Biomarkers in drug development

Abstract Biomarkers play important roles in the practice of medicine and all phases of drug development by providing information on patient status in the clinical setting and critical information on pharmacodynamic activity, efficacy, and safety throughout drug development. In some cases, biomarkers may even be used as surrogate endpoints for the basis for approval of a drug, rather than a direct measure of a clinical endpoint. Increased use of biomarkers has led to recent efforts to standardize nomenclature, assessment, and validation of biomarkers to further advance biomarker development and integration into drug development. In addition, recent technological advancements in instrumentation and data computation have transformed biomarker discovery and development. These advancements will likely have a major impact on the future of clinical trials, drug evaluation, and patient care.