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

Ambrosy, Andrew P

Mentz, Robert J

Krishnamoorthy, Arun

Greene, Stephen J

Severance, Harry W

United States

2016-01-11T20:15:04Z

2015-10

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.

http://www.ncbi.nlm.nih.gov/pubmed/26462098

S1551-7136(15)00055-0

1551-7136

https://hdl.handle.net/10161/11505

eng

Elsevier BV

Heart Fail Clin

10.1016/j.hfc.2015.07.002

Acute heart failure

Clinical trials

Site-based research

Acute Disease

Clinical Trials as Topic

Guideline Adherence

Heart Failure

Humans

North America

Research

Research Design

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

Journal article

Mentz, Robert J|0000-0002-3222-1719

Greene, Stephen J|0000-0001-6912-7374

Severance, Harry W|0000-0001-6057-643X

http://www.ncbi.nlm.nih.gov/pubmed/26462098

581

589

4

Clinical Science Departments

Duke

Duke Clinical Research Institute

Institutes and Centers

Medicine

Medicine, Cardiology

School of Medicine

Published

11