Use of Archived Specimens in Evaluation of Prognostic and Predictive Biomarkers
AUTOR(ES)
Simon, Richard M.
FONTE
Oxford University Press
RESUMO
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.
ACESSO AO ARTIGO
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2782246Documentos Relacionados
- An overview of assessment of prognostic and predictive factors in breast cancer needle core biopsy specimens
- Mechanism-derived gene expression signatures and predictive biomarkers in clinical oncology
- Evaluation of Microtubule-Associated Protein-Tau Expression As a Prognostic and Predictive Marker in the NSABP-B 28 Randomized Clinical Trial
- An evaluation of tyramide signal amplification and archived fixed and frozen tissue in microarray gene expression analysis
- Prognostic factors predictive of survival for truncal and retroperitoneal soft-tissue sarcoma.