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Surrogate Endpoints in Cancer Clinical Trials

  • Stephen L. George
Part of the The IMA Volumes in Mathematics and its Applications book series (IMA, volume 116)

Abstract

Cancer is a major public health problem in the United States and worldwide. In the U.S. in 1996, an estimated 1,360,000 new cases of cancer were diagnosed, and an estimated 555,000 cancer patients died of their disease [1]. The current estimated lifetime risk of developing an invasive cancer is one in three for woman and an amazing one in two for men. The disease “cancer” is a diverse set of diseases, with the common characteristics of invasion of normal tissues by cancer cells and the propensity of these cells to spread, or metastasize, beyond the site of origin. All cancers also share the potential to cause significant morbidity and death. However, the natural history, epidemiology, biology, prevention, detection, and treatment of cancer varies widely by the specific type of cancer. Among other things, these differences necessitate different approaches for each type of cancer in the design and analysis of cancer clinical trials.

Although the field with the largest literature and interest in surrogate endpoints is perhaps AIDS research [2–6], this topic has received increasing attention in recent years in cancer research as well [7–9]. The purpose of this paper is to discuss the role of surrogate endpoints in cancer clinical trials, including prevention, screening, and therapeutic trials. Examples of trials in prostate cancer, breast cancer, and lung cancer will be used to illustrate the key points.

Keywords

Prostate Cancer Beta Carotene Surrogate Endpoint Cancer Clinical Trial Chemoprevention Trial 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media New York 2000

Authors and Affiliations

  • Stephen L. George
    • 1
  1. 1.Division of BiometryDuke University Medical CenterDurhamUSA

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