Encyclopedia of Cancer

2011 Edition
| Editors: Manfred Schwab

Surrogate Endpoint

Reference work entry
DOI: https://doi.org/10.1007/978-3-642-16483-5_5602



A surrogate endpoint is an outcome observed prior to a health outcome of interest (called the true endpoint) that is used to make conclusions about the effect of intervention on the true endpoint.


Role of Surrogate Endpoints in Cancer Research

The role of surrogate endpoints in cancer research depends on the purposes of the analysis. The main roles are to
  • Shorten the length of time needed to evaluate a new treatment for clinical use.

  • Quickly and cheaply evaluate interventions at an early phase of development as a prelude to more rigorous evaluation.

Ideally, these roles require the surrogate endpoint to be validated. As with so many terms used in the medical literature, the meaning of the term “validation” can vary among medical scientists. We define validation of a surrogate endpoint as a formal process of data analysis for determining how well the surrogate endpoint can be used...

This is a preview of subscription content, log in to check access.


  1. 1.
    Baker SG (2006) Surrogate endpoints: wishful thinking or reality. J Natl Cancer Inst 98:502–503PubMedCrossRefGoogle Scholar
  2. 2.
    Johnson KR, Ringlard C, Stokes BJ et al (2006) Response rate or time to progression as predictors of survival in trials of metastatic colorectal cancer or non-small-cell lung cancer: a meta-analysis. Lancet Oncol 7:741–746PubMedCrossRefGoogle Scholar
  3. 3.
    Lassere MN, Johnson KR, Boers M et al (2007) Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema. J Rheumatol Journal of pheumatology 34(3):607–615Google Scholar
  4. 4.
    Sargent DJ, Wieand HJ, Haller DG et al (2005) Disease-free survival versus overall survival as a primary endpoint for adjuvant colon cancer studies: individual patient data form 20,898 patients on 18 randomized trials. J Clin Oncol 23:8664–8670PubMedCrossRefGoogle Scholar
  5. 5.
    Weir CJ, Walley RJ (2006) Statistical evaluation of biomarkers as surrogate endpoints: a literature review. Stat Med 25:83–203CrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2011

Authors and Affiliations

  1. 1.Biometry Research GroupNational Cancer InstituteBethesdaUSA
  2. 2.Office of Disease PreventionNational Institutes of HealthBethesdaUSA