Considerations for using potential surrogate endpoints in cancer screening trials.
Lancet Oncol
; 25(5): e183-e192, 2024 May.
Article
in En
| MEDLINE
| ID: mdl-38697164
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.
Full text:
1
Database:
MEDLINE
Main subject:
Early Detection of Cancer
/
Neoplasms
Limits:
Humans
Language:
En
Journal:
Lancet Oncol
Journal subject:
NEOPLASIAS
Year:
2024
Type:
Article