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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: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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