Canal-U

Mon compte
Canal-U/Médecine

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


Copier le code pour partager la vidéo :
<div style="position:relative;padding-bottom:56.25%;padding-top:10px;height:0;overflow:hidden;"><iframe src="https://www.canal-u.tv/video/canal_u_medecine/embed.1/cardiovascular_clinical_trialists_cvct_forum_paris_2012_workshop_1_how_to_secure_the_optimal_dose_s_for_phase_iii_nancy_geller.11450?width=100%&amp;height=100%" style="position:absolute;top:0;left:0;width:100%;height: 100%;" width="550" height="306" frameborder="0" allowfullscreen scrolling="no"></iframe></div> Si vous souhaitez partager une séquence, indiquez le début de celle-ci , et copiez le code : h m s
Auteur(s) :
GELLER Nancy

Producteur Canal-U :
Canal-U/Médecine
Contacter le contributeur
J’aime
Imprimer
partager facebook twitter Google +

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 WORKSHOP
DOSE AND TARGET PATIENT POPULATIONS ISSUES

Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN, Bucharest, ROM
Webcast: Johanne SILVAIN, Paris, FRA

The 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 are limited by small numbers of events and short follow-up. Some recent phase III trials have produced results that were unanticipated from the phase II findings.
➢ Adaptive designs to explore safety (bleeding) risks have been proposed to overcome the current limitations of dose selection for phase III. Several concerns with these designs remain unresolved, such as appropriate methods to control Type I error for both safety and efficacy. Also, adaptive designs will only be useful if they are accepted by the regulatory agencies. The agencies have not announced a final position yet. Implementation of adaptive designs requires early and in-depth interaction between the agencies and study sponsors.
➢ With the newer anti-thrombotic agents progressively potentially replacing warfarin, we are moving from a target INR guided dosing to an indication/risk guided dosing. Different doses are being developed for different indications. There is an intense discussion on whether doses of anticoagulants should be similar or different for preventing DVT after orthopedic surgery, for treating DVT and pulmonary embolism, for AFib, for prevention after ACS and for prevention in artificial valves. Dose - effect relationships are difficult to establish. A balance should be found between the dose relationship with clinical benefit and the dose relationship with the risk of bleeding. An intense discussion is also ongoing on whether a range of doses rather than one single dose should be made available for the same disease.
➢ Exploring new indications for the newer anti-thrombotic agents might be one target of interest in patients with heart failure. In patients with coronary artery disease and HF, a majority of deaths (including sudden death) appear to be related to ischemia and worsening of heart failure. The presence of pulmonary embolism as a cause of worsening HF is underestimated and certain underlying pathophysiological mechanisms are common to both arterial and venous thrombi. It has been recognized since long that HF is associated with hypercoagulable state, and, at the cellular level, it has been reported that thrombin exerts multiple actions on cardiomyocytes which can favor the genesis of arrhythmias and myocyte injury. Antithrombotic strategies to reduce the risk of death, myocardial infarction (MI), or stroke have been tested in several randomized trials. These studies were underpowered and the recently published WARCEF trial is inconclusive. With the newest
ant-thrombotic agents being probably safer, heart failure might be one of the next diseases where to expand the indications of new antithrombotics. Designing an anti-thrombotic trial in HF might also yield meaningful data regarding the potential role of thrombosis in patients with heart failure.

The aim of this session is to explore novel, scientifically rigorous methodologies through an open, cooperative dialogue among investigators, regulators, and sponsors.

Session program:
Dosing issues
• How to secure the optimal dose(s) for phase III? Can adaptive design help?
Speaker: Nancy GELLER, NHLBI, USA
Discussant: Michael GIBSON, Boston, USA
• Different doses, different indications? DVT and pulmonary embolism, Atrial fibrillation, ACS, artificial valves
Speaker: Freek VERHEUGT, Amsterdam, NED
Discussant ACS: Maarten SIMOONS, Rotterdam, NED
Industry viewpoint: Scott BERKOWITZ, Bayer, USA - Christophe GAUDIN, Sanofi, FRA - Lloyd HASKEL, J&J, USA - Yasser KHDER, Boehringer Ingelheim, FRA - Joerg KOGLIN, Merck, USA - John LAWRENCE, BMS, USA
Regulatory viewpoint: Angeles ALONSO, EMEA, ESP - Pieter DE GRAEF, EMEA, NED - Kaori SHINAGAWA, PMDA, JAP
New indications: Is heart failure a viable new potential indication for anti-thrombosis therapy
Speaker: Faiez ZANNAD, Nancy, FRA
Discussants: Efthymios DELIARGYRIS, MedCo, USA - Lloyd HASKEL, J&J, USA
Regulatory viewpoint: Krishna PRASAD, MHRA, GBR

  •  
  •  
    Date de réalisation : 30 Novembre 2012
    Durée du programme : 13 min
    Classification Dewey : Maladies de l'appareil cardio-vasculaire
  •  
    Catégorie : Conférences
    Niveau : Spécialités de médecine, Formation continue
    Disciplines : Santé publique environnement et société, Cardiologie
    Collections : CVCT 9th Global Cardiovascular Clinical Trialists Forum • Paris 2012
    ficheLom : Voir la fiche LOM
  •  
    Auteur(s) : GELLER Nancy
    producteur : Canal U/3S - CERIMES
    Réalisateur(s) : Canal U/3S - CERIMES
  •  
    Langue : Anglais
    Mots-clés : Maladies cardiovasculaires
 

commentaires


Ajouter un commentaire Lire les commentaires
*Les champs suivis d’un astérisque sont obligatoires.
Aucun commentaire sur cette vidéo pour le moment (les commentaires font l’objet d’une modération)
 

Dans la même collection

 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : How to secure the optimal dose(s) for phase III? (Michael GIBSON)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : Different doses, different indications? (Freek VERHEUGT)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : New indications: Is heart failure a viable new potential indication for anti-thrombosis therapy (Efthymios DELIARGYRIS)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : New indications: Is heart failure a viable new potential indication for anti-thrombosis therapy (Faiez ZANNAD)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : New indications: Is heart failure a viable new potential indication for anti-thrombosis therapy (Krishna PRASAD)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : Industry viewpoint (Joerg KOGLIN)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Non randomized and/or non-blinded trials (Stuart POCOCK)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Industry perspective (Holger WOEHRLE)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Options of and alternatives to the “control group” in device trials (William T. ABRAHAM)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 2 : Well Established Methods for Imaging Approaches, IVUS and IMT (Wolfgang KOENIG)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 5 : Will we be able to answer the question of HDL as a therapeutic target after the CETP inhibitor trials? (Eric STROES)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 5 : Insights from DOSE and gaps in evidence with diuretic therapy (Alice MASCETTE)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 5 : Ultrafiltration for acute cardiorenal syndrome in heart failure (Gian Paolo ROSSI)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 5 : The Vaptans story post-EVEREST (William T. ABRAHAM)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 5 : The Vaptans story post-EVEREST (Michael FELKER)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 5 : Will we be able to answer the question of HDL as a therapeutic target after the CETP inhibitor trials? (Robert ROSENSON)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 4 : Treatment optimization (William T. ABRAHAM)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 4 : What endpoint for securing approval and reimbursement (Andrew FARB - Ileana PIÑA)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : The value of repeat events in post discharge hospitalized HF trials (Stuart POCOCK)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : Regulatory viewpoint (Yuki ANDO)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 5 : Identifying new targets: Monoclonal Antibody Inhibitor of PCSK9 (Wolfgang KOENIG)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : Endpoint related issues (Alexandre MEBAZAA)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : PRONTO (Frank PEACOCK)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : Execution issues (Mihai GHEORGHIADE)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : ASTRONAUT (Aldo MAGGIONI)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : RELAX-HF (Michael FELKER)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 :Regulatory viewpoint (Pieter DE GRAEF)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 :How to secure the optimal dose(s) for phase III? How to secure the optimal dose(s) for phase III?
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 5 : Identifying new targets: The value of omics and mendelian randomization studies (Daniel SWERDLOW)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Approvability issues: Pathway to a more global device approval process (Ileana PIÑA)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Post approval and registry studies (Ileana PIÑA)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Comparative effectiveness studies (Kenneth STEIN)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Comparative effectiveness studies (Rita REDBERG)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Industry perspective (Rob KIEVAL)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Post approval and registry studies (Roxana MEHRAN)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : How much one could deviate from “randomized - controlled” trials? Questions
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : Regulatory viewpoint (Angeles ALONSO)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : Industry viewpoint (Christophe GAUDIN)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : Regulatory viewpoint (Kaori SHINAGAWA)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : New indications: Is heart failure a viable new potential indication for anti-thrombosis therapy (Lloyd HASKEL)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : Different doses, different indications? (Maarten SIMOONS)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : Dosing Issues, Questions
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : Industry viewpoint (Yasser KHDER)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 2 : PET-CT imaging in clinical trials (James RUDD)
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : National guideline implementation and national registries.
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : National guideline implementation and national registries.
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Omics research and system biology. Keys for future personalized medicine How future trials may help optimizing benefit-to-risk ratio. The role of specialist scientific organizations.
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Omics research and system biology. Keys for future personalized medicine How future trials may help optimizing benefit-to-risk ratio. The role of specialist scientific organizations.
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : debate Omics research and system biology. Keys for future personalized medicine How future trials may help optimizing benefit-to-risk ratio. The role of specialist scientific organizations.
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : The role of biomarkers
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Journal editor’s viewpoints
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Journal editor’s viewpoints
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : How should diagnostic/prognostic markers be studied?
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : How should diagnostic/prognostic markers be studied?
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Best statistical methods for evaluating the merits of a novel marker
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Best statistical methods for evaluating the merits of a novel marker
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : debate : Best statistical methods for evaluating the merits of a novel marker (debates).
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Biomarker guided-therapy: Are there other endpoints besides mortality that matter? Selecting the best outcome measures
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable. Should there be a position statement establishing rules for biomarker studies?
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable. Should there be a position statement establishing rules for biomarker studies?
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Resistant hypertension trials: Can renal denervation therapy lower blood pressure?
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Resistant hypertension trials: Can renal denervation therapy lower blood pressure?
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Barostim: Experience so far and future developments
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Autonomic modulation therapy for heart failure: Preclinical data and ongoing trials
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for approval (FDA, and in EU, beyond CE mark) and reimbursement
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for approval (FDA, and in EU, beyond CE mark) and reimbursement
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for approval (FDA, and in EU, beyond CE mark) and reimbursement
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : conclusion
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : SHIfTing evidence in heart failure management.
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Save life and save cost with ivabradine.
 Cardiovascular Clinical Trialists (CVCT) Forum – Lipid lowering agents. Now, we have an option! (SHARP, 4D, AURORA)
 Cardiovascular Clinical Trialists (CVCT) Forum – EVOLVE: A major cardiovascular outcomes trial in hemodialysis patients.
 Cardiovascular Clinical Trialists (CVCT) Forum – EVOLVE: A major cardiovascular outcomes trial in hemodialysis patients
 Cardiovascular Clinical Trialists (CVCT) Forum – EVOLVE: A major cardiovascular outcomes trial in hemodialysis patients
 Cardiovascular Clinical Trialists (CVCT) Forum – EVOLVE: A major cardiovascular outcomes trial in hemodialysis patients (debates).
 Cardiovascular Clinical Trialists (CVCT) Forum – RAAS inhibitors and Mineralocorticoid receptor antagonists (FOSIDIAL, ALCHEMIST)
 Cardiovascular Clinical Trialists (CVCT) Forum – Interpretation and approvability issues.
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Impact of major clinical trials on ESC Chronic Heart Failure 2012 guidelines. Game changer trials: EMPHASIS-HF, SHIFT, Devices…
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Expected implications on heart failure epidemiology.
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Compound vs. class effect. Drug class recommendations in guidelinesCanadian, Australian CHF guideline and 2010 NICE guideline.
 Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Is it always safe to believe in class effect: Spironolactone vs. eplerenone differences and clinical relevance?
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Globalization of Diabetes trials: Epidemiology of diabetes in the Middle East and Asian countries
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Globalization of Diabetes trials: Epidemiology of diabetes in the Middle East and Asian countries
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Globalization of Diabetes trials: Epidemiology of diabetes in the Middle East and Asian countries (debates).
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Target populations: How do we risk-stratify? Are additional biomarkers helpful?
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Target populations: How do we risk-stratify? Are additional biomarkers helpful?
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Target populations: How do we risk-stratify? Are additional biomarkers helpful? (debates)
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Study drug and background therapy : Insulin in type 2 diabetes: bad guy or good guy?
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : What else than glucose control? Lipids, BP, Weight, Kidney
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Study drug and background therapy (debates).
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Non-inferiority, superiority, or both? Operationalizing the FDA guidance
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Non-inferiority, superiority, or both? Operationalizing the FDA guidance
 Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Non-inferiority, superiority, or both? Operationalizing the FDA guidance (debates).
 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
FMSH
 
Facebook Twitter Google+
Mon Compte