© 2001 by Oxford University Press
Journal of the National Cancer Institute, Vol. 93, No. 14, 1054-1061,
July 18, 2001
© 2001 Oxford University Press
COMMENTARY |
Phases of Biomarker Development for Early Detection of Cancer
Affiliations of authors: M. S. Pepe, Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle; M. L. Thompson, Department of Biostatistics, University of Washington; R. Etzioni, Z. Feng, J. D. Potter, M. Thornquist, M. Winget, Y. Yasui, Fred Hutchinson Cancer Research Center.
Correspondence to: Margaret Sullivan Pepe, Ph.D., Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195–7232 (e-mail: mspepe@u.washington.edu).
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1) INTRODUCTION |
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Recent developments in such areas of research as gene-expression microarrays, proteomics, and immunology offer new approaches to cancer screening (1). The surge in research to develop cancer-screening biomarkers prompted the establishment of the Early Detection Research Network (EDRN) by the National Cancer Institute (2). The purpose of the EDRN is to coordinate research among biomarker-development laboratories, biomarker-validation laboratories, clinical repositories, and population-screening programs. By coordination of research efforts, the hope is to facilitate collaboration and to promote efficiency and rigor in research.
With the goals of the EDRN in mind, the purpose of this commentary is to define a formal structure to guide the process of biomarker development. We categorize the development into five phases that a biomarker needs to pass through to produce a useful population-screening tool. The phases of research are generally ordered according to the strength of evidence that each provides in favor
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2) OBJECTIVES OF POPULATION SCREENING |
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3) FIVE PHASES OF SCREENING BIOMARKER DEVELOPMENT |
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3.1) Phase 1—Preclinical Exploratory Studies
Primary Aims Specimen Selection Primary Outcome Measures Evaluation of Study Results Sample Sizes 3.2) Phase 2—Clinical Assay Development for Clinical Disease
Primary Aim Secondary Aims Specimen Selection Primary Outcome Measure Evaluation of Study Results Sample Sizes 3.3) Phase 3—Retrospective Longitudinal Repository Studies
Primary Aims Secondary Aims Specimen Selection Primary Outcome Measure Evaluation of Study Results: an Example Sample Sizes 3.4) Phase 4—Prospective Screening Studies
Primary Aim Secondary Aims Subject Selection Primary Outcome Measure Evaluation of Study Results Sample Size 3.5) Phase 5—Cancer Control Studies
Primary Aim Secondary Aims Subject Selection Primary Outcome Measure Evaluation of Study Results Sample Size
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4) DISCUSSION |
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NOTES |
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