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<title><string language="fre"><![CDATA[Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Non-inferiority, superiority, or both? Operationalizing the FDA guidance (debates).]]></string></title>
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<string language="fre"><![CDATA[Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : &lt;br&gt;Non-inferiority, superiority, or both? Operationalizing the FDA guidance (debates).
Speaker: Marc PFEFFER, Boston, USA
Discussant: Stuart POCOCK, London, GBR
Regulatory viewpoint: Kristina DUNDER, EMEA, SWE
Abstract : Non-inferiority, superiority, or both? Operationalizing the FDA guidance (debates).
L’auteur n’a pas transmis de conflit d’intérêt concernant les données diffusées dans cette vidéo ou publiées dans la référence citée.
Conférence enregistrée : 9th Global Cardiovascular Clinical Trialists Forum • Paris 2012 
Diabetes clinical trials : helped or hindered by the current shift in regulatory requirements? Glycaemic control is an inadequate surrogate marker of cardiovascular event reduction in patients with type 2 diabetes. Clinical trials to date have been unsuccessful in identifying a therapeutic approach that addresses the underlying problem in diabetes (glycaemic control) and reduces cardiovascular risk. The potential for some agents to increase the risk of cardiovascular events has led to substantial changes in regulatory requirements for new anti-diabetic therapies. These requirements, while key to ensuring the cardiovascular safety of new agents, fail to emphasize the need to show clinical benefits, such as less visual impairment, less need for dialysis, or fewer cardiovascular events and deaths. Changes in test results such as glycaemic control, serum creatinine, micro-albuminuria, or retinopathy are inadequate surrogates. Regulators should consider the potential advantages of offering extended patent protection in order to encourage companies to conduct long-term trials in diabetes and many other chronic medical conditions. Cooperative efforts among physicians, clinical trialists, regulators, and sponsors are needed to address unresolved issues including re-defining therapeutic targets that are meaningful to patients with diabetes, determining the appropriate length of follow-up for future trials, and considering the ethical and operational challenges of non-inferiority designs.
Chairpersons: Marc PFEFFER, Boston, USA - Kausik RAY, London, GBR
Réalisation, production : Canal U/3S et CERIMES
Keyword : Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, Baro-stimulation, diabetes]]></string></description>
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NOTE:POCOCK Stuart, London, GBR&lt;br&gt;Stuart Pocock is Professor of Medical Statistics at the London School of Hygiene and Tropical Medicine. His primary research interest concerns clinical trials, both as regards methodological developments and applied collaboration in major trials. His particular methodologic interests include: standards for the statistical reporting of trials and epidemiological studies, the statistical ethical and organisational principles for data monitoring including early stopping guidelines, the presentation of time-to-event (survival) data, the pros and cons of equivalence trials, and problems of multiplicity in trial reporting eg subgroup analyses, multiple outcomes and covariate adjustment. Professor Pocock runs a statistical centre for the design, conduct, analysis and reporting of major clinical trials, especially in cardiovascular diseases. He is also a consultant statistician for a wider range of clinical trials in which expert statistical advice is needed, and serves as a statistical member of many trial data monitoring and steering committees. He collaborates internationally especially with the Cardiovascular Research Foundation in New York and the New England Research Institutes in Boston. He is a frequent lecturer on a variety of clinical trial issues. 
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<date><dateTime>2012-12-01</dateTime></date>
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