13th CardioVascular Clinical Trialists (CVCT) WORKSHOP
Paris, December 5th and 6th, 2010

DAY ONE - Sunday December 5th, 2010
   
 
   
8:00-8:15 Welcome and introduction: Faiez ZANNAD
   
8:15-10:00 Chairman: Faiez ZANNAD
  • Session 1 - Running with scissors: when can we trust subgroup analysis
Speaker: Stuart POCOCK[ Présentation ]
Discussant: Nancy GELLER[ Présentation ]
Discussant Regulatory: Armin KOCH
   
10:00-10:30 Coffee Break
   
10:30-11:30 Chairman: Aldo MAGGIONI
  • Session 2 - Trial design for antiarrhythmic agents.
    Need for outcome studies. EMEA new notes of guidance
Speaker Regulatory: Gonzalo CALVO replaced by Angeles ALONSO
Discussant Regulatory: Norman STOCKBRIDGE - Ileana L. PIÑA[ Présentation ]
  Chairman: David GORDON
  • Session 3 - Timing of events in composite endpoints.
    Repeated measures for continuous data.
    Making the most of repeated events outcomes
Speaker: Janet WITTES[ Présentation ]
Discussants: Hans WEDEL - Chris O’CONNOR
Discussant Regulatory: Aldo MAGGIONI
13:00-14:00 Lunch Break
14:00-15:30 Chairman: Bertram PITT
  • Session 4 - Non scientific influence on trial conduct:
    Politicians/ Litigations / analysts /media/ activists
Speaker: Chris O’CONNOR
Discussants: Maarten SIMOONS - Marc PFEFFER[ Présentation ]
13:00-14:00 Lunch Break
16:00-17:30 Chairman: Jeffrey BORER
  • Session 5 - Comparative effectiveness, Comparative cost effectiveness (AHRQ)
Speaker: David GORDON[ Présentation ]
Discussant: Robert CODY
DAY TWO - Monday, December 6th, 2010
   
 
   
8:30-10:00 Chairman: Roxana MEHRAN
  • Session 6 - Device and interventional cardiology trials:
        Are there specific design, endpoint and interpretation issues?
Speaker: Roxana MEHRAN[ Présentation ]
Discussant Industry: Rita PEETERS
   
10:00-10:30 Coffee Break
   
10:30-11:30 Chairman: Luigi TAVAZZI
  • Session 7 - Criteria for trial validation of telemedicine devices
    for heart failure patients?
Speaker: Faiez ZANNAD[ Présentation ]
Discussant Industry: Katrin LEADLEY[ Présentation ]
11:30-12:30 Chairman: Marc PFEFFER
  • How can we learn to back winners?
    Why are so many trials neutral/ negative? Case-studies of “failures”
Speaker: Jeffrey BORER
Discussant: David GORDON[ Présentation ]
12:30-13:30 Lunch Break
 
13:30-15:00 Chairman: Gunnar OLSSON
  • Why are clinical trials so complicated and expensive?
    How can they be made less so?
Speaker: Christian TORP-PEDERSEN[ Présentation ]
Discussant: Alice MASCETTE
15:00-15:30 Coffee Break
 
15:30-17:00 Chairman: Janet WITTES
  • Session 8 - Design of trials of personalized medicine.
    Use of genetics/biomarkers for guiding/individualizing CV therapy
Speaker: Jan STAESSEN[ Présentation ]
Discussant: Yves ROSENBERG[ Présentation ]