Author + information
- Received March 15, 2016
- Revision received July 10, 2016
- Accepted July 12, 2016
- Published online October 25, 2016.
- W. Schuyler Jones, MDa,∗ (, )
- Matthew T. Roe, MD, MHSa,
- Elliott M. Antman, MDb,
- Mark J. Pletcher, MD, MPHc,
- Robert A. Harrington, MDd,
- Russell L. Rothman, MD, MPPe,
- William J. Oetgen, MD, MBAf,
- Sunil V. Rao, MDa,
- Mitchell W. Krucoff, MDa,
- Lesley H. Curtis, PhDa,
- Adrian F. Hernandez, MD, MHSa and
- Frederick A. Masoudi, MD, MSPHg
- aDepartment of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
- bTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
- cDivision of Clinical Epidemiology, Department of Epidemiology and Biostatistics, University of California, San Francisco, California
- dDepartment of Medicine, Stanford University School of Medicine, Stanford, California
- eDepartments of Medicine and Pediatrics, Vanderbilt University, Nashville, Tennessee
- fAmerican College of Cardiology, Washington, DC
- gDepartment of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado
- ↵∗Reprint requests and correspondence:
Dr. W. Schuyler Jones, Duke University Medical Center, P.O. Box 3330, Durham, North Carolina 27710.
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.
The National Heart, Lung, and Blood Institute initially funded the National Cardiovascular Research Infrastructure (NHLBI grant #1RC2HL101512-01 for SAFE-PCI for Women). The ADAPTABLE study is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (contract number ASP-1502-27079). Dr. Jones has received research grants from the Agency for Healthcare Research and Quality, AstraZeneca, American Heart Association, Bristol-Myers Squibb, Doris Duke Charitable Foundation, and PCORI; and has received honoraria/other support from the American College of Radiology and Daiichi-Sankyo. Dr. Roe has received research grants from Eli Lilly, Sanofi, Daiichi-Sankyo, Janssen Pharmaceuticals, Ferring Pharmaceuticals, MyoKardia, AstraZeneca, American College of Cardiology, American Heart Association, and Familial Hypercholesterolemia Foundation; and has served as a consultant for or received honoraria from PriMed, AstraZeneca, Boehringer Ingelheim, Merck, Amgen, MyoKardia, Eli Lilly, Daiichi-Sankyo, Quest Diagnostics, and Elsevier Publisher. Dr. Antman has received a research grant from Daiichi-Sankyo through his institution. Dr. Pletcher has received research grants from the National Institutes of Health (NIH) and PCORI. Dr. Harrington has received research grants and consultant/advisory fees from Merck; has received research grants from Jansen, CSL, GlaxoSmithKline, Portola, Regado, AstraZeneca, Sanofi, and The Medicines Company; has served as a consultant to The Medicines Company, Amgen, Gilead, and MyoKardia; has served on the science board of WebMD, Element Science, and Adverse Events; and has served on the Board of Directors of Scanadu Signal Path. Dr. Rothman has received research grants/contracts from the NIH, PCORI, and the Centers for Medicare and Medicaid Services; and has served as a consultant for EdLogics and Boehringer Ingelheim. Dr. Oetgen is the Executive Vice President of the American College of Cardiology (ACC). Dr. Rao has received a research grant from Bellerophon; and has served as a consultant for Medtronic, Boehringer Ingelheim, Merck, ZOLL, and Terumo Interventional Systems. Dr. Krucoff has received funding from Abbott Vascular, Acist Medical Systems, AngelMed Inc., Bellerophon Therapeutics, Boston Scientific, Epi-EP, Medtronic, Micelle Technologies Inc., OrbusNeich, St. Jude Medical, Terumo, and Volcano/Philips. Dr. Curtis has received research grants from GlaxoSmithKline, Novartis, Amgen, Boston Scientific, and Gilead. Dr. Hernandez has received research grants from the NIH, PCORI, Agency for Healthcare Research and Quality, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Merck, Novartis, and Portola Pharmaceuticals; and has served as a consultant for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Merck, and Novartis. Dr. Masoudi has received grants/research support from the NHLBI, ACC, PCORI, and the John. A. Hartford Foundation; and serves as an ACC Chief Science Officer (National Cardiovascular Data Registries) and member of the Board of Trustees. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 15, 2016.
- Revision received July 10, 2016.
- Accepted July 12, 2016.
- American College of Cardiology Foundation
- Central Illustration
- Current Challenges With Traditional Clinical Trials
- The Future of Innovative Cardiovascular Clinical Trials
- Registry-Based Clinical Trials
- What is Needed to Conduct Pragmatic Trials
- PCORI Established a Network of Networks
- ADAPTABLE: A PCORnet Pragmatic Clinical Trial
- The Path Forward