FDA, NIH Unveil Glossary of Clinical Definitions
A joint US Food and Drug Administration (FDA), National Institutes of Health (NIH) Leadership Council has released a glossary of definitions, meant to clarify and describe some of the relationships, connections and distinctions among terms used in translational science and medical product development.
The council’s development of the glossary is part of the first phase of its BEST (Biomarkers, Endpoints, and other Tools) Resource and aims to capture differences between biomarkers and clinical assessments and to describe their roles in biomedical research, clinical practice and product development.
The list not only clarifies the difference between a “pharmacodynamic/response biomarker,” a “susceptibility/risk biomarker,” a “predictive biomarker,” a “monitoring biomarker,” a “diagnostic biomarker,” a “safety biomarker” and a “prognostic biomarker,” but provides examples, as well.
“Because the glossary is intended to be broadly applicable to multiple communities of users and stakeholders, its definitions address nuances of usage and interpretation for a wide variety of terms currently in use,” the working group of mostly FDA officials said.
NIH and FDA intend to use the definitions included in this glossary, which will be periodically updated, when communicating on related topics, such as biomarkers, to ensure terms are used consistently.
The list also includes definitions of different outcomes, including clinician-reported, observer-reported, patient-reported and performance outcomes.
The working group says it welcomes feedback, including specific edits with rationale, from all stakeholders, including the scientific and medical communities, patients, providers, industry, and regulators.