This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Maruvada, P. Articles by Srivastava, S. Search for Related Content PubMed PubMed Citation Articles by Maruvada, P. Articles by Srivastava, S. Related Collections Epidemiology and Prevention Epidemiology and Prevention: Genetics and Biomarkers

Joint National Cancer Institute-Food and Drug Administration Workshop on Research Strategies, Study Designs, and Statistical Approaches to Biomarker Validation for Cancer Diagnosis and Detection

Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, NIH, Bethesda, Maryland

Requests for reprints: Sudhir Srivastava, Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, NIH, Executive Plaza North, Room 3142, 6130 Executive Boulevard, MSC 7346, Bethesda, MD 20892-7346. Phone: 301-496-3983; Fax: 301-402-8990. E-mail: ss1a{at}nih.gov

Cancer remains the second leading cause of death in the United States, in spite of tremendous advances made in therapeutic and diagnostic strategies. Successful cancer treatment depends on improved methods to detect cancers at early stages when they can be treated more effectively. Biomarkers for early detection of cancer enable screening of asymptomatic populations and thus play a critical role in cancer diagnosis. However, the approaches for validating biomarkers have yet to be addressed clearly. In an effort to delineate the ambiguities related to biomarker validation and related statistical considerations, the National Cancer Institute, in collaboration with the Food and Drug Administration, conducted a workshop in July 2004 entitled "Research Strategies, Study Designs, and Statistical Approaches to Biomarker Validation for Cancer Diagnosis and Detection." The main objective of this workshop was to review basic considerations underpinning the study designs, statistical methodologies, and novel approaches necessary to rapidly advance the clinical application of cancer biomarkers. The current commentary describes various aspects of statistical considerations and study designs for cancer biomarker validation discussed in this workshop. (Cancer Epidemiol Biomarkers Prev 2006;15(6):1078–82)

This article has been cited by other articles:

				J. Cummings, C. Hodgkinson, R. Odedra, P. Sini, S. P. Heaton, K. E. Mundt, T. H. Ward, R. W. Wilkinson, J. Growcott, A. Hughes, et al. Preclinical evaluation of M30 and M65 ELISAs as biomarkers of drug induced tumor cell death and antitumor activity Mol. Cancer Ther., March 1, 2008; 7(3): 455 - 463. [Abstract] [Full Text] [PDF]

				L. Kuller Is Phenomenology the Best Approach to Health Research? Am. J. Epidemiol., November 15, 2007; 166(10): 1109 - 1115. [Abstract] [Full Text] [PDF]

				D. B. Seligson, F. Hongo, S. Huerta-Yepez, Y. Mizutani, T. Miki, H. Yu, S. Horvath, D. Chia, L. Goodglick, and B. Bonavida Expression of X-Linked Inhibitor of Apoptosis Protein Is a Strong Predictor of Human Prostate Cancer Recurrence Clin. Cancer Res., October 15, 2007; 13(20): 6056 - 6063. [Abstract] [Full Text] [PDF]

				H. K. Roy and J. D. Khandekar Biomarkers for the Early Detection of Cancer: An Inflammatory Concept Arch Intern Med, September 24, 2007; 167(17): 1822 - 1824. [Full Text] [PDF]