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Challenges and Opportunities for Biomarker Validation

Published online by Cambridge University Press:  01 January 2021

Spencer Phillips Hey ,
Elvira D'Andrea ,
Emily H. Jung ,
Frazer Tessema ,
Jing Luo ,
Bishal Gyawali  and
Aaron S. Kesselheim
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Abstract

Biomarkers can be powerful tools to guide diagnosis, treatment, and research. However, prudent use of biomarkers requires formal validation efforts. Although the data needed for biomarker validation has traditionally been hard to access, new research initiatives can ease this process.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 3: Biomarker Research and Validation: Current Challenges, Future Opportunities , Fall 2019 , pp. 357 - 361
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

Nissen, S. E. and Wolski, K., “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” New England Journal of Medicine 356, no. 24 (2007): 2457-2471.CrossRefGoogle Scholar
Hey, S. P., “Judging Quality and Coordination in Biomarker Diagnostic Development,” THEORIA: Revista de Teoría, Historia y Fundamentos de la Ciencia 30, no. 2 (2015): 207-227.CrossRefGoogle Scholar
FDA-NIH Biomarker Working Group, BEST (Biomarkers, EndpointS, and other Tools) Resource (Silver Spring Maryland: Food and Drug Administration (US), 2016), available at <https://www.ncbi.nlm.nih.gov/books/NBK326791/> (last visited July 1, 2019).+(last+visited+July+1,+2019).>Google Scholar
Ganann, R., Ciliska, D., and Thomas, H., “Expediting Systematic Reviews: Methods and Implications of Rapid Reviews,” Implementation Science 5, no. 1 (2010): 56.CrossRefGoogle Scholar
Hey, S. P. and Kesselheim, A. S., “Countering Imprecision in Precision Medicine,” Science 353, no 6298 (2016): 448-449.CrossRefGoogle Scholar
Hey, S. P., Franklin, J. M., Avorn, J., and Kesselheim, A. S., “Success, Failure, and Transparency in Biomarker-Based Drug Development: A Case Study of Cholesteryl Ester Transfer Protein Inhibitors,” Circulation: Cardiovascular Quality and Outcomes 10, no. 6 (2017): e003121.Google Scholar
Haslam, A., Hey, S. P., Gill, J., and Prasad, V., “A Systematic Review of Trial-Level Meta-Analyses Measuring the Strength of Association between Surrogate End-Points and Overall Survival in Oncology,” European Journal of Cancer 106 (2019): 196-211.CrossRefGoogle Scholar