Amdal, C. D., Falk, R. S., Alanya, A. et al. (57 more authors) (2025) SISAQOL-IMI consensus-based guidelines to design, analyse, interpret and present patient-reported outcomes in cancer clinical trials. The Lancet Oncology, 26 (12). e683-e693. ISSN: 1470-2045
Abstract
Standardising the implementation of patient-reported outcomes (PROs) in clinical trials is crucial for evaluating the benefits and risks of cancer treatments. The Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) has developed 146 consensus-based recommendations for designing, analysing, interpreting, and presenting PROs in cancer clinical trials. This initiative, undertaken from 2021 to 2025, involved experts, including statisticians, PRO measurement experts, clinicians, and patient representatives from 41 organisations representing regulatory agencies, academia, the pharmaceutical industry, health–technology assessment bodies, and patient advocates. SISAQOL-IMI provides guidance on the implementation of PROs in randomised controlled trials and single-arm trials, terminology, definitions and the selection of PRO score interpretation thresholds, and for visualising PRO results for different audiences. To facilitate the implementation of these standards, in addition to this Policy Review, four key outputs are available: an interactive table, a guidebook, plain language materials, and a glossary.
Metadata
| Item Type: | Article |
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| Authors/Creators: |
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| Copyright, Publisher and Additional Information: | This is an author produced version of an article published in The Lancet Oncology, made available under the terms of the Creative Commons Attribution License (CC-BY), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited. |
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| Institution: | The University of Leeds |
| Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) |
| Date Deposited: | 22 Oct 2025 08:42 |
| Last Modified: | 02 Dec 2025 15:03 |
| Published Version: | https://www.sciencedirect.com/science/article/pii/... |
| Status: | Published |
| Publisher: | Elsevier |
| Identification Number: | 10.1016/S1470-2045(25)00520-0 |
| Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:233264 |
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Filename: SISAQOL-IMI Final Publication_PrePrint.pdf
Licence: CC-BY 4.0
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