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.
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