title: Implications of the Institute of Medicine Report: Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease.
abstract: The 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?
authors.affiliation: Takeda Pharmaceuticals International Co, Clinical and Translational Sciences, Cambridge, Massachusetts, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Wagner
authors.affiliation: American College of Physicians, Philadelphia, Pennsylvania, USA.
authors.forename: J R
authors.initials: JR
authors.lastname: Ball
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D002908:Chronic Disease; D023381:Endpoint Determination / Q000379:methods; D006077:Government Agencies; D017408:Guidelines as Topic; D006801:Humans; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers