Key result
Phase 4 studies in congestive heart failure should be viewed as a social and corporate responsibility of health professionals to address issues of external validity.
The authors argue that phase 4 studies in heart failure are underutilized and should be viewed as a social and corporate responsibility of health professionals to ensure external validity of trial outcomes.
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.
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Iyngkaran et al. (2015) conducted an editorial in Congestive heart failure (CHF). Phase 4 trials was evaluated. Phase 4 studies in congestive heart failure should be viewed as a social and corporate responsibility of health professionals to address issues of external validity.
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