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Pivotal Evaluation of the Accuracy of a Biomarker Used for Classification or Prediction: Standards for Study Design
Open accessAbstract
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.
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Cites
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Hastie, T., Tibshirani, R., & Friedman, J. (2009) · Springer Series in Statistics · doi:10.1007/978-0-387-84858-7 · Cited by 25,970
Phases of Biomarker Development for Early Detection of Cancer
Pepe, M. S., Etzioni, R., Feng, Z., Potter, J. D., Thompson, M. L., Thornquist, M., Winget, M., & Yasui, Y. (2001) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/93.14.1054 · Cited by 1,686
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Farrell, J. J., Zhang, L., Zhou, H., Chia, D., Elashoff, D., Akin, D., Paster, B. J., Joshipura, K., & Wong, D. T. W. (2012) · Gut · doi:10.1136/gutjnl-2011-300784 · Cited by 662
Risk factors and prevention of hepatocellular carcinoma in the era of precision medicine
Fujiwara, N., Friedman, S. L., Goossens, N., & Hoshida, Y. (2018) · Journal of Hepatology · doi:10.1016/j.jhep.2017.09.016 · Cited by 659
Trial Design and Endpoints in Hepatocellular Carcinoma: AASLD Consensus Conference
Llovet, J. M., Villanueva, A., Marrero, J. A., Schwartz, M., Meyer, T., Galle, P. R., Lencioni, R., Greten, T. F., Kudo, M., Mandrekar, S. J., et al. (2021) · Hepatology · doi:10.1002/hep.31327 · Cited by 413
Oligosaccharide Analysis by Mass Spectrometry: A Review of Recent Developments
Kailemia, M. J., Ruhaak, L. R., Lebrilla, C. B., & Amster, I. J. (2014) · Analytical Chemistry · doi:10.1021/ac403969n · Cited by 377
Detection of early pancreatic ductal adenocarcinoma with thrombospondin-2 and CA19-9 blood markers
Kim, J., Bamlet, W. R., Oberg, A. L., Chaffee, K. G., Donahue, G., Cao, X.-J., Chari, S., Garcia, B. A., Petersen, G. M., & Zaret, K. S. (2017) · Science Translational Medicine · doi:10.1126/scitranslmed.aah5583 · Cited by 269
Metadata
- Authors
- Pepe, M. S., Feng, Z., Janes, H., Bossuyt, P. M., & Potter, J. D.
- Venue
- JNCI: Journal of the National Cancer Institute
- Publisher
- Oxford University Press (OUP)
- Published
- 2008-10-15
- Volume
- 100
- Issue
- 20
- Pages
- 1432-1438
- ISSN
- 0027-8874 (ISSN-L)
- 1460-2105
- OpenAlex
- W2121032725
- Cited by
- 717
- References
- 2
- FWCI
- 37.88
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Pepe, M. S., Feng, Z., Janes, H., Bossuyt, P. M., & Potter, J. D. (2008). Pivotal Evaluation of the Accuracy of a Biomarker Used for Classification or Prediction: Standards for Study Design. JNCI: Journal of the National Cancer Institute. https://doi.org/10.1093/jnci/djn326
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