title: The Changing Landscape of Randomized Clinical Trials in Cardiovascular Disease.
abstract: Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovascular disease around the world. Traditional clinical trials are increasingly challenging due to rising costs, increasing complexity and length, and burdensome institutional and regulatory requirements. This review will examine the current landscape of cardiovascular clinical trials in the United States, highlight recently conducted registry-based clinical trials, and discuss the potential attributes of the recently launched pragmatic clinical trial by the Patient-Centered Outcomes Research Institute's National Patient-Centered Clinical Research Network, called the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing the Benefits and Long-term Effectiveness) trial.
authors.affiliation: Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. Electronic address: schuyler.jones@duke.edu.
authors.forename: W Schuyler
authors.initials: WS
authors.lastname: Jones
authors.affiliation: Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Roe
authors.affiliation: TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Elliott M
authors.initials: EM
authors.lastname: Antman
authors.affiliation: Division of Clinical Epidemiology, Department of Epidemiology and Biostatistics, University of California, San Francisco, California.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Pletcher
authors.affiliation: Department of Medicine, Stanford University School of Medicine, Stanford, California.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.affiliation: Departments of Medicine and Pediatrics, Vanderbilt University, Nashville, Tennessee.
authors.forename: Russell L
authors.initials: RL
authors.lastname: Rothman
authors.affiliation: American College of Cardiology, Washington, DC.
authors.forename: William J
authors.initials: WJ
authors.lastname: Oetgen
authors.affiliation: Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.affiliation: Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
authors.affiliation: Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Lesley H
authors.initials: LH
authors.lastname: Curtis
authors.affiliation: Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Adrian F
authors.initials: AF
authors.lastname: Hernandez
authors.affiliation: Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Frederick A
authors.initials: FA
authors.lastname: Masoudi
mesh_terms: D002318:Cardiovascular Diseases / Q000628:therapy*; D006801:Humans; D064792:Pragmatic Clinical Trials as Topic; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012042:Registries; D014481:United States
keywords: Patient-Centered Outcomes Research Institute; aspirin; coronary artery disease; pragmatic clinical trial