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dc.contributor.authorIyngkaran, P.
dc.contributor.authorLiew, D.
dc.contributor.authorMcDonald, P.
dc.contributor.authorThomas, M.
dc.contributor.authorReid, Christopher
dc.contributor.authorChew, D.
dc.contributor.authorHare, D.
dc.date.accessioned2017-01-30T12:01:51Z
dc.date.available2017-01-30T12:01:51Z
dc.date.created2016-09-27T09:52:11Z
dc.date.issued2016
dc.date.submitted2016-09-27
dc.identifier.citationIyngkaran, P. and Liew, D. and McDonald, P. and Thomas, M. and Reid, C. and Chew, D. and Hare, D. 2016. Phase 4 studies in heart failure - What is done and what is needed?. Current Cardiology Reviews. 12 (3): pp. 216-230.
dc.identifier.urihttp://hdl.handle.net/20.500.11937/17439
dc.identifier.doi10.2174/1573403X12666160606121458
dc.description.abstract

© 2016 Bentham Science Publishers.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.

dc.titlePhase 4 studies in heart failure - What is done and what is needed?
dc.typeJournal Article
dcterms.dateSubmitted2016-09-27
dcterms.source.volume12
dcterms.source.number3
dcterms.source.startPage216
dcterms.source.endPage230
dcterms.source.issn1573-403X
dcterms.source.titleCurrent Cardiology Reviews
curtin.digitool.pid245714
curtin.pubStatusPublished
curtin.refereedTRUE
curtin.departmentDepartment of Health Policy and Management
curtin.identifier.scriptidPUB-VC-ORD-SA-06174
curtin.identifier.elementsidELEMENTS-133562
curtin.accessStatusFulltext not available


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