STAndards for Development: the COS-STAD recommendations, PLoS Med, 14, 11, (2017)
  • [7] Saldanha I.J., Dodd S., Fish R., Et al., Comparison of published core outcome sets with outcomes recommended in regulatory guidance from the US Food and Drug Administration and European Medicines Agency: cross sectional analysis, BMJ Medicine, 1, 1, (2022)
  • [8] Passut C., Oncology trials outpacing rest of the field in complexity and duration, study shows, (2021)
  • [9] National Institute for Health and Care Excellence., (2024)
  • [10] Understanding Practice in Clinical Audit and Registries tool: UPCARE-tool, (2019)