Author + information
- Received October 29, 2018
- Revision received February 3, 2019
- Accepted February 4, 2019
- Published online April 29, 2019.
- Mitchell A. Psotka, MD, PhDa,∗ (, )@mpsotka,
- Susan E. Ammon, RN, MS, FNPb,
- Mona Fiuzat, PharmDc,
- Biykem Bozkurt, MD, PhDd,
- Eugene S. Chung, MDe,
- Robert T. Cole, MDf,
- Stephen J. Greene, MDc,
- David Kraus, MDg,
- Bonnie Ky, MD, MSCEh,
- Colleen K. McIlvennan, DNP, ANPi,j,k,
- Palak Shah, MD, MSa,
- John R. Teerlink, MDl,m,
- Mary Norine Walsh, MDn,
- Mariell Jessup, MDo and
- Christopher M. O'Connor, MDa
- aAdvanced Heart Failure, Inova Heart and Vascular Institute, Falls Church, Virginia
- bSan Francisco, California
- cDuke Clinical Research Institute, Durham, North Carolina
- dDivision of Cardiology, Winters Center for Heart Failure Research, Baylor College of Medicine, Houston, Texas
- eCenter for Heart Failure Therapy and Transplantation, The Christ Hospital, Cincinnati, Ohio
- fDivision of Cardiology, Duke University School of Medicine, Durham, North Carolina
- gStern Cardiovascular Foundation, Memphis, Tennessee
- hPerelman School of Medicine, University of Pennsylvania Health System, Philadelphia, Pennsylvania
- iAdult and Child Center for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, Colorado
- jColorado Cardiovascular Outcomes Research Consortium, Denver, Colorado
- kDivision of Cardiology, University of Colorado School of Medicine, Aurora, Colorado
- lSchool of Medicine, University of California-San Francisco, San Francisco, California
- mSection of Cardiology, San Francisco Veterans Affairs Medical Center, San Francisco, California
- nSaint Vincent’s Heart Center, Indianapolis, Indiana
- oAmerican Heart Association, Dallas, Texas
- ↵∗Address for correspondence:
Dr. Mitchell A. Psotka, Inova Heart and Vascular Institute, 3300 Gallows Road, Falls Church, Virginia 22042.
Objectives This study sought to determine clinician and scientist involvement in heart failure (HF) clinical research and to describe the challenges of conducting clinical trials in the United States.
Background Improvements in the current capability, potential, and deficiencies of the HF clinical research infrastructure in the United States are needed in order to enhance efficiency and impact.
Methods The Heart Failure Society of America (HFSA) distributed an electronic survey regarding HF clinical trial activity for the purpose of understanding the barriers that exist to conducting high-quality HF clinical research.
Results Overall, 1,794 HFSA members were queried, and 434 members (24%) completed surveys, whereas a total of 7,589 individuals with interest in HF were queried, and 615 completed surveys. Of the respondents, 410 (67%) were actively engaged in HF research and 120 (20%) were interested in research. Most respondents, 270, were physicians (44%); 311 of the total (76% of the total and 80% of physicians) practiced in academic institutions; 333 respondents (81%) had served as principal investigators and 73 (18%) as site coordinators. Respondents active in clinical research usually participated in 1 to 5 trials and enrolled 1 to 20 patients annually. Institutional review board (IRB) approval typically required 3 months, and contract completion required 3 to 6 months per site. The greatest barriers to research were insufficient site budgets, delay in contracting, inability to find participants meeting trial entry criteria, and unavailability of qualified study coordinators.
Conclusions Many U.S. clinical research sites are constrained by budgetary, staffing, and contractual issues. The HFSA Research Network seeks to unify interested sites and deconstruct barriers to permit high-value HF research.
Supported by the Heart Failure Society of America. Dr. Psotka is a consultant for Amgen, Cytokinetics, and Roivant. Dr. Bozkurt has received funding through her institution from Novartis; is a consultant for Amgen and Lantheus; and is a member of the Clinical Endpoints Committee for Abbott. Dr. Ky has received funding from Roche and Pfizer. Dr. Chung is a consultant for Boston Scientific, Medtronic, and CardioMEMS; is a compensated speaker for Boston Scientific; and has received funding through his institution from Gambro, Medtronic, and Boston Scientific. Dr. Greene is supported by National Heart Lung and Blood Institute T32 post-doctoral training grant T32HL069749-14 and a Heart Failure Society of America/Emergency Medicine Foundation Acute Heart Failure Young Investigator Award funded by Novartis; and has received research support from Amgen and Novartis. Dr. McIlvennan has received support from the Heart Failure Society of America. Dr. Shah has received support from Merck and Haemonetics; has received grant funding from Merck, American Heart Association/Enduring Hearts, and Medtronic; and is a consultant for NuPulse CV and Ortho Clinical Diagnostics. Dr. Teerlink is a consultant for Amgen, Bayer, Cytokinetics, Novartis, and Stealth Health; has received funding from Abbott, Amgen, Bayer, Bristol-Myers Squibb, Novartis, and scPharma; has received research grants and personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cytokinetics, Medtronic, and St. Jude; and is a consultant for Abbott, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Cytokinetics, Medtronic, Merck, Novartis, and St. Jude Medical. Dr. O’Connor has received research funding from and is a consultant for ResMed, Merck, and Bristol-Myers Squibb; is a consultant for Stealth Peptides; and is a co-owner of Biscardia. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Barry Greenberg, MD, served as Guest Editor for this paper.
- Received October 29, 2018.
- Revision received February 3, 2019.
- Accepted February 4, 2019.
- 2019 American College of Cardiology Foundation
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