Sardana, G., B. Dowell, and E.P. Diamandis. 2008. Emerging biomarkers for the diagnosis and prognosis of prostate cancer. Clinical Chemistry 54(12):1951–1960.

Shi, Q., and D. J. Sargent. 2009. Meta-analysis for the evaluation of surrogate endpoints in cancer clinical trials. International Journal of Clinical Oncology 14(2):102–111.

Spilker, B. 1991. Surrogate endpoints. In Guide to clinical trials. New York: Raven Press. Pp. 608–609.

Spilker, B. 2009. Surrogate endpoints and biomarkers. In Guide to drug development: A comprehensive review and assessment. Philadelphia, PA: Lippincott Williams and Wilkins.

Temple, R. J. 1995. A regulatory authority’s opinion about surrogate endpoints. In Clinical measurement in drug evaluation, edited by W. S. Nimmo and G. T. Tucker. New York: John Wiley and Sons. Pp. 3–22.

Trumbo, P., and K. Ellwood. 2009. Developing a framework for biomarker qualification for chronic disease. Paper presented at Institute of Medicine Committee on Qualification of Biomarkers as Surrogate Endpoints for Chronic Disease Risk, Washington, DC, January 12.

Wagner, J. A. 2002. Overview of biomarkers and surrogate endpoints in drug development. Disease Markers 18(2):41–46.

Wagner, J. A. 2008. Strategic approach to fit-for-purpose biomarkers in drug development. Annual Review of Pharmacology and Toxicology 48:631–651.

WHO (World Health Organization). 2001. Biomarkers in risk assessment: Validity and validation. Environmental health criteria 222. http://www.inchem.org/documents/ehc/ehc/ech222.htm (accessed March 16, 2010).



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