Perspectives on Biomarker and Surrogate Endpoint Evaluation – Workshop Summary from the Institute of Medicine

Posted on January 19, 2011. Filed under: Chronic Disease Mgmt, Pathology | Tags: , , |

Perspectives on Biomarker and Surrogate Endpoint Evaluation – Workshop Summary from the Institute of Medicine
18 January 2011

“Doctors, scientists, and other health professionals use biomarkers as tools to obtain information about a person’s health status or response to interventions. Defined as characteristics that indicate biological processes, biomarkers are essential for monitoring the health of both individuals and communities. In 2008, the Food and Drug Administration (FDA) asked the IOM to conduct a study on the evaluation process for biomark¬ers, focusing on biomarkers and surrogate endpoints in chronic disease. In its report Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the IOM recommends that the FDA adopt a consistent scientific framework to evaluate biomarkers, consisting of three steps: analytical validation, evidentiary qualification, and utilization analysis.

The IOM held a workshop June 21-22, 2010, to provide stakeholders with an opportunity to learn about, react to, and discuss the report. Presenters provided perspectives on the report from the point of view of participants from the FDA, the National Institutes of Health, and from a diverse group of industry stakeholders. This document summarizes the workshop.”

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