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Journal of the National Cancer Institute Advance Access originally published online on October 8, 2009
JNCI Journal of the National Cancer Institute 2009 101(21):1446-1452; doi:10.1093/jnci/djp335
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Published by Oxford University Press 2009.

Use of Archived Specimens in Evaluation of Prognostic and Predictive Biomarkers

Richard M. Simon, Soonmyung Paik, Daniel F. Hayes

Affiliations of authors: Biometric Research Branch, National Cancer Institute, Bethesda, MD (RMS); Division of Pathology, National Surgical Adjuvant Breast and Bowel Project, University of Pittsburgh, Pittsburgh, PA (SP); Breast Oncology Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI (DFH)

Correspondence to: Richard M. Simon, DSc, Biometric Research Branch, National Cancer Institute, 9000 Rockville Pike, Bethesda, MD 20892-7434 (e-mail: rsimon{at}nih.gov).

The development of tumor biomarkers ready for clinical use is complex. We propose a refined system for biomarker study design, conduct, analysis, and evaluation that incorporates a hierarchal level of evidence scale for tumor marker studies, including those using archived specimens. Although fully prospective randomized clinical trials to evaluate the medical utility of a prognostic or predictive biomarker are the gold standard, such trials are costly, so we discuss more efficient indirect "prospective–retrospective" designs using archived specimens. In particular, we propose new guidelines that stipulate that 1) adequate amounts of archived tissue must be available from enough patients from a prospective trial (which for predictive factors should generally be a randomized design) for analyses to have adequate statistical power and for the patients included in the evaluation to be clearly representative of the patients in the trial; 2) the test should be analytically and preanalytically validated for use with archived tissue; 3) the plan for biomarker evaluation should be completely specified in writing before the performance of biomarker assays on archived tissue and should be focused on evaluation of a single completely defined classifier; and 4) the results from archived specimens should be validated using specimens from one or more similar, but separate, studies.

Manuscript received December 5, 2008; revised August 4, 2009; accepted August 27, 2009.


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J Natl Cancer Inst 2009 101: 1435. [Extract] [Full Text] [PDF]





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