Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Study drug and background therapy (debates).
- document 1 document 2 document 3
- niveau 1 niveau 2 niveau 3
- audio 1 audio 2 audio 3
Descriptif
Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : <br>Study drug and background therapy (debates).Speaker: Denise BONDS, NHLBI, USASpeaker: Michel MARRE, Paris, FRAAbstract : Study drug and background therapy (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, GBRRéalisation, production : Canal U/3S et CERIMESKeyword : Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, Baro-stimulation, diabetes
Thème
Notice
Documentation
Liens
Dans la même collection
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 5 : The Vaptans story …
MODIGLIANI Debate Session 5 - Saturday December 1st, 2012 NOVEL DIURETIC STRATEGIES IN HEART FAILURE Chairpersons: Keld KJELDSEN, Copenhagen, DEN - Gian Paolo ROSSI, Padua, ITA Webcast: Patrick
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 5 : Will we be able to answe…StroesEric
MODIGLIANI Workshop 5 - Saturday December 1st, 2012 THE ATHEROSCLEROSIS TRIALISTS FORUM Chairpersons: Wolfgang KOENIG, Ulm, GER - Anthony WIERZBICKI, London, GBR Webcast: Tabassome SIMON, Paris, FRA
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 5 : The Vaptans story …AbrahamWilliam T.
MODIGLIANI Debate Session 5 - Saturday December 1st, 2012 NOVEL DIURETIC STRATEGIES IN HEART FAILURE Chairpersons: Keld KJELDSEN, Copenhagen, DEN - Gian Paolo ROSSI, Padua, ITA Webcast: Patrick
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 5 : Ultrafiltration fo…
MODIGLIANI Debate Session 5 - Saturday December 1st, 2012 NOVEL DIURETIC STRATEGIES IN HEART FAILURE Chairpersons: Keld KJELDSEN, Copenhagen, DEN - Gian Paolo ROSSI, Padua, ITA Webcast: Patrick
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 5 : Insights from DOSE…MascetteAlice
MODIGLIANI Debate Session 5 - Saturday December 1st, 2012 NOVEL DIURETIC STRATEGIES IN HEART FAILURE Chairpersons: Keld KJELDSEN, Copenhagen, DEN - Gian Paolo ROSSI, Padua, ITA Webcast: Patrick
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 4 : What endpoint for …PinaIleanaFarbAndrew
MODIGLIANI Debate Session 4 - Saturday December 1st, 2012: HEART FAILURE REMOTE MONITORING TRIALS Chairpersons: Stefan ANKER, Berlin, GER - Ileana PIÑA, New York, USA Webcast: Daniela DOBRE, Nancy,
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 4 : Treatment optimiza…AbrahamWilliam T.
MODIGLIANI Debate Session 4 - Saturday December 1st, 2012: HEART FAILURE REMOTE MONITORING TRIALS Chairpersons: Stefan ANKER, Berlin, GER - Ileana PIÑA, New York, USA Webcast: Daniela DOBRE, Nancy,
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 5 : Will we be able to answe…RosensonRobert
MODIGLIANI Workshop 5 - Saturday December 1st, 2012 THE ATHEROSCLEROSIS TRIALISTS FORUM Chairpersons: Wolfgang KOENIG, Ulm, GER - Anthony WIERZBICKI, London, GBR Webcast: Tabassome SIMON, Paris, FRA
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 5 : Identifying new targets:…KoenigWolfgang
MODIGLIANI Workshop 5 - Saturday December 1st, 2012 THE ATHEROSCLEROSIS TRIALISTS FORUM Chairpersons: Wolfgang KOENIG, Ulm, GER - Anthony WIERZBICKI, London, GBR Webcast: Tabassome SIMON, Paris, FRA
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : Regulatory viewpoin…AndoYuki
MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012: HEART FAILURE TRIALISTS WORKSHOP LEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALS Chairpersons: Alexandre
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : The value of repeat…PocockStuart J.
MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012: HEART FAILURE TRIALISTS WORKSHOP LEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALS Chairpersons: Alexandre
-
Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : RELAX-HF (Michael F…
MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012: HEART FAILURE TRIALISTS WORKSHOP LEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALS Chairpersons: Alexandre
Avec les mêmes intervenants
-
Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Study drug and background therapy : o…MarreMichel
Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Study drug and background therapy : on top of or vs. Metformin? The issue of background therapy and comparator Speaker: Michel
-
Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Study drug and background therapy : I…MarreMichel
Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Study drug and background therapy : Insulin in type 2 diabetes: bad guy or good guy? Speaker: Michel MARRE, Paris, FRA Abstract :