Ressource pédagogique : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 2 : PET-CT imaging in clinical trials (James RUDD)

Informations pratiques sur cette ressource

Description de la ressource pédagogique

Description (résumé)

MODIGLIANI Workshop 2 - Friday November 30, 2012 : ATHEROSCLEROSIS IMAGING IN CLINICAL TRIALS Facilitating the discovery of effective therapies Chairpersons: Jagat NARULA, New York, USA - Ahmed TAWAKOL, Boston, USA Webcast: Bart STAELS, Lille, FRA Phase 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 called for the adoption of new biomarkers or surrogate endpoints to enhance the rate of clinical development. To that end, several cardiovascular imaging technologies have gone through evolutionary cycles of validation over the past decade and several have demonstrated promise as clinical tools and as clinical trial biomarkers. With the rapid development and implementation of these imaging approaches, it is important to delineate the opportunities and limitations associated with these tools. In particular, it is essential to identify imaging biomarkers that might accurately predict eventual clinical success based on the observed changes in the atherosclerotic imaging measurements. With such tools as gatekeepers, only those treatments with proven efficacy during Phase II trials would be promoted to Phase III with the expectation of high likelihood of success in the clinical endpoint trials. By enhancing the success rate of Phase III clinical trials, use of these imaging tools have the potential to accelerate the discovery of treatments for atherosclerosis. Session program: Overview: Why are imaging endpoints needed in CV clinical trials Speaker: Jagat NARULA, New York, USA Well Established Methods for Imaging Approaches: IVUS and IMT Speaker: Jean-Claude TARDIF, Montréal, CAN Discussant: Wolfgang KOENIG, Ulm, GER Coronary CTA in clinical trials Speaker: Udo HOFFMANN, Boston, USA MRI imaging in clinical trials Speaker: Zahi FAYAD, New York, USA Discussant: Robin CHOUDHURY, Oxford, GBR PET-CT imaging in clinical trials Speaker: Ahmed TAWAKOL, Boston, USA Discussant: James RUDD, Cambridge, GBR

"Domaine(s)" et indice(s) Dewey

• Maladies de l'appareil cardio-vasculaire (616.1)

Thème(s)