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Nombre de programmes trouvés : 12223
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Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 2 : PET-CT imaging in clinical trials (James RUDD)

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 ...
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le (1h17m57s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Approvability issues: Pathway to a more global device approval process (Ileana PIÑA)

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 ...
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le (10m8s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Post approval and registry studies (Ileana PIÑA)

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 ...
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Conférences

le (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 ...
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Conférences

le (33m43s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Comparative effectiveness studies (Rita REDBERG)

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 ...
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Conférences

le (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 ...
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Conférences

le (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 ...
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Conférences

le (19m5s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : How much one could deviate from “randomized - controlled” trials? Questions

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 ...
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Conférences

le (36m30s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 :Regulatory viewpoint (Pieter DE GRAEF)

MODIGLIANI Workshop 1 - Friday November 30, 2012 :THE THROMBOSIS TRIALISTS WORKSHOPDOSE AND TARGET PATIENT POPULATIONS ISSUESChairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN, Bucharest, ROMWebcast: Johanne SILVAIN, Paris, FRAThe development of new antithrombotic agents is a challenging area of cardiovascular medicine.These agents generally have a narrow therapeutic margin, and it is often difficult to find the optimal balance between efficacy (reduction of ischemic events) and safety (no excess of bleeding events).➢ Phase II trials are designed to generate signals of safety and efficacy and to select the dose or doses for phase III pivotal trials. However, phase II data ...
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Conférences

le (23m46s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 :How to secure the optimal dose(s) for phase III? How to secure the optimal dose(s) for phase III?

MODIGLIANI Workshop 1 - Friday November 30, 2012 :THE THROMBOSIS TRIALISTS WORKSHOPDOSE AND TARGET PATIENT POPULATIONS ISSUESChairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN, Bucharest, ROMWebcast: Johanne SILVAIN, Paris, FRAThe development of new antithrombotic agents is a challenging area of cardiovascular medicine.These agents generally have a narrow therapeutic margin, and it is often difficult to find the optimal balance between efficacy (reduction of ischemic events) and safety (no excess of bleeding events).➢ Phase II trials are designed to generate signals of safety and efficacy and to select the dose or doses for phase III pivotal trials. However, phase II data ...
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