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Site selection for heart failure clinical trials in the USA
Harinstein, Matthew E. Butler, Javed Greene, Stephen J. Fonarow, Gregg C. Stockbridge, Norman L. O'Connor, Christopher M. Pfeffer, Marc A. Mehra, Mandeep R. Solomon, Scott D. Yancy, Clyde W.
Harinstein, Matthew E.
Butler, Javed
Greene, Stephen J.
Fonarow, Gregg C.
Stockbridge, Norman L.
O'Connor, Christopher M.
Pfeffer, Marc A.
Mehra, Mandeep R.
Solomon, Scott D.
Yancy, Clyde W.
Author
Harinstein, Matthew E.
Butler, Javed
Greene, Stephen J.
Fonarow, Gregg C.
Stockbridge, Norman L.
O'Connor, Christopher M.
Pfeffer, Marc A.
Mehra, Mandeep R.
Solomon, Scott D.
Yancy, Clyde W.
Fiuzat, Mona
Mentz, Robert J.
Collins, Sean P.
McMurray, John J. V.
Vaduganathan, Muthiah
Dunnmon, Preston M.
Rosano, Giuseppe M. C.
Dinh, Wilfried
Misselwitz, Frank
Bonow, Robert O.
Gheorghiade, Mihai
Butler, Javed
Greene, Stephen J.
Fonarow, Gregg C.
Stockbridge, Norman L.
O'Connor, Christopher M.
Pfeffer, Marc A.
Mehra, Mandeep R.
Solomon, Scott D.
Yancy, Clyde W.
Fiuzat, Mona
Mentz, Robert J.
Collins, Sean P.
McMurray, John J. V.
Vaduganathan, Muthiah
Dunnmon, Preston M.
Rosano, Giuseppe M. C.
Dinh, Wilfried
Misselwitz, Frank
Bonow, Robert O.
Gheorghiade, Mihai
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.
Keywords
clinical trials, site selection, heart failure, United States, outcomes
Date
2015
Type
Journal article
Journal
Heart Failure Reviews
Book
Volume
20
Issue
4
Page Range
375-383
Article Number
ACU Department
Collections
Relation URI
Source URL
Event URL
Open Access Status
License
File Access
Controlled