title: Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective.
abstract: Over the past decade, personalized medicine has received considerable attention from researchers, drug developers, and regulatory agencies. Personalized medicine includes identifying patients most likely to benefit and those most likely to experience adverse reactions in response to a drug, and tailoring therapy based on pharmacokinetics or pharmacodynamic response, as well. Perhaps most exciting is finding ways to identify likely responders through genetic, proteomic, or other tests, so that only likely responders will be treated. However, less precise methods such as identifying historical, demographic, or other indicators of increased or reduced responsiveness are also important aspects of personalized medicine. The cardiovascular field has not used many genetic or proteomic markers, but has regularly used prognostic variables to identify likely responders. The development of biomarker-based approaches to personalized medicine in cardiovascular disease has been challenging, in part, because most cardiovascular therapies treat acquired syndromes, such as acute coronary syndrome and heart failure, which develop over many decades and represent the end result of several pathophysiological mechanisms. More precise disease classification and greater understanding of individual variations in disease pathology could drive the development of targeted therapeutics. Success in designing clinical trials for personalized medicine will require the selection of patient populations with attributes that can be targeted or that predict outcome, and the use of appropriate enrichment strategies once such attributes are identified. Here, we describe examples of personalized medicine in cardiovascular disease, discuss its impact on clinical trial design, and provide insight into the future of personalized cardiovascular medicine from a regulatory perspective.
authors.affiliation: From Office of New Drugs (A.B., M.R., N.S., R.T., E.F.U.) and Office of Clinical Pharmacology (R.M., M.P., R.N.S.), Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Alison
authors.initials: A
authors.lastname: Blaus
authors.affiliation: From Office of New Drugs (A.B., M.R., N.S., R.T., E.F.U.) and Office of Clinical Pharmacology (R.M., M.P., R.N.S.), Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Rajanikanth
authors.initials: R
authors.lastname: Madabushi
authors.affiliation: From Office of New Drugs (A.B., M.R., N.S., R.T., E.F.U.) and Office of Clinical Pharmacology (R.M., M.P., R.N.S.), Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Michael
authors.initials: M
authors.lastname: Pacanowski
authors.affiliation: From Office of New Drugs (A.B., M.R., N.S., R.T., E.F.U.) and Office of Clinical Pharmacology (R.M., M.P., R.N.S.), Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Martin
authors.initials: M
authors.lastname: Rose
authors.affiliation: From Office of New Drugs (A.B., M.R., N.S., R.T., E.F.U.) and Office of Clinical Pharmacology (R.M., M.P., R.N.S.), Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. robert.schuck@fda.hhs.gov.
authors.forename: Robert N
authors.initials: RN
authors.lastname: Schuck
authors.affiliation: From Office of New Drugs (A.B., M.R., N.S., R.T., E.F.U.) and Office of Clinical Pharmacology (R.M., M.P., R.N.S.), Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Norman
authors.initials: N
authors.lastname: Stockbridge
authors.affiliation: From Office of New Drugs (A.B., M.R., N.S., R.T., E.F.U.) and Office of Clinical Pharmacology (R.M., M.P., R.N.S.), Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Robert
authors.initials: R
authors.lastname: Temple
authors.affiliation: From Office of New Drugs (A.B., M.R., N.S., R.T., E.F.U.) and Office of Clinical Pharmacology (R.M., M.P., R.N.S.), Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Ellis F
authors.initials: EF
authors.lastname: Unger
mesh_terms: D015415:Biomarkers; D001711:Biotransformation / Q000235:genetics; D002309:Cardiology / Q000331:legislation & jurisprudence / Q000639:trends; D002317:Cardiovascular Agents / Q000493:pharmacokinetics / Q000494:pharmacology; D002986:Clinical Trials as Topic; D004347:Drug Interactions; D004348:Drug Labeling; D005544:Forecasting; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000706:statistics & numerical data; D018579:Patient Selection; D057285:Precision Medicine / Q000639:trends*; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D002317:Cardiovascular Agents
keywords: biological markers; cardiology; clinical trial; individualized medicine; pharmacogenetics