2015
DOI: 10.4137/cmc.s18737
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Bedside–to-Bench Translational Research for Chronic Heart Failure: Creating an Agenda for Clients who do Not Meet Trial Enrollment Criteria

Abstract: Congestive heart failure (CHF) is a chronic condition usually without cure. Significant developments, particularly those addressing pathophysiology, mainly started at the bench. This approach has seen many clinical observations initially explored at the bench, subsequently being trialed at the bedside, and eventually translated into clinical practice. This evidence, however, has several limitations, importantly the generalizability or external validity. We now acknowledge that clinical management of CHF is mor… Show more

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Cited by 5 publications
(6 citation statements)
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“…Basic (Bench) Research: We have previously highlighted biomarkers, pharmaceuticals with extra class effects and genetics in the cardio-renal-metabolic axis as priorities [ 93 ]. It could be an avenue to fine-tune existing evidence to ensure greater external appeal or find new evidence to take to the bedside.…”
Section: Developing Evidence For a New Treatment Strategymentioning
confidence: 99%
“…Basic (Bench) Research: We have previously highlighted biomarkers, pharmaceuticals with extra class effects and genetics in the cardio-renal-metabolic axis as priorities [ 93 ]. It could be an avenue to fine-tune existing evidence to ensure greater external appeal or find new evidence to take to the bedside.…”
Section: Developing Evidence For a New Treatment Strategymentioning
confidence: 99%
“…‘Translation’, as defined by The National Center for Advancing Translational Sciences (NCATS), is the process that brings the bench observation into the clinical domain to help improve the health of individuals and their communities, and encompasses all facets from, diagnostics, therapeutics, to medical procedures and even behavioral changes. At the heart of all this is the search for efficacy, effectiveness and quality [ 1 , 2 , 15 - 18 ]. Box 1 explores these steps in greater detail.…”
Section: Phases and Cost Of Evidence Generationmentioning
confidence: 99%
“…It is our view that preclinical studies should be viewed twofold: firstly, studies that bring a novel therapy into the clinical domain (mainly industry); and secondly, studies that evolve from new hypothesis following post-marketing surveillance (mainly academia). This type of indication can form the basis for equivalence studies or expansion of an indication of drug within a class [ 15 , 16 , 26 - 33 ].…”
Section: Phases and Cost Of Evidence Generationmentioning
confidence: 99%
“…Phase IV trials, which involve postmarketing surveillance of the uncontrolled treatment of a patient population, are needed to advance understanding of external validity. [3][4][5] In this review, we have focused on patient demographics, diabetes mellitus (DM), chronic renal failure (CRF), and atrial fibrillation in CHF. Pathophysiological variations in responses to treatments are seen for the following factors: doses (eg, statin doses and Asian patients), class of agents used (eg, benefits of nitrates and hydralazine for CHF in African A Review of the External Validity of Clinical Trials with Beta-Blockers in Heart Failure American patients), 6 or a particular agent within a class (eg, the lack of effect of bucindolol in African American patients).…”
Section: Introductionmentioning
confidence: 99%
“…Phase IV trials, which involve postmarketing surveillance of the uncontrolled treatment of a patient population, are needed to advance understanding of external validity. 35…”
Section: Introductionmentioning
confidence: 99%