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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:Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAI, is Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine. Dr. Mehran completed her training in internal medicine at the University of Connecticut, where she was also a Chief Medical Resident, before continuing with Fellowships in Cardiovascular Disease and Interventional Cardiology at Mount Sinai Medical Center. Dr. Mehran is internationally recognized for her work as a clinical trial specialist with complex data analyses and outcomes research within the field of interventional cardiology and for her experience and expertise in working with regulatory agencies to conduct clinical trials. Her research interests expand from mechanisms of restenosis to treatment and prevention of acute kidney injury in cardiac patients, as well as advancing treatments for acute coronary syndromes and acute myocardial infarction. In addition to founding a highly regarded academic research organization&nbsp; (ARO) within the Cardiovascular Research Foundation, she is also a widely published author and frequent invited speaker at national and international scientific conferences such as American Heart Association, American College of Cardiology, European Society of Cardiology, and EuroPCR. She has served as Course Co-Director of the annual Transcatheter Cardiovascular Therapeutics (TCT) for the last 13 years. Dr. Mehran serves on editorial board of multiple peer&lt;br&gt;reviewed journals, including Journal of the American College of Cardiology, Circulation, and Circulation Research. She currently serves on the board of trustees of SCAI, as a member of the Program Committee for the American Heart Association Scientific Sessions, as a member of the board of directors for Harboring Hearts, and as Program Chair for Society of Cardiac Angiography and Interventions (SCAI- WIN (Women in Innovations)) Initiative, and is also the Chief Scientific Officer of the Clinical Trials Center at the Cardiovascular Research Foundation (NYC). 
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