title: Toward phase 4 trials in heart failure: A social and corporate responsibility of the medical profession.
abstract: Congestive heart failure (CHF) is a chronic condition, requiring polypharmacy, allied health supports and regular monitoring. All these factors are needed to ensure compliance and to deliver the positive outcomes demonstrated from randomized controlled trials. Unfortunately many centers around the world are unable to match trial level support. The outcomes for many communities are thus unclear. Research design factors in post-marketing surveillance to address this issue. Phase 4 studies is the name given to trials designed to obtain such community level data and thus address issues of external validity. CHF phase 4 studies are relatively underutilized. We feel the onus for this research lies with the health profession. In this commentary we provide arguments as to why phase 4 studies should be viewed as a social and corporate responsibility of health professional that care for clients with CHF.
authors.affiliation: Pupalan Iyngkaran, NT Medical School, Research Fellow and Senior Lecturer Flinders University, Darwin NT 0815, Australia.
authors.forename: Pupalan
authors.initials: P
authors.lastname: Iyngkaran
authors.affiliation: Pupalan Iyngkaran, NT Medical School, Research Fellow and Senior Lecturer Flinders University, Darwin NT 0815, Australia.
authors.forename: Glen S
authors.initials: GS
authors.lastname: Beneby
keywords: Clinical trial; Congestive heart failure; Corporate responsibility; Health system; Phase 4