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Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Non randomized and/or non-blinded trials (Stuart POCOCK)
MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012THE DEVICE THERAPY TRIALISTS WORKSHOPChairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USAWebcast: Tariq AHMAD, Durham, USADevice trial methodology, regulatory and implementation issuesAdvances 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 ... Voir la vidéole (8m53s)
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Industry perspective (Rob KIEVAL)
MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012THE DEVICE THERAPY TRIALISTS WORKSHOPChairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USAWebcast: Tariq AHMAD, Durham, USADevice trial methodology, regulatory and implementation issuesAdvances 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 ... Voir la vidéole (12m26s)
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Post approval and registry studies (Roxana MEHRAN)
MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012THE DEVICE THERAPY TRIALISTS WORKSHOPChairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USAWebcast: Tariq AHMAD, Durham, USADevice trial methodology, regulatory and implementation issuesAdvances 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 ... Voir la vidéole (21m53s)
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Comparative effectiveness studies (Kenneth STEIN)
MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012THE DEVICE THERAPY TRIALISTS WORKSHOPChairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USAWebcast: Tariq AHMAD, Durham, USADevice trial methodology, regulatory and implementation issuesAdvances 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 ... Voir la vidéole (15m3s)
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 2 : Well Established Methods for Imaging Approaches, IVUS and IMT (Wolfgang KOENIG)
MODIGLIANI Workshop 2 - Friday November 30, 2012 :ATHEROSCLEROSIS IMAGING IN CLINICAL TRIALSFacilitating the discovery of effective therapiesChairpersons: Jagat NARULA, New York, USA - Ahmed TAWAKOL, Boston, USAWebcast: Bart STAELS, Lille, FRAPhase III clinical endpoint trials evaluating treatments for atherosclerosis typically require very large sample sizes, cost hundreds of millions of dollars and historically have had very low success rates. As a result, few new therapies that attenuate the progression of atherosclerosis have been identified in over 30 years (since the discovery of statins). Nearly a decade ago, in recognition of the low success of Phase III trials, regulatory agencies ... Voir la vidéole (24m8s)
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : RELAX-HF (Michael FELKER)
MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012:HEART FAILURE TRIALISTS WORKSHOPLEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALSChairpersons: Alexandre MEBAZAA, Paris, FRA - Christopher O’CONNOR, Durham, USAWebcast: Daniela DOBRE, Nancy, FRADecreasing the very high mortality and rate of re-hospitalization associated with acute worsening HF is one of the most important unmet needs in cardiovascular medicine. Despite positive signals in Phase II studies, no drug has proven to reduce the appallingly high mortality or readmission rates. The reasons for these ‘failed’ trials are multiple, including the adequacy of candidate drugs, dosing, patient selection and disease ... Voir la vidéole (21m54s)
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : Execution issues (Mihai GHEORGHIADE)
MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012:HEART FAILURE TRIALISTS WORKSHOPLEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALSChairpersons: Alexandre MEBAZAA, Paris, FRA - Christopher O’CONNOR, Durham, USAWebcast: Daniela DOBRE, Nancy, FRADecreasing the very high mortality and rate of re-hospitalization associated with acute worsening HF is one of the most important unmet needs in cardiovascular medicine. Despite positive signals in Phase II studies, no drug has proven to reduce the appallingly high mortality or readmission rates. The reasons for these ‘failed’ trials are multiple, including the adequacy of candidate drugs, dosing, patient selection and disease ... Voir la vidéole (16m19s)
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : ASTRONAUT (Aldo MAGGIONI)
MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012:HEART FAILURE TRIALISTS WORKSHOPLEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALSChairpersons: Alexandre MEBAZAA, Paris, FRA - Christopher O’CONNOR, Durham, USAWebcast: Daniela DOBRE, Nancy, FRADecreasing the very high mortality and rate of re-hospitalization associated with acute worsening HF is one of the most important unmet needs in cardiovascular medicine. Despite positive signals in Phase II studies, no drug has proven to reduce the appallingly high mortality or readmission rates. The reasons for these ‘failed’ trials are multiple, including the adequacy of candidate drugs, dosing, patient selection and disease ... Voir la vidéole (1h34m0s)


