FDA-NIH BEST Biomarker Glossary Now Available

FDA-NIH BEST Biomarker Glossary cover

Precise, clear communication across all scientific research disciplines is crucial for more efficient translational of laboratory discoveries into new treatments for patients. To this end, NIH and the Food and Drug Administration (FDA) recently published an open access textbook: the Biomarkers, EndpointS and other Tools (BEST) Resource. NCATS’ Pamela McInnes, D.D.S., M.Sc. (Dent.), Holli Hamilton, M.D., and Monica Shah, M.D., M.H.S., M.S.J., as well as the National Cancer Institute’s Lisa McShane, Ph.D., represented NIH on the FDA-NIH Joint Leadership Council whose members collectively identified the need for and then developed this new resource.

The first phase of BEST comprises a glossary that clarifies important definitions, captures the distinction between biomarkers and clinical assessments, and describes some of the hierarchical relationships, connections, and dependencies among the terms. NIH and FDA plan to use the BEST Resource glossary when communicating about biomarkers to help ensure a consistent use of terms and a common understanding of issues.

For more information, see NIH’s Under the PoliscopeJAMA and FDA Voice.