Considerations for using potential surrogate endpoints in cancer screening trials - 30/04/24
Doi : 10.1016/S1470-2045(24)00015-9
Alexis B Webb, PhD a, Christine D Berg, MD b, Philip E Castle, PhD c, David Crosby, PhD a, Ruth Etzioni, ProfPhD d, Larry G Kessler, ProfScD e, Usha Menon, ProfFRCOG f, Mahesh Parmar, ProfPhD f, Robert J C Steele, ProfPhD g, Peter D Sasieni, ProfPhD h, i, ⁎ 
a Cancer Research UK, London, UK
b Early Cancer Detection Consultant, Bethesda, MD, USA
c Division of Cancer Prevention and Division of Cancer Epidemiology and Genetics, US National Cancer Institute, Rockville, MD, USA
d Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
e Department of Health Systems and Population Health (HSPOP), School of Public Health, University of Washington, Seattle, WA, USA
f Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK
g University of Dundee, Department of Surgery, Ninewells Hospital, Dundee, UK
h The Cancer Research UK and King’s College London Cancer Prevention Trials Unit, King’s College London, London, UK
i Wolfson Institute of Population Health, Queen Mary University of London, London, UK
*Correspondence to: Prof Peter D Sasieni, Wolfson Institute of Population Health, Queen Mary University of London, London EC1M 6BQ, UKWolfson Institute of Population HealthQueen Mary University of LondonLondonEC1M 6BQUK
Summary |
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.
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© 2024
Elsevier Ltd. Tous droits réservés.
Vol 25 - N° 5
P. e183-e192 - mai 2024 Retour au numéro
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