12th CardioVascular Clinical Trialists (CVCT) WORKSHOP
Luxembourg, December 6th and 7th, 2009
DAY ONE - Sunday December 6th, 2009
   
8.20-12.50, Topic 1:
Development of new agents for the treatment of heart failure.
Chairmen: Robert Temple, Faiez Zannad
   
8.20–9.30
   
9.30–10.20
    Are trials with “add on therapy design” the only way to go?
  • Speaker: Bruno Flamion [presentation]
  • Discussant: Robert Cody
   
10.40–11.40
    The use of biomarkers in heart failure trials (for patient selection and/or surrogates)
  • Speaker: Norman Stockbridge [presentation]
  • Discussant 1 : Robert Morrow
  • Discussant 2 : Nancy Geller [presentation]
   
11.40–13.00
   
14.00–18.30, Topic 2:
Risk-benefit decisions for anti-thrombotic therapies: Clinical and Regulatory challenges.
Chairmen: Marteen Simoons, Norman Stockbridge
   
14.00–15.00
    Selecting the appropriate study design: Positive control vs. non inferiority comparative trials. Which way to go?
  • Speaker: Robert Temple [presentation]
  • Discussant: Stuart Pocock [presentation]
   
15.00–16.10
    Risk benefit issues in progressing to Phase III. .Do surrogates and/or adaptive design help?
  • Speaker: Norman Stockbridge [presentation]
  • Discussant 1: Sidney Goldstein [presentation]
  • Discussant 2: Hubert Pouleur
   
16.30–17.30
    Bleeding outcomes: Definition and adjudication issues.
  • Speaker: Marteen Simoons [presentation]
  • Discussant : Armin Koch
   
17.30–18.30
    Combining efficacy and safety in Composite endpoints.
  • Speaker: Lennart Forslund
  • Discussant: Janet Wittes [presentation]
DAY TWO - Monday December 7th, 2009
   
8.30 – 11.50, Topic 3:
Need for outcome studies in the development of anti-diabetic medicinal products.
Chairman: Jeffrey Borer
   
8.20–9.30
    Cardiovascular efficacy outcomes in diabetes trials
  • Speaker: Christian Torp Pedersen [presentation]
  • Discussant: Hans-Juergen Woerle [presentation]
   
9.30–10.30
   
10.50–11.50
   
12.00 – 13.00, Topic 4:
Current limitations of registration data package
Chairman: Pieter de Graeff
   
12.00–13.00
   
14.00 - 15.00, Topic 6:
Comparative effectiveness.
Pragmatic trials of alternative intervention strategies. (eg. SYNTAX, RITA 3, COURAGE…)
Chairman: Stuart Pocock
   
14.00–15.00
   
15.00–17.10, Topic 7:
Alternatives to Randomized Clinical Trials ?
Chairman : Bertram Pitt
   
15.00–15.40
   
16.00–16.40
   
16.40
    Wrap up and adjourn
  • Faiez Zannad