Identifying Barriers and Practical Solutions to Conducting Site-Based Research in North America: Exploring Acute Heart Failure Trials As a Case Study.
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 articleSubject
Acute heart failureClinical trials
Site-based research
Acute Disease
Clinical Trials as Topic
Guideline Adherence
Heart Failure
Humans
North America
Research
Research Design
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https://hdl.handle.net/10161/11505Published Version (Please cite this version)
10.1016/j.hfc.2015.07.002Publication 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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Show full item recordScholars@Duke
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
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
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
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