July 24, 2019
“As part of our continued commitment to improving health outcomes, today we are asking for public comment regarding terms in the BEST (Biomarkers, Endpoints and other Tools) glossary, a resource that discusses scientific terms and concepts regarding study endpoints and biomarkers. Developed in partnership with the National Institutes of Health, the goal of the resource is to improve communication, align expectations and improve scientific understanding about study endpoints, biomarkers and related scientific terms. For example, the glossary aims to capture distinctions between biomarkers and clinical outcome assessments and describe their distinct roles in biomedical research, clinical practice and medical product development. The glossary is meant to be a resource that will continue to be updated and refined,” said Amy Abernethy, M.D. Ph.D., FDA’s principal deputy commissioner of food and drugs. “Today we are seeking public comment on this resource to help determine its utility, develop future iterations and identify best methods for conveying this information. Ultimately, we hope that this glossary will help in accelerating drug development and improving health outcomes for patients.”
Today the U.S. Food and Drug Administration issued a Federal Register notice, 21st Century Cures: Announcing the Establishment of the BEST Resource Taxonomy, to open a docket for public comment. In 2015, the FDA-NIH (National Institutes of Health) Joint Leadership Council identified the harmonization of terms used in translational science and medical product development as a priority need, with a focus on terms related to study endpoints and biomarkers. This resulted in the BEST glossary of terms. The FDA is seeking comments concerning the utility of BEST; including edits, additions and removal of terms along with a rationale supporting these proposed changes. Comments can also address the best approach for developing future iterations of the glossary. FDA has previously discussed taxonomy for biomarkers used in drug development at its public meeting on Drug Development Tool Process on December 11, 2018, and invited comment on the BEST taxonomy in guidance on the evidentiary framework for biomarker qualification published on December 12, 2018.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.