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<title><string language="fre"><![CDATA[Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Post approval and registry studies (Ileana PIÑA)]]></string></title>
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<string language="fre"><![CDATA[MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012
THE DEVICE THERAPY TRIALISTS WORKSHOP
Chairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USA
Webcast: Tariq AHMAD, Durham, USA
Device trial methodology, regulatory and implementation issues
Advances in interventional medical devices are increasingly affecting cardiovascular therapy, just as pharmacological innovation did the generation before. Yet, designing and conducting a device trial is challenging and drug trial designs may not necessarily be applied fully to device trials.
? Although there is increasing recognition that this development process substantially differs from that for drugs, how much device trial methodology may deviate from drug trial methodology is a matter of discussion.
? Regulation works differently for drugs, devices, and procedures, and there are wide international variations. Although progressively moving toward some alignment, currently, in Europe, industry needs only to fulfill the (light) criteria of “CE” mark before approval.
General sale of devices may be permitted on the basis of proof of safety, rather than of efficacy or effectiveness. In any case, reimbursement claims may require collecting evidence in outcome cost-effectiveness trials. Regulators and commercial bodies should seek consensus.
? Innovation is led by device industry which is facing the economic challenge of bringing innovation to the market in a very competitive environment. Multi sponsored trials and the cooperation with public funders may be instrumental in improving knowledge production for a better device therapy.
? Interpretation of trial results, and consequently therapy adoption, is another challenge. The strength of evidence is not necessarily the main driver for adoption. Coronary angioplasty in stable CAD is widely adopted while, despite evidence for a beneficial effect of device therapy in heart failure, only a minority of eligible patients is currently offered these options.
? Beyond trials aimed at evaluating safety, effectiveness and approval, trials that establish the value of a therapy and hence support utilization in clinical practice are most needed.
The aim of this session is to contribute to identifying and promoting innovative, cooperative and practical solutions that may help filling the gaps between device and drug trials, between CE mark and FDA regulations and between generating evidence and practical implementations.
Session program:
How much one could deviate from “randomized - controlled” trials?
• Non randomized and/or non-blinded trials: When can they be trusted, what can help them to be “acceptable”?
Speaker: Stuart POCOCK, London, GBR
• Options of and alternatives to the “control group” in device trials
Speaker: William T. ABRAHAM, Columbus, USA
• Industry perspective
Speakers: Rob KIEVAL, CVRx, USA - Holger WOEHRLE, ResMed, GER
Approvability issues: Pathway to a more global device approval process
Speaker: Ileana PIÑA, New York, USA
Post approval and registry studies. Advantages and limitations in complementing trial evidence base and improving therapy adoption
Speaker: Ileana PIÑA, New York, USA
Discussant: Roxana MEHRAN, New York, USA
Comparative effectiveness studies. How they may help decision makers and support utilization in clinical practice?
Speaker: Rita REDBERG, San Francisco, USA
Discussant: Kenneth STEIN, Boston Scientific, USA]]></string></description>
<keyword><string language="fre"><![CDATA[Maladies cardiovasculaires]]></string></keyword>
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NOTE:Ileana PIÑA, New York, USA&lt;br&gt;Professor of Medicine &amp; Professor of Epidemiology/ Biostatistics. Case Western Reserve University. Graduated Quality Scholar. Louis Stokes Administration of Veteran’s Affairs. Dr. Piña, a cardiologist and heart failure/transplant expert received her MD at the University of Miami in 1976. She continued her education and received her Masters of Public Health in 2009 after completing a 3 year Fellowship in Quality at the Cleveland VA. She has served as Director of the Exercise Laboratory at the University of Miami, of Heart Failure and Cardiac Rehabilitation at Hahnemann University, of Cardiomyopathy at Temple University and Heart Failure/ Transplantation at University Hospitals Health System at Case Medical Center. Dr. Piña is the Principal Investigator of as well as has participated in many studies focused on improving heart failure and rehabilitation. She serves as an advisor/consultant to the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health and the Division of Epidemiology which allows her to assist in evaluation and review cardiovascular medical devices, epidemiologic research studies while working with the FDA staff. Dr. Piña is internationally recognized for her research in rehabilitation and recovery of heart failure patients. She has over 70 publications and is a world-renown speaker on this subject. She has been a recurrent presenter/speaker in the World Congress of Cardiology in Spain, Argentina, Berlin, and Beijing. She is also a National Spokesperson for Go Red for Women and the Heart Truth of Ohio in which she is dedicated to finding out why and coming up with solutions for women who suffer from Heart Disease, which will enable them to live healthier, longer, lives. In 1995, Dr. Piña established and initiated The National Heart Failure Training Program (N-Heft™) at Case Western Reserve University with Hector Ventura of Ochsner Medical Center in New Orleans, Louisiana which is a program that seeks to educate physicians and other healthcare professionals in best practices for treating heart failure. Dr. Piña is a recipient of many Outstanding Service Awards and Best Doctors recognition Awards 2010. She sits on numerous committees and chairs countless scientific sessions and meetings and is currently a member for the AHA (American Heart Association) Writing Group Women’s Cardiovascular Diseases Prevention Guidelines. She also representes the AHA at the Electronic Health Inititaive (eHI) and AHRQ Task Force on Workplace. 
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