Generic placeholder image

Current Cardiology Reviews

Editor-in-Chief

ISSN (Print): 1573-403X
ISSN (Online): 1875-6557

Review Article

Phase 4 Studies in Heart Failure - What is Done and What is Needed?

Author(s): Pupalan Iyngkaran, Danny Liew, Peter McDonald, Merlin C. Thomas, Christopher Reid, Derek Chew and David L. Hare

Volume 12, Issue 3, 2016

Page: [216 - 230] Pages: 15

DOI: 10.2174/1573403X12666160606121458

Price: $65

Abstract

Congestive heart failure (CHF) therapeutics is generated through a well-described evidence generating process. Phases 1 – 3 of this process are required prior to approval and widespread clinical use. Phase 3 in almost all cases is a methodologically sound randomized controlled trial (RCT). After this phase it is generally accepted that the treatment has a significant, independent and prognostically beneficial effect on the pathophysiological process. A major criticism of RCTs is the population to whom the result is applicable. When this population is significantly different from the trial cohort the external validity comes into question. Should the continuation of the evidence generating process continue these problems might be identified. Post marketing surveillance through phase 4 and comparative effectiveness studies through phase 5 trials are often underperformed in comparison to the RCT. These processes can help identify remote adverse events and define new hypotheses for community level benefits. This review is aimed at exploring the post-marketing scene for CHF therapeutics from an Australian health system perspective. We explore the phases of clinical trials, the level of evidence currently available and options for ensuring greater accountability for community level CHF clinical outcomes.

Keywords: Clinical Trial, Congestive heart failure, Drug Surveillance, Review, Phase IV, Post-marketing Surveillance.

Graphical Abstract

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy