FDA Seeks Input on Biomarker, Endpoint Glossary
Two-and-a-half years after its release, the US Food and Drug Administration (FDA) is asking for input from the public on the utility of its Biomarkers, EndpointS, and other Tools (BEST) glossary as it looks to refine the resource going forward.“Today we are seeking public comment on this resource to help determine its utility, develop future iterations and best identify methods for conveying this information. Ultimately, we hope that this glossary will help in accelerating drug development and improving health outcomes for patients,” said FDA Principal Deputy Commissioner Amy Abernethy.
Background
The effort to develop the BEST glossary stems from a recommendation by the FDA-NIH Joint Leadership Council in 2015 that identified establishing harmonized terms for use across translational science and drug development as a priority for the two agencies.
FDA and NIH released the BEST glossary the following year after the passage of the 21st Century Cures Act, which called for the creation of a “taxonomy for the classification of biomarkers (and related scientific concepts) for use in drug development.”
Since the glossary’s launch FDA has held a public meeting on the drug development tool process in December 2018, where it discussed a taxonomy for biomarkers. FDA also requested comments on the BEST taxonomy in draft guidance on biomarker qualification released alongside the public meeting.
Consultation
FDA says it hopes to receive input from drugmakers, academia and patient groups as the agency looks to improve upon the glossary in future iterations.
In the Federal Register notice announcing the consultation, FDA outlines four specific areas it is seeking comments on:
- “The utility of the BEST glossary;
- Specific proposed edits, including additions and removal of terms, with a rationale supporting these proposed edits;
- The best approach for developing future iterations of the glossary; and
- Questions pertaining to the BEST glossary that [commenters] would like FDA to address in future communications.”
Going forward, FDA says it hopes to elaborate on the terms covered in the glossary to ensure they remain relevant and are used consistently in drug development.
“The current phase of BEST comprises a glossary that clarifies use of important terms in the context of biomarkers and related scientific concepts and describes some of the hierarchical relationships, connections, and dependencies among the terms it contains,” FDA writes.
FDA, Federal Register Notice