title: Site selection for heart failure clinical trials in the USA.
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.
authors: Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
authors: Matthew E
authors: ME
authors: Harinstein
authors: Javed
authors: J
authors: Butler
authors: Stephen J
authors: SJ
authors: Greene
authors: Gregg C
authors: GC
authors: Fonarow
authors: Norman L
authors: NL
authors: Stockbridge
authors: Christopher M
authors: CM
authors: O'Connor
authors: Marc A
authors: MA
authors: Pfeffer
authors: Mandeep R
authors: MR
authors: Mehra
authors: Scott D
authors: SD
authors: Solomon
authors: Clyde W
authors: CW
authors: Yancy
authors: Mona
authors: M
authors: Fiuzat
authors: Robert J
authors: RJ
authors: Mentz
authors: Sean P
authors: SP
authors: Collins
authors: John J V
authors: JJ
authors: McMurray
authors: Muthiah
authors: M
authors: Vaduganathan
authors: Preston M
authors: PM
authors: Dunnmon
authors: Giuseppe M C
authors: GM
authors: Rosano
authors: Wilfried
authors: W
authors: Dinh
authors: Frank
authors: F
authors: Misselwitz
authors: Robert O
authors: RO
authors: Bonow
authors: Mihai
authors: M
authors: Gheorghiade
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D005260:Female; D006333:Heart Failure / Q000628:therapy*; D006760:Hospitalization; D006801:Humans; D008297:Male; D018579:Patient Selection; D014481:United States
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