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Related Experiment Video

Updated: Jun 27, 2025

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo

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Published on: February 6, 2015

Considerations for using potential surrogate endpoints in cancer screening trials.

Alexis B Webb¹, Christine D Berg², Philip E Castle³

¹Cancer Research UK, London, UK.

The Lancet. Oncology

|May 2, 2024

Summary

Developing novel cancer screening tests is hindered by expensive, long-term trials. Surrogate endpoints offer a solution by measuring earlier outcomes than cancer mortality, but validation remains challenging.

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Area of Science:

Oncology
Clinical Trial Design
Biostatistics

Background:

Large-scale, decade-long cancer screening trials are costly and slow down innovation.
Novel screening tests face significant barriers to development, commercialization, and implementation.
Cancer mortality is the ultimate endpoint, but it occurs much later than screening interventions.

Purpose of the Study:

To review the challenges in selecting and utilizing surrogate endpoints for cancer screening trials.
To propose criteria for the appropriate use of surrogate endpoints in cancer screening.
To identify potential surrogate endpoint candidates for cancer screening.

Main Methods:

Literature review of current landscape and challenges in surrogate endpoint use.
Analysis of lessons learned and shortcomings from therapeutic trial settings.
Discussion of candidate surrogate endpoints against defined research and regulatory criteria.

Main Results:

Significant challenges exist in validating surrogate endpoints, even with robust study designs.
The current landscape of surrogate endpoint use in cancer screening is complex.
Lessons from therapeutic trials highlight both potential and pitfalls of surrogate endpoints.

Conclusions:

Surrogate endpoints are a potential strategy to accelerate cancer screening test development.
Rigorous validation is crucial but difficult for surrogate endpoints in cancer screening.
Further research is needed to identify and validate suitable surrogate endpoints for regulatory acceptance.