December 7, 2017 — Science Translational Medicine has published an article by experts from the Foundation for the National Institutes of Health, the National Institutes of Health, the U.S. Food and Drug Administration (FDA), industry, academia and not-for-profit organizations that outlines a framework for the level of evidence needed to support qualification of biological markers (biomarkers) for use in drug development decision making. While biomarkers can facilitate all aspects of drug development, their use has been hampered by lack of a clear and predictable process to qualify new markers with the FDA.

The “Framework for Defining Evidentiary Criteria for Biomarker Qualification” outlined in the paper was developed through a coordinated effort in 2016 by more than 200 government and industry stakeholders. Their intent was to improve the quality of biomarker submissions to the FDA, enhance the predictability of the qualification process and clarify the type and extent of evidence needed to support the biomarker’s context of use.

This article outlines the framework’s key features, the methodologies and assumptions used to create it as well as provides a history of the milestones in biomarker qualification guidelines. For more information and to read the full framework, click here.