• Clin. Pharmacol. Ther. · Jul 2015

    Implications of the Institute of Medicine Report: Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease.

    • J A Wagner and J R Ball.
    • Takeda Pharmaceuticals International Co, Clinical and Translational Sciences, Cambridge, Massachusetts, USA.
    • Clin. Pharmacol. Ther. 2015 Jul 1; 98 (1): 12-5.

    AbstractThe Institute of Medicine (IOM) released a groundbreaking 2010 report, Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Key recommendations included a harmonized scientific process and a general framework for biomarker evaluation with three interrelated steps: (1) Analytical validation -- is the biomarker measurement accurate? (2) Qualification -- is the biomarker associated with the clinical endpoint of concern? (3) Utilization -- what is the specific context of the proposed use?© 2015 American Society for Clinical Pharmacology and Therapeutics.

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