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<title><string language="fre"><![CDATA[Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable.
Should there be a position statement establishing rules for biomarker studies?]]></string></title>
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<string language="fre"><![CDATA[Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable.
Should there be a position statement establishing rules for biomarker studies?
John JARCHO, Boston, USA, NEJM
Rita REDBERG, San Francisco, USA, Arch Intern Med
Joseph LOSCALZO, Boston, USA, Circulation
Jagat NARULA, New York, USA, JACC imaging
Mona FIUZAT, Durham, USA, JACC-HF
John CLELAND, Hull, GBR, Former Eur J Heart Failure
Abstract : Debate led by Journal Editors: There are too many studies and the quality is variable.
Should there be a position statement establishing rules for biomarker studies?
The measurement of biomarkers for diagnosis and prognosis in heart disease has changed the fundamental way that patients are evaluated, and has led to a literal explosion of studies exploring both novel applications of established biomarkers as well as the discovery of newer biological markers. With the rise in interest in novel biomarkers has come a clear heterogeneity in the approach with which these potentially important tests have been studied, partially due to a lack of guidance as to nominal expectations for the approach for their evaluation. To this point, there is no consensus yet articulated with respect to the minimum expectations for which a new diagnostic or prognostic biomarker should be held to in order to clarify or reject their potential value. We recently proposed several standards to which novel biomarkers in heart failure should be held during their evaluation (Table) (1); these “rules” do not specifically apply to heart failure per se, and could thus theoretically serve as a starting point for determining the basic framework upon which the evaluation of novel applications of prior markers or the description of a frankly new biomarker.
1. The method by which a novel biomarker is judged (including and especially when compared to or in combination with other biomarkers) should be thorough: novel tests should be evaluated across a wide range of patients typical of the diagnosis for which it will be applied, and the statistical methods used to evaluate the biomarker (relative to clinical variables as well as other biomarkers) should be contemporary, rigorous, standardized and fair.
2. Measurement of a novel HF biomarker (e.g. in blood, urine or any easy obtainable tissue) should be easily achieved within a short period of time, provide acceptable accuracy and assays for its measurement should have defined biological variation and low analytical imprecision.
3. The biomarker should primarily reflect important (patho) physiological process(es) involved in HF presence and progression; use of biomarkers reflective of disease but originating outside the myocardium is acceptable as long as such a biomarker provides independently useful information involved in the diagnosis, prognosis, progression or therapy of HF syndromes.
4. The biomarker must provide clinically useful information for caregivers (physician, nurses, patient and others) to more swiftly and reliably establish/reject a diagnosis, to more accurately estimate prognosis, or to inform more successful therapeutic strategies. The information from such a biomarker should not recapitulate clinical information already available at the bedside, and must be additional to other biomarkers.
L’auteur n’a pas transmis de conflit d’intérêt concernant les données diffusées dans cette vidéo ou publiées dans la référence citée.
9th Global Cardiovascular Clinical Trialists Forum • Paris 2012 
WHAT IS THE OPTIMAL DESIGN FOR BIOMARKER STUDIES?
Chairpersons: Jim JANUZZI, Boston, USA - Faiez ZANNAD, Nancy, FRA
Réalisation, production : Canal U/3S et CERIMES
Keyword : Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, cardiovascular pharmacology, biomarker]]></string></description>
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NOTE:FIUZAT Mona, Durham, USA&lt;br&gt;Dr. Fiuzat is a Senior Research Associate in the Heart Failure Research Program at Duke University and Assistant Professor of Medicine in the Division of Clinical Pharmacology. She is also the Managing Deputy Editor of the new JACC-Heart Failure Journal. Dr. Fiuzat has worked at Solvay Pharmaceuticals and SmithKline Beecham Pharmaceuticals and was the Director of Clinical Operations and Development at ARCA biopharma, Inc. Her prior work experience included filing an NDA for the first proposed pharmacogenetically targeted heart failure drug and writing protocol and study development for Phase I, II and III studies, in both adults and pediatrics. Dr. Fiuzat’s clinical research experience has been in cardiovascular trials, with a focus on pharmacogenetics in heart failure. She is the Operational Leader of the PROTECT Publications Committee and a liaison for industry sponsors of clinical trials. Additionally, she has participated in the preparation for Cardio-renal Advisory Committee presentations to the FDA on behalf of drug sponsors. Dr. Fiuzat completed undergraduate training at Clemson University and received her PharmD at Mercer University School of Pharmacy. 
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