Pivotal Evaluation of the Accuracy of a Biomarker Used for Classification or Prediction: Standards for Study Design
By M. Pepe, Ziding Feng, H. Janes, P. Bossuyt, John D. Potter. Journal of the National Cancer Institute, 2008
688 citations recorded by the source corpus.
Research methods for biomarker evaluation lag behind those for evaluating therapeutic treatments. Although a phased approach to development of biomarkers exists and guidelines are available for reporting study results, a coherent and comprehensive set of guidelines for study design has not been delineated. We describe a nested case–control study design that involves prospective collection of specimens before outcome ascertainment from a study cohort that is relevant to the clinical application. The biomarker is assayed in a blinded fashion on specimens from randomly selected case patients and control subjects in the study cohort. We separately describe aspects of the design that relate to the clinical context, biomarker performance criteria, the biomarker test, and study size. The design can be applied to studies of biomarkers intended for use in disease diagnosis, screening, or prognosis. Common biases that pervade the biomarker research literature would be eliminated if these rigorous standards were followed.
Subfields: Molecular Biology, Radiology, Nuclear Medicine and Imaging, Statistics and Probability
View Paper: https://www.semanticscholar.org/paper/eb4062854c293d7c546ec4431f60b78ed1d6b14e
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Citations in the corpus
- Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases (2019, neutral): “(69) The NCI's Early Detection Research Network has provided a guide for the clinical development of surveillance.(70) Therefore, the prospective-specimen-collection, retrospective blind evaluation (PRoBE) design is recommended for developing new biomarkers as clinical tools, including the ones disc”
- Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases (2018, positive): “(69) The NCI's Early Detection Research Network has provided a guide for the clinical development of surveillance.(70) Therefore, the prospective-specimen-collection, retrospective blind evaluation (PRoBE) design is recommended for developing new biomarkers as clinical tools, including the ones disc”
- Diagnostic potential of saliva: current state and future applications. (2011, neutral): “現行の臨床ワーク・フロー内で、唾液診断が癌や CVD の検出が現実化する前に、バイオマーカーの 発見は不可欠で、特にどのバイオマーカー・パネルが、疾病の発症と進行に関連するかの観察、開 発さらに確認を必要とする。高い敏感度と特異度を備えたバイオマーカー・パネルを決定するため に、標的バイオマーカーの発見ならびに全プロテオームへの適用は求められている。例として、唾 液中の分子による CVD の早期発見は、早期介入に繋がり、これにより CVD の発症と死亡率が低減 するかもしれない。今後、高い敏感度と特異度を備えた個々のバイオマーカーやパネルは、唾液を 診断材料とすることを求めるようになるかもしれ”
- Gut microbiome analysis as a tool towards targeted non-invasive biomarkers for early hepatocellular carcinoma (2018, methodology): “21 It was performed in accordance with the Helsinki Declaration and Rules of Good Clinical Practice.”