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 |
| Open access status: | An open access version is available from UCL Discovery |
| 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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