Phases of biomarker development for early detection of cancer.

By M. Pepe, Ruth Etzioni, Z. Feng, John D. Potter, M. Thompson, M. Thornquist, M. Winget, Y. Yasui. Journal of the National Cancer Institute, 2001

1,655 citations recorded by the source corpus.

Subfields: Cancer Research, Molecular Biology, Statistics and Probability

View Paper: https://www.semanticscholar.org/paper/0db60edfc3e7fa608ca8583aa4c9e7b2ce1c4419

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Citations in the corpus

Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives (2010, neutral): “The most valuable role for biomarkers has been identified by the US Food and Drug Administration (FDA), and the National Cancer Institut”
Methods of in vitro toxicology. (2002, background): “Thus, the biomarkers discussed here are mainly related to the impact of exogenous factors for cancer risks and are not identical to those dealing with the early detection of the cancer disease (Pepe et al., 2001).”
Early detection: The case for early detection (2003, neutral): “have organized the types of studies that are required into five phases, which we now describ”
Early detection: The power and the promise of DNA methylation markers (2003, neutral): “Here, the clinical sensitivity of a biomarker refers to the proportion of case subjects (individuals with confirmed disease) who test positive for the biomarker assay, whereas the specificity refers to the proportion of control subjects (individuals without the disease) who test negative for the bio”
Strategies for discovering novel cancer biomarkers through utilization of emerging technologies (2008, background): “Conclusions Biomarker development falls into five conceptual phases: preclinical exploratory studies; clinical assay and validation; retrospective longitudinal studies; prospective screening; and randomized control trials ( Box 4 )”
Alpha-fetoprotein, Des-gamma Carboxyprothrombin, and Lectin-Bound Alpha-fetoprotein in Early Hepatocellular Carcinoma (2009, background): “The National Cancer Institute’s Early Detection Research Network (EDRN) has developed guidelines on phases of evaluating an early detection biomarker for cancer, analogous to the degrees of evidence seen in the various phases of drug discovery (9).”
Recurrence of endometriosis and its control. (2009, background): “, 1979) and the development of biomarkers for the early detection of cancer (Pepe et al., 2001; Feng et al., 2004).”
Partially Supervised Learning Using an EM‐Boosting Algorithm (2004, background): “See Pepe et al. (2001) for a wide range of other issues relevant to biomarker developments from case–controls studies to prospective population-based evaluations.”
Operating characteristics of prostate-specific antigen in men with an initial PSA level of 3.0 ng/ml or lower. (2005, methodology): “Funding/Support: This study was supported in part by Public Health Service grants CA 37429, CA 35178, CA 45808, and CA 86402 from the National Cancer Institute.”
Salivary Transcriptome Diagnostics for Oral Cancer Detection (2004, result): “Because of these concerns and the recommendations of the Early Detection Research Network (EDRN) of the National Cancer Institute (31), the next step will be to validate our results in an independent cohort with a larger sample size.”
Biomarkers in Cancer Staging, Prognosis and Treatment Selection (2005, background): “Five conceptual phases of biomarker development have been proposed: preclinical exploratory (I), clinical assay and validation (II), retrospective longitudinal (III), prospective screening (IV) and cancer control (V”
Decision Curve Analysis: A Novel Method for Evaluating Prediction Models (2006, background): “First, such measures are vital in the early stages of developing diagnostic and prognostic strategies—for example, when determining whether a biomarker shows any evidence of value on a convenience sample or when calibrating instruments or techniques.(17) Second, although it is possible for a model t”
Estimation and Comparison of Receiver Operating Characteristic Curves (2009, positive): “If selection to the study was outcome dependent (that is, if a case–control design was used, as is common in early phase studies [Pepe et al. 2001]), then resampling is done separately within case and control strata.”