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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:REDBERG Rita, San Francisco, USA&lt;br&gt;Rita F. Redberg, MD, MSc, has been a cardiologist and Professor of Medicine at the University of California, San Francisco since 1990. Dr. Redberg is currently the Chief Editor of Archives of Internal Medicine and has spearheaded the journal’s new focus on health care reform and “less is more”, which highlights areas of health care with no known benefit and definite risks. Her research interests are in the area of health policy and technology assessment focusing on how evidence relates to FDA approval, insurance coverage and medical guidelines and practice, particularly in the area of medical devices. Dr. Redberg is a member of the Medicare Payment Advisory Commission, which advises Congress on Medicare payment issues. She also served on the Medicare Evidence, Development and Coverage Advisory Committee from 2003- 2006 and was reappointed in 2012 as Chair of MEDCAC. Dr Redberg is a member of the California Technology Assessment Forum, the Medical Policy Technology and Advisory Committee, and the Food and Drug Administration Cardiovascular Devices Expert Panel, and is a consultant for the Center for Medical Technology Policy. She gave Congressional testimony four times in 2011 in hearings related to the issue of balancing safety and innovation in medical device approvals Dr. Redberg worked in the office of Senator Hatch and with the Senate Judiciary Committee on FDA-related matters during her tenure as a Robert Wood Johnson Health Policy Fellow, 2003-2006. Dr. Redberg was a member of the Institute of Medicine’s Learning Health Care Committee, which produced the report Best Care at Lower Cost in September 2012. She chaired the AHA/ACC Writing Group on Primary Prevention Performance Measures and is a member of the American College of Cardiology’s (ACC) Clinical Quality Committee and serves on the Quality in Technology Work Group. She does comparative effectiveness research, and serves on the American College of Cardiology’s Comparative Effectiveness Work Group, represents the ACC on the Institute of Clinical and Economic Review Advisory Board and serves on other ACC Committees, including several on appropriate use of cardiac imaging. She was honored by receiving the Women’s Day Red Dress Award in 2011 for her leadership in the area of heart disease in women. Dr. Redberg graduated from Cornell University and the University of Pennsylvania Medical School and has a Master of Science in Health Policy and Administration from the London School of Economics. 
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