Overview
Biomarkers are measurable indicators of biological states or conditions, used to examine normal biological processes, pathogenic processes, or pharmacologic responses to therapeutic interventions. The National Institutes of Health (NIH) has established programs to support biomarker research and development. The World Health Organization (WHO) has recognized the importance of biomarkers. The development of biomarkers is a complex process, involving the identification of potential biomarkers, validation of biomarker performance, and regulatory approval. Biomarkers are used in clinical trials to develop new drugs and to monitor drug efficacy. The European Medicines Agency (EMA) provides funding and support for biomarker research and development. The Food and Drug Administration (FDA) regulates the use of biomarkers in clinical trials.