Regulatory Focus™ > News Articles > IOM Releases Report on Biomarkers and Surrogate Endpoints

IOM Releases Report on Biomarkers and Surrogate Endpoints

Posted 14 February 2012 | By Alexander Gaffney, RAC 

The Institute of Medicine (IOM) released a workshop summary on 14 February that explores the evaluation process for biomarkers used to detect surrogate endpoints in chronic diseases. An initial report, Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, was requested by the US Food and Drug Administration (FDA), and released by IOM in May 2010.

Biomarkers are "indicators of normal biological processes, pathogenic processes or pharmacologic responses to an intervention," such as cholesterol, blood sugar and blood pressure levels.

The expert group assembled by IOM to discuss this report came to the non-binding conclusion that a three-part framework would be useful for developing biomarkers. This framework includes analytical validation of a biomarker, qualification of the biomarker's association with a meaningful clinical endpoint, and the ultimate utilization of the biomarker.

The panel further recommended that FDA convene expert panels to evaluate biomarkers and biomarker tests if they have any sort of regulatory impact and ensure that the "scientific rigor" used to evaluate these biomarkers is the same across all product types.

IOM also emphasized evidence-based regulation, calling for more postmarketing authority for FDA to monitor products that were approved on the basis of surrogate endpoints and authority to order studies about consumer understanding of a product approved on the basis of biomarkers.

IOM also called on the Department of Health and Human Services to "facilitate a coordinated, department-wide effort to encourage the collection and sharing of data about biomarkers for all uses, including drugs, biologics, devices and foods."

The IOM panel finally called on FDA to coordinate with other agencies to build sufficient data and vigilance systems to track the effects of biomarker utilization.

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