caa a22 4500 605479011 CHVBK 20210128100408.0 cr unu---uuuuu 210128e20150701xx s 000 0 eng 10.1007/s10741-015-9473-z doi (NATIONALLICENCE)springer-10.1007/s10741-015-9473-z Site selection for heart failure clinical trials in the USA [Elektronische Daten] [Matthew Harinstein, Javed Butler, Stephen Greene, Gregg Fonarow, Norman Stockbridge, Christopher O'Connor, Marc Pfeffer, Mandeep Mehra, Scott Solomon, Clyde Yancy, Mona Fiuzat, Robert Mentz, Sean Collins, John McMurray, Muthiah Vaduganathan, Preston Dunnmon, Giuseppe Rosano, Wilfried Dinh, Frank Misselwitz, Robert Bonow, Mihai Gheorghiade] ABSTRACT: There are more than 1 million primary hospitalizations for heart failure (HF) annually in the USA alone, and post-discharge outcomes remain persistently poor despite available therapies and quality improvement initiatives. Recent international randomized clinical trials in hospitalized HF have repeatedly failed to improve this post-discharge event rate. A potential reason for this persistent lack of clinical trial success that has not previously received significant attention relates to site selection and the generally low level of patient enrollment from the USA. Only ~5% of US hospitals participate in clinical trials, and in four recent randomized trials of hospitalized HF, only one-third of patients were enrolled in North America. This poor participation among US centers has necessitated disproportionate enrollment from non-US sites. Regional variations in HF patient characteristics and clinical outcomes are well documented, and a lack of US patient representation in clinical trials limits the generalizability of results and presents obstacles for US regulatory agency approval. There are multiple impediments to successful US enrollment including a lack of incentive for investigators and institutions, the relative value unit-based compensation system, poor institutional framework for identification of appropriate patients, and increasing liability to conduct trials. In this manuscript, we specifically identify barriers to successful hospitalized HF clinical trial participation in the USA and suggest possible solutions. Springer Science+Business Media New York, 2015 Clinical trials nationallicence Site selection nationallicence Heart failure nationallicence United States nationallicence Outcomes nationallicence Harinstein Matthew Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut Butler Javed Division of Cardiology, Stony Brook University School of Medicine, Stony Brook, NY, USA aut Greene Stephen Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA aut Fonarow Gregg Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA aut Stockbridge Norman Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA aut O'Connor Christopher Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA aut Pfeffer Marc Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA aut Mehra Mandeep Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA aut Solomon Scott Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA aut Yancy Clyde Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA aut Fiuzat Mona Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA aut Mentz Robert Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA aut Collins Sean Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA aut McMurray John Institute of Cardiovascular and Medical Sciences, British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK aut Vaduganathan Muthiah Department of Medicine, Massachusetts General Hospital, Boston, MA, USA aut Dunnmon Preston Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA aut Rosano Giuseppe Division of Cardiology, IRCC San Raffaele, Rome, Italy aut Dinh Wilfried Global Drug Discovery, Clinical Sciences, Experimental Medicine, Bayer Pharma AG, Berlin, Germany aut Misselwitz Frank Global Drug Discovery, Clinical Sciences, Experimental Medicine, Bayer Pharma AG, Berlin, Germany aut Bonow Robert Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA aut Gheorghiade Mihai Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA aut Heart Failure Reviews Springer US; http://www.springer-ny.com 20/4(2015-07-01), 375-383 1382-4147 20:4<375 2015 20 10741 https://doi.org/10.1007/s10741-015-9473-z text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10741-015-9473-z text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Harinstein Matthew Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Butler Javed Division of Cardiology, Stony Brook University School of Medicine, Stony Brook, NY, USA aut NATIONALLICENCE 700 1- Greene Stephen Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA aut NATIONALLICENCE 700 1- Fonarow Gregg Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA aut NATIONALLICENCE 700 1- Stockbridge Norman Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA aut NATIONALLICENCE 700 1- O'Connor Christopher Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA aut NATIONALLICENCE 700 1- Pfeffer Marc Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA aut NATIONALLICENCE 700 1- Mehra Mandeep Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA aut NATIONALLICENCE 700 1- Solomon Scott Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA aut NATIONALLICENCE 700 1- Yancy Clyde Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA aut NATIONALLICENCE 700 1- Fiuzat Mona Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA aut NATIONALLICENCE 700 1- Mentz Robert Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA aut NATIONALLICENCE 700 1- Collins Sean Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA aut NATIONALLICENCE 700 1- McMurray John Institute of Cardiovascular and Medical Sciences, British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK aut NATIONALLICENCE 700 1- Vaduganathan Muthiah Department of Medicine, Massachusetts General Hospital, Boston, MA, USA aut NATIONALLICENCE 700 1- Dunnmon Preston Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA aut NATIONALLICENCE 700 1- Rosano Giuseppe Division of Cardiology, IRCC San Raffaele, Rome, Italy aut NATIONALLICENCE 700 1- Dinh Wilfried Global Drug Discovery, Clinical Sciences, Experimental Medicine, Bayer Pharma AG, Berlin, Germany aut NATIONALLICENCE 700 1- Misselwitz Frank Global Drug Discovery, Clinical Sciences, Experimental Medicine, Bayer Pharma AG, Berlin, Germany aut NATIONALLICENCE 700 1- Bonow Robert Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA aut NATIONALLICENCE 700 1- Gheorghiade Mihai Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA aut NATIONALLICENCE 773 0- Heart Failure Reviews Springer US; http://www.springer-ny.com 20/4(2015-07-01), 375-383 1382-4147 20:4<375 2015 20 10741