title: 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.
authors.affiliation: Division of Cardiology, Duke University School of Medicine, 2301 Erwin Road Drive, Durham, NC 27710, USA. Electronic address: andrew.ambrosy@dm.duke.edu.
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Ambrosy
authors.affiliation: Division of Cardiology, Duke University School of Medicine, 2301 Erwin Road Drive, Durham, NC 27710, USA; Division of Cardiology, Duke Clinical Research Institute, 2301 Erwin Road Drive, Durham, NC 27710, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mentz
authors.affiliation: Division of Cardiology, Duke University School of Medicine, 2301 Erwin Road Drive, Durham, NC 27710, USA; Division of Cardiology, Duke Clinical Research Institute, 2301 Erwin Road Drive, Durham, NC 27710, USA.
authors.forename: Arun
authors.initials: A
authors.lastname: Krishnamoorthy
authors.affiliation: Division of Cardiology, Duke University School of Medicine, 2301 Erwin Road Drive, Durham, NC 27710, USA.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Greene
authors.affiliation: Erlanger Institute for Clinical Research, 973 E. 3rd St. Ste B1203, Chattanooga, TN 37403, USA.
authors.forename: Harry W
authors.initials: HW
authors.lastname: Severance
mesh_terms: D000208:Acute Disease; D002986:Clinical Trials as Topic / Q000191:economics* / Q000941:ethics / Q000331:legislation & jurisprudence*; D019983:Guideline Adherence; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D009656:North America; D012106:Research / Q000191:economics* / Q000331:legislation & jurisprudence*; D012107:Research Design / Q000592:standards* / Q000639:trends
keywords: Acute heart failure; Clinical trials; Site-based research