Biomarkers can be powerful tools to guide diagnosis, treatment, and research. However, prudent use of bio-markers requires formal validation efforts. Although the data needed for biomarker validation has traditionally been hard to access, new research initiatives can ease this process.
Get full access to this article
View all access options for this article.
References
1.
S. E.Nissen and K.Wolski, “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,”New England Journal of Medicine356, no. 24 (2007): 2457-2471.
2.
S. P.Hey, “Judging Quality and Coordination in Biomarker Diagnostic Development,”THEORIA: Revista de Teoría, Historia y Fundamentos de la Ciencia30, no. 2 (2015): 207-227.
3.
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).
4.
R.Ganann, D.Ciliska, and H.Thomas, “Expediting Systematic Reviews: Methods and Implications of Rapid Reviews,”Implementation Science5, no. 1 (2010): 56.
5.
S. P.Hey and A. S.Kesselheim, “Countering Imprecision in Precision Medicine,”Science353, no 6298 (2016): 448-449.
6.
S. P.Hey, J. M.Franklin, J.Avorn, and A. S.Kesselheim, “Success, Failure, and Transparency in Biomarker-Based Drug Development: A Case Study of Cholesteryl Ester Transfer Protein Inhibitors,”Circulation: Cardiovascular Quality and Outcomes10, no. 6 (2017): e003121.
7.
A.Haslam, S. P.Hey, J.Gill, and V.Prasad, “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 Cancer106 (2019): 196-211.
