Identifying Barriers and Practical Solutions to Conducting Site-Based Research in North America: Exploring Acute Heart Failure Trials As a Case Study.
Date
2015-10
Journal Title
Journal ISSN
Volume Title
Repository Usage Stats
views
downloads
Citation Stats
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
Department
Description
Provenance
Subjects
Citation
Permalink
Published Version (Please cite this version)
Publication Info
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.
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.
Collections
Scholars@Duke
Robert John Mentz
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 focus on quality of life and patient preference.
I am the Editor in Chief of the Journal of Cardiac Failure - The official journal of the Heart Failure Society of America.
My research interests are focused on treating co-morbid diseases in heart failure patients and improving outcomes across the cardiovascular spectrum through clinical trials and outcomes research. Below, you will find my specific research interests:
- Cardiometabolic disease
- Co-morbidity characterization (diabetes, sleep apnea, renal failure) in heart failure
- Phenotypic characterization and risk prognostication of patients with heart failure
- Role of surrogate and nonfatal endpoints in clinical heart failure trials
- Biomarkers in heart failure
- Novel pharmacological and non-pharmacological approaches to heart failure
- Improving site-based heart failure research
Stephen Greene
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 medical conditions and helping them make informed medical decisions aligned with their preferences.
My research interests are focused on strategies and therapies to improve outcomes and quality of life for patients with heart failure. This involves research through clinical trials and through examining data from real-world clinical practice. Below, you will find my specific research interests:
- Use and dosing of evidence-based heart failure medications
- Management of worsening heart failure outside the hospital
- Novel pharmacological and non-pharmacological approaches to heart failure
- Improving outcomes following a hospitalization for heart failure
- Surrogate and nonfatal endpoints in heart failure clinical trials
- Clinical trial design and operations
- Improving site-based heart failure research
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
Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.