ABSTRACT
This chapter describes specific biomarker development activities of US-based consortia and provides some examples of semiquantitative metrics of their impact on the field, as well as highlight efforts to clarify the qualification process and also provides more efficient approaches to future biomarker development. The development of clinically relevant biomarkers is a time-consuming, data intensive and costly process. Confidence in the use of a biomarker in drug development often requires a broad consensus about what clinical outcomes the biomarker is correlated with and what the limits are to its use. The initial stage of biomarker development involves the identification of new biomarkers linked to a specific disease or disease trait. A literature search for biomarker use in clinical trials shows a consistent increase in articles each year from 2006 to 2016. The Food and Drug Administration Biomarker Qualification program reports the status of qualification programs at several stages prior to final qualification.
