Heart Failure Site-Based Research in the United States: Results of the Heart Failure Society of America Research Network Survey

• Type of Material: Article
• Authors: Mitchell A. Psotka, Inova Heart and Vascular Institute; Susan E. Ammon, None; Mona Fiuzat, Duke Clinical Research Institute; Biykem Bozkurt, Baylor College of Medicine; Eugene S. Chung, The Christ Hospital - Cincinnati; Robert Cole, Emory University; Stephen J. Greene, Duke Clinical Research Institute; David Kraus, Stern Cardiovascular Foundation; Bonnie Ky, University of Pennsylvania; Colleen K. McIlvennan, University of Colorado; Palak Shah, Inova Heart and Vascular Institute; John R. Teerlink, UCSF School of Medicine; Mary Norine Walsh, St. Vincent Heart Center of Indiana; Mariell Jessup, American Heart Association; Christopher M. O'Connor, Inova Heart and Vascular Institute
• Language: English
• Date: 2019-05-01
• Publisher: Emory University Libraries
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2019 the American College of Cardiology Foundation. Published by Elsevier.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jchf.2019.02.008
• Title of Journal or Parent Work: JACC: Heart Failure
• Volume: 7
• Issue: 5
• Start Page: 431
• End Page: 438
• Grant/Funding Information: This research was funded by the Heart Failure Society of America.
• Keywords: United States; Humans; Contracts; Heart Failure; Research Personnel; Biomedical Research; Cross-Sectional Studies; Time Factors; Ethics Committees, Research; Nurses; Nurse Practitioners; Physicians; heart failure clinical research; Patient Selection; Clinical Trials as Topic; site-based research; research network; Research Support as Topic; Surveys and Questionnaires; Academic Medical Centers; clinical trials; Societies, Medical
• Research Categories: Health Sciences, Nursing; Health Sciences, Medicine and Surgery; Health Sciences, Health Care Management

Abstract

OBJECTIVES: This study aimed 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 (US). BACKGROUND: Improvements in the current capability, potential, and deficiencies of the HF clinical research infrastructure in the US are needed to enhance efficiency and impact. METHODS: The Heart Failure Society of America (HFSA) distributed an electronic survey regarding HF clinical trial activity purposed to understand the limitations to conduction of high-quality HF clinical research. RESULTS: Overall 1794 HFSA members were queried and 434 (24%) completed surveys, while 7589 total individuals with interest in HF were queried and 615 completed surveys. Of respondents, 410 (67%) were actively engaged in HF research and 120 (20%) were interested in research. Most respondents were physicians 270 (44%); 311 (76% of the total and 80% of physicians) practiced at academic institutions, 333 (81%) had served as principal investigators, and 73 (18%) as site coordinators. Respondents active in clinical research usually participated in 1–5 trials and enrolled 1–20 patients annually. Institutional review board (IRB) approval typically required 3 months and contract completion 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 US 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.