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


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POCOCK Stuart

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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 guidance
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
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

 

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