Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease

Type: Consensus Study
Topics: Biomedical and Health Research, Diseases, Quality and Patient Safety
Boards: Food and Nutrition Board, Board on Health Care Services, Board on Health Sciences Policy

Activity Description

An IOM committee will be convened to generate recommendations on the qualification process for biomarkers, with focus on risk biomarkers and surrogate endpoints in chronic disease. These recommendations will consider existing prototypes for qualification of biomarkers used in drug development. The committee will recommend a framework for qualification and test it using case studies of risk biomarkers and surrogate endpoints for coronary heart disease such as low-density and high-density lipoprotein cholesterol levels. In particular, the committee will:

1. Conduct a review of current approaches to qualifying biomarkers.

2. Recommend a framework that can be used to rank biomarkers according to the types and quality of evidence, considering context of use for a range of product types.

3. Demonstrate applications through case studies.

4. Make ancillary recommendations for the application, enhanced development, and use of risk biomarkers and surrogate endpoints in chronic disease.

This project is sponsored by the Food and Drug Administration. The approximate start date of this project is 12/15/2008. The final report will be issued on or before May 18, 2010

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