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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2015-10
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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.
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Ambrosy, Andrew P, Robert J Mentz, Arun Krishnamoorthy, Stephen J Greene and Harry W Severance (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.
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Scholars@Duke
Harry Wells Severance
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 afferent pain transmission from myocardial cells to pain centers. Purpose is to identify potential biochemical markers for early anginal presentations. Funded: grants received from Merck & Co. and Roche-Boehringer-Mannheim. Pilot phase paper - in preparation.
Other Interest Areas:
Blasts/Ballistics
Wounding and medical management of penetrating injuries derived from firearms and blast-related injuries.
Impact of Observation/short-stay strategies on clinical care and inpatient/outpatient systems.
Impact of Emerging Viral Threats on clinical management and social/economic/political systems,
Acute Cardiology - Chest Pain Presentations
Evolving Technology and AI in improving clinical care/management
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