Editorial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Methodol. Dec 26, 2015; 5(4): 179-184
Published online Dec 26, 2015. doi: 10.5662/wjm.v5.i4.179
Toward phase 4 trials in heart failure: A social and corporate responsibility of the medical profession
Pupalan Iyngkaran, Glen S Beneby
Pupalan Iyngkaran, NT Medical School, Research Fellow and Senior Lecturer Flinders University, Darwin NT 0815, Australia
Glen S Beneby, Commonwealth of the Bahamas, 3rd and West Centerville, Nassau 999154, Bahamas
Author contributions: Iyngkaran P wrote the manuscript; Beneby GS edited and added in additional relevant points.
Conflict-of-interest statement: All co-authors have won independent and governmental research funding. Several members provide counsel to pharmaceuticals. None pose a conflict of interest for this short paper.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dr. Pupalan Iyngkaran, MBBS, FRACP, Consultant Cardiologist, NT Medical School, Research Fellow and Senior Lecturer Flinders University, PO Box 41326, Casuarina, Darwin NT 0815, Australia. gbeneby@batelnet.bs
Telephone: +61-88-9467488 Fax: +61-88-9467599
Received: December 10, 2014
Peer-review started: December 12, 2014
First decision: January 8, 2015
Revised: October 20, 2015
Accepted: October 23, 2015
Article in press: October 27, 2015
Published online: December 26, 2015
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.

Keywords: Clinical trial, Corporate responsibility, Health system, Congestive heart failure, Phase 4

Core tip: This commentary brings needed and timely attention to phase 4 or postmarketing surveillance. Only a handful of congestive heart failure (CHF) therapies have actually been studied in the community after the randomized controlled trial. In this millennium it is important we not only innovate and support trials of new therapies, but also ensure the therapies we are already using are effective for all patients. As drug discovery and randomised controlled trial evidence is often done by private sector pharmaceuticals, we thus feel the need to bring attention on treating health care teams to regularly generate efficacy and effectiveness data for the CHF treatments they prescribe.