Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification—the use of a biomarker that is accepted by the US Food and Drug Administration—needs a clear, predictable process. We describe a multi-stakeholder effort including government, industry, and academia that proposes a framework for defining the amount of evidence needed for biomarker qualification. This framework is intended for broad applications across multiple biomarker categories and uses.
Figure 1: Proposed evidentiary criteria framework. An illustration of the steps in the process for defining the appropriate amount of evidence needed to use a biomarker from the point of view of regulatory decision-making. The process requires defining the detailed limits of the decision and collecting the appropriate data based on how the decision will affect patients. Given the complexity of data collection, the process involves multiple conversations with the regulatory agency and can circle back if the decision or COU needs to be changed during the process
