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Identifying Barriers and Practical Solutions to Conducting Site-Based Research in North America: Exploring Acute Heart Failure Trials As a Case Study.

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Date
2015-10
Authors
Ambrosy, Andrew P
Mentz, Robert J
Krishnamoorthy, Arun
Greene, Stephen J
Severance, Harry W
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Abstract
Although the prognosis of ambulatory heart failure (HF) has improved dramatically there have been few advances in the management of acute HF (AHF). Despite regional differences in patient characteristics, background therapy, and event rates, AHF clinical trial enrollment has transitioned from North America and Western Europe to Eastern Europe, South America, and Asia-Pacific where regulatory burden and cost of conducting research may be less prohibitive. It is unclear if the results of clinical trials conducted outside of North America are generalizable to US patient populations. This article uses AHF as a paradigm and identifies barriers and practical solutions to successfully conducting site-based research in North America.
Type
Journal article
Subject
Acute heart failure
Clinical trials
Site-based research
Acute Disease
Clinical Trials as Topic
Guideline Adherence
Heart Failure
Humans
North America
Research
Research Design
Permalink
https://hdl.handle.net/10161/11505
Published Version (Please cite this version)
10.1016/j.hfc.2015.07.002
Publication Info
Ambrosy, Andrew P; Mentz, Robert J; Krishnamoorthy, Arun; Greene, Stephen J; & Severance, Harry W (2015). Identifying Barriers and Practical Solutions to Conducting Site-Based Research in North America: Exploring Acute Heart Failure Trials As a Case Study. Heart Fail Clin, 11(4). pp. 581-589. 10.1016/j.hfc.2015.07.002. Retrieved from https://hdl.handle.net/10161/11505.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Greene

Stephen Greene

Assistant Professor of Medicine
I am a cardiologist with a clinical and research interest in heart failure. I take care of patients with various types of heart failure, including patients who are best treated with medications and patients who receive advanced therapies like heart transplantation and mechanical assist devices. I became a heart failure cardiologist to help patients manage their heart conditions and best achieve their goals for their health. I am strongly committed to helping patients thoroughly understand their
Mentz

Robert John Mentz

Associate Professor of Medicine
I am a cardiologist with a clinical and research interest in heart failure (going from Failure to Function), including advanced therapies such as cardiac transplantation and mechanical assist devices or “heart pumps." I serve our group as Chief of the Heart Failure Section. I became a heart failure cardiologist in order to help patients manage their chronic disease over many months and years. I consider myself strongly committed to compassionate patient care with a
Severance

Harry Wells Severance Jr.

Adjunct Assistant Professor in the Department of Medicine
Site Principle Investigator: PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) prospective, randomized, multi-center clinical trial:Principle Investigator - Duke E.D. Site - "Speed" Study. Pilot phase of Gusto IV. Investigating Abciximab (a GP IIb-IIIa inhibitor) in combination with rapid access to cardiac cath. Funded through Duke Clinical Research Institute. Multi-center trial. Principle Investigator - Project: proposed mechanisms for af
Alphabetical list of authors with Scholars@Duke profiles.
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