Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease – Institute of Medicine – 12 May 2010

Posted on May 13, 2010. Filed under: Chronic Disease Mgmt | Tags: , |

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease – Institute of Medicine – 12 May 2010
Type: Consensus Report
Full text

“Doctors, scientists, and other health professionals use biomarkers as tools to obtain information about a person’s health status or response to interventions. Biomarkers, defined as characteristics that indicate biological processes, are essential for monitoring the health of both individuals and communities. Some biomarkers, called surrogate endpoints, are used as sub­stitutes for actual clinical endpoints such as incidence of disease or death. Surrogate endpoints are intended to predict benefit or harm based on scien­tific evidence, and they are used in practice when it is difficult to collect data based on clinical endpoints.

In 2008, the Food and Drug Administration (FDA) asked the IOM to conduct a study on the evaluation process for biomark­ers, focusing on biomarkers and surrogate endpoints in chronic disease. The FDA’s Center for Food Safety and Applied Nutrition initiated this study at a time when it was faced with hundreds of applications for review of food health claims based on stated effects on biomarkers.

In this report, the IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.”  … continues

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