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Implications of the Institute of Medicine Report: Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
- Source :
- Clinical pharmacology and therapeutics. 98(1)
- Publication Year :
- 2015
-
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?
- Subjects :
- Pharmacology
National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division
medicine.medical_specialty
Pathology
business.industry
Surrogate endpoint
Endpoint Determination
United States Food and Drug Administration
Context (language use)
Guidelines as Topic
Institute of medicine
Report evaluation
United States
Chronic disease
Government Agencies
Chronic Disease
Clinical endpoint
Medicine
Biomarker (medicine)
Humans
Pharmacology (medical)
business
Intensive care medicine
Biomarkers
Subjects
Details
- ISSN :
- 15326535
- Volume :
- 98
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Clinical pharmacology and therapeutics
- Accession number :
- edsair.doi.dedup.....771331b7da936fdcb664249d790551b8