title: Transforming Drug Development in Heart Failure: Navigating the Regulatory Crossroads.
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (M.V.); Division of Cardiology, Stony Brook University, NY (J.B.); and Center for Cardiovascular Innovation, Northwestern University, Feinberg School of Medicine, Chicago, IL (M.G.).
authors.forename: Muthiah
authors.initials: M
authors.lastname: Vaduganathan
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (M.V.); Division of Cardiology, Stony Brook University, NY (J.B.); and Center for Cardiovascular Innovation, Northwestern University, Feinberg School of Medicine, Chicago, IL (M.G.).
authors.forename: Javed
authors.initials: J
authors.lastname: Butler
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (M.V.); Division of Cardiology, Stony Brook University, NY (J.B.); and Center for Cardiovascular Innovation, Northwestern University, Feinberg School of Medicine, Chicago, IL (M.G.). m-gheorghiade@northwestern.edu.
authors.forename: Mihai
authors.initials: M
authors.lastname: Gheorghiade
mesh_terms: D000818:Animals; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000379:methods; D033161:Government Regulation; D006333:Heart Failure / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D006801:Humans; D033181:Information Dissemination / Q000331:legislation & jurisprudence; D012107:Research Design / Q000331:legislation & jurisprudence; D018570:Risk Assessment; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D002317:Cardiovascular Agents
keywords: drugs trials; heart failure; randomized controlled trial