US FDA and NIH Reveal Glossary of Clinical Definitions

US Food and Drug Administration (FDA) and  National Institutes of Health (NIH) Leadership Council has unveiled a glossary of definitions, intended to explain and illustrate some of the associations and differences among terminology applied in translational science and medical product development.1

The council’s development of the glossary is part of the initial phase of its BEST (Biomarkers, Endpoints, and other Tools) Resource and targets to capture distinctions between biomarkers and clinical assessments and to explain their roles in bio-medical research, clinical practice and product development.

The list not only explains the distinction 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 also presents examples.

“Because the glossary is designed to be broadly applicable to several communities of users and stakeholders, its descriptions address nuances of usage and interpretation for a wide range of terms presently in use,” the working group of mostly FDA authorities said.

NIH and FDA aim to use the definitions provided in this glossary, which will be regularly updated, when communicating on related topics, like as biomarkers, to make sure terms are used regularly.

The list also consists of definitions of various outcomes, such as clinician-reported, observer-reported, patient-reported and performance outcomes.

The working group states that it welcomes feedback, such as particular edits with rationale, from all stakeholders, which includes the scientific and medical communities, sufferers, providers, industry, and regulatory authorities.