Dr. Carrie Wolinetz is NIH’s Associate Director for Science Policy, and writes about biomedical research policy issues on her blog, Under the Poliscope.
Precise and clear communication across biological and clinical research disciplines supports efficient translation of results from basic research into applied therapeutics and interventions. Both the NIH and FDA are keenly interested in working together to help the biological and clinical research communities speak a common language, so that research results can be clearly understood by both groups.
This is especially true in considering the vocabulary used to describe measures of health, disease, or physiological processes. For example, “biomarkers,” “surrogate endpoints,” and “clinical outcome measures” are widely used in published research findings. The terms above mean different things; in order to build a solid foundation of research for precision medicine (and medicine in general), it is important that researchers are communicating consistently and that the wider community understands what published results actually mean. Inconsistent terminology undermines the strength of these tools.
We’d like to share a new resource focused on biomarkers, endpoints, and other related tools that we hope will assist researchers in the development of their research plans and reporting of research findings. Earlier this year, the NIH and FDA published an open access textbook: the Biomarkers, EndpointS, and Other Tools (BEST) Resource. BEST was developed by evaluating an extensive array of definitions — drawing from FDA guidance documents; the scientific literature; the 2010 Institute of Medicine study on the Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease; and a 2015 Brookings Institution meeting with academic and private sector stakeholders.
If your work involves the use of biomarkers or clinical outcomes, we hope you take a look at this resource and consider using it in a variety of contexts – reading and writing manuscripts, discussing your ideas with colleagues, and planning the next steps in your research. The glossary is intended to be a living document, with the goal of adding more terms and definitions based on your feedback. We welcome you to email the joint FDA-NIH Biomarker Working Group with your suggestions – including proposed edits. This input will be used by the Working Group to inform future editions of this glossary.
For additional perspectives on this resource, please see the recent JAMA article or blog in the FDA Voice. Many thanks to Pamela McInnes, Lisa McShane, and Holli Hamilton of NIH for their contributions to this blog.