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Considerations for using potential surrogate endpoints in cancer screening trials

Webb, AB; Berg, CD; Castle, PE; Crosby, D; Etzioni, R; Kessler, LG; Menon, U; ... Sasieni, PD; + view all (2024) Considerations for using potential surrogate endpoints in cancer screening trials. The Lancet Oncology , 25 (5) e183-e192. 10.1016/S1470-2045(24)00015-9.

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Abstract

The requirement of large-scale expensive cancer screening trials spanning decades creates considerable barriers to the development, commercialisation, and implementation of novel screening tests. One way to address these problems is to use surrogate endpoints for the ultimate endpoint of interest, cancer mortality, at an earlier timepoint. This Review aims to highlight the issues underlying the choice and use of surrogate endpoints for cancer screening trials, to propose criteria for when and how we might use such endpoints, and to suggest possible candidates. We present the current landscape and challenges, and discuss lessons and shortcomings from the therapeutic trial setting. It is hugely challenging to validate a surrogate endpoint, even with carefully designed clinical studies. Nevertheless, we consider whether there are candidates that might satisfy the requirements defined by research and regulatory bodies.

Type: Article
Title: Considerations for using potential surrogate endpoints in cancer screening trials
Location: England
DOI: 10.1016/S1470-2045(24)00015-9
Publisher version: https://doi.org/10.1016/S1470-2045(24)00015-9
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Humans, Early Detection of Cancer, Neoplasms, Biomarkers, Tumor, Clinical Trials as Topic, Research Design, Biomarkers, Endpoint Determination
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10192764
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