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Nombre de programmes trouvés : 2173
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Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : How to secure the optimal dose(s) for phase III? (Nancy GELLER)

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

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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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Label UNT Conférences

le (12m26s)

Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Non-inferiority, superiority, or both? Operationalizing the FDA guidance

Title :Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Non-inferiority, superiority, or both? Operationalizing the FDA guidanceSpeaker: Marc PFEFFER, Boston, USADiscussant: Stuart POCOCK, London, GBRRegulatory viewpoint: Kristina DUNDER, EMEA, SWEAbstract : The evaluation of cardiovascular safety of rosiglitazone (2006-2010) had implications on regulatory guidance for glucose lowering drugs both in the EU and in the US and both the FDA and the CHMP guidelines for development of glucose lowering drugs have been updated including new requirements for assessment of cardiovascular safety. While the FDA Guidance is very precise specifying that the upper bound of the 95% confidence interval for the ...
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