Site selection for heart failure clinical trials in the USA
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| 024 | 7 | 0 | |a 10.1007/s10741-015-9473-z |2 doi |
| 035 | |a (NATIONALLICENCE)springer-10.1007/s10741-015-9473-z | ||
| 245 | 0 | 0 | |a Site selection for heart failure clinical trials in the USA |h [Elektronische Daten] |c [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] |
| 520 | 3 | |a 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. | |
| 540 | |a Springer Science+Business Media New York, 2015 | ||
| 690 | 7 | |a Clinical trials |2 nationallicence | |
| 690 | 7 | |a Site selection |2 nationallicence | |
| 690 | 7 | |a Heart failure |2 nationallicence | |
| 690 | 7 | |a United States |2 nationallicence | |
| 690 | 7 | |a Outcomes |2 nationallicence | |
| 700 | 1 | |a Harinstein |D Matthew |u Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA |4 aut | |
| 700 | 1 | |a Butler |D Javed |u Division of Cardiology, Stony Brook University School of Medicine, Stony Brook, NY, USA |4 aut | |
| 700 | 1 | |a Greene |D Stephen |u Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA |4 aut | |
| 700 | 1 | |a Fonarow |D Gregg |u Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA |4 aut | |
| 700 | 1 | |a Stockbridge |D Norman |u Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA |4 aut | |
| 700 | 1 | |a O'Connor |D Christopher |u Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA |4 aut | |
| 700 | 1 | |a Pfeffer |D Marc |u Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA |4 aut | |
| 700 | 1 | |a Mehra |D Mandeep |u Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA |4 aut | |
| 700 | 1 | |a Solomon |D Scott |u Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA |4 aut | |
| 700 | 1 | |a Yancy |D Clyde |u Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA |4 aut | |
| 700 | 1 | |a Fiuzat |D Mona |u Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA |4 aut | |
| 700 | 1 | |a Mentz |D Robert |u Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA |4 aut | |
| 700 | 1 | |a Collins |D Sean |u Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA |4 aut | |
| 700 | 1 | |a McMurray |D John |u Institute of Cardiovascular and Medical Sciences, British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK |4 aut | |
| 700 | 1 | |a Vaduganathan |D Muthiah |u Department of Medicine, Massachusetts General Hospital, Boston, MA, USA |4 aut | |
| 700 | 1 | |a Dunnmon |D Preston |u Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA |4 aut | |
| 700 | 1 | |a Rosano |D Giuseppe |u Division of Cardiology, IRCC San Raffaele, Rome, Italy |4 aut | |
| 700 | 1 | |a Dinh |D Wilfried |u Global Drug Discovery, Clinical Sciences, Experimental Medicine, Bayer Pharma AG, Berlin, Germany |4 aut | |
| 700 | 1 | |a Misselwitz |D Frank |u Global Drug Discovery, Clinical Sciences, Experimental Medicine, Bayer Pharma AG, Berlin, Germany |4 aut | |
| 700 | 1 | |a Bonow |D Robert |u Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA |4 aut | |
| 700 | 1 | |a Gheorghiade |D Mihai |u Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA |4 aut | |
| 773 | 0 | |t Heart Failure Reviews |d Springer US; http://www.springer-ny.com |g 20/4(2015-07-01), 375-383 |x 1382-4147 |q 20:4<375 |1 2015 |2 20 |o 10741 | |
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| 950 | |B NATIONALLICENCE |P 856 |E 40 |u https://doi.org/10.1007/s10741-015-9473-z |q text/html |z Onlinezugriff via DOI | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Harinstein |D Matthew |u Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Butler |D Javed |u Division of Cardiology, Stony Brook University School of Medicine, Stony Brook, NY, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Greene |D Stephen |u Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Fonarow |D Gregg |u Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Stockbridge |D Norman |u Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a O'Connor |D Christopher |u Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Pfeffer |D Marc |u Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Mehra |D Mandeep |u Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Solomon |D Scott |u Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Yancy |D Clyde |u Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Fiuzat |D Mona |u Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Mentz |D Robert |u Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Collins |D Sean |u Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a McMurray |D John |u Institute of Cardiovascular and Medical Sciences, British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Vaduganathan |D Muthiah |u Department of Medicine, Massachusetts General Hospital, Boston, MA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Dunnmon |D Preston |u Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Rosano |D Giuseppe |u Division of Cardiology, IRCC San Raffaele, Rome, Italy |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Dinh |D Wilfried |u Global Drug Discovery, Clinical Sciences, Experimental Medicine, Bayer Pharma AG, Berlin, Germany |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Misselwitz |D Frank |u Global Drug Discovery, Clinical Sciences, Experimental Medicine, Bayer Pharma AG, Berlin, Germany |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Bonow |D Robert |u Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Gheorghiade |D Mihai |u Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, Chicago, IL, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 773 |E 0- |t Heart Failure Reviews |d Springer US; http://www.springer-ny.com |g 20/4(2015-07-01), 375-383 |x 1382-4147 |q 20:4<375 |1 2015 |2 20 |o 10741 | ||