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All About Clinical Trials - March 2016 - Brussels - Belgium

Training Course and Workshop of the ESC Working Group on Cardiovascular Pharmacotherapy

The ESC Working Group on Cardiovascular Pharmacotherapy has developped an engaging and interactive educational programme to improve the professional knowledge and skills required to plan and deliver successful cardiovascular pharmacotherapy clinical trials.

Please find below resources from March 2016 Course and Workshop held at the European Heart Agency, Brussels, Belgium. 

This programme is supported by an unrestricted educational grant from Daiichi Sankyo.



Course directors

Sven Wassmann, MD, PhD, FESC
Giuseppe MC Rosano, MD, PhD, FESC

Programme

Day 1: course

  • 08:55: Welcome, introduction and course objectives - S. Wassmann, G.M.C. Rosano
SESSION 1. HOW TO DESIGN A CLINICAL TRIAL
  • 09:00: An overview of the different aspects of clinical trials - A. Niessner



  • 09:30: Traditional versus novel trial designing - J. Tamargo



  • 10:00: The objectives, the site, the finance and the role of the ethics committee and research organization - B.S. Lewis



  • 10:30: Refreshments and networking
SESSION 2. REGULATORY ASPECTS 
  • 11:00: Requirements from regulatory agencies:  endpoints, comparators, type of studies - G.M.C. Rosano



  • 11:30: Post marketing surveillance - C. Ceconi



SESSION 3. HOW TO RUN A TRIAL EFFICIENTLY
  • 12:00: The role of the principal investigator: keys to success, perils and tribulations - H. Drexel



  • 12:30: The team, the procedures, the monitor and the sponsor - C. Torp-Pedersen



  • 13:00: Lunch and networking
SESSION 4. TRIAL CATEGORIES
  • 14:00: Randomised controlled trials - A. Niessner



  • 14:30: Observational trials and registries - G.L. Savarese



  • 15:00: Meta-analyses and systematic reviews - G.L. Savarese



  • 15:30: Refreshments and networking
SESSION 5. GOOD CLINICAL PRACTICE
  • 16:00: GCP for the busy investigator (certificate included)



  • 18:00: Close of day 1 

Day 2: workshops

  • 08:55: Welcome and objectives - S. Wassmann, G.M.C. Rosano
  • 09:00: Statistical issues in clinical trials – Basic notions - A. Niessner, G.L. Savarese
    • Randomised controlled trials



    • Observational trials and registries



    • Meta-analyses and systematic reviews



  • 10:30: Refreshment and networking
  • 11:00: How to interpret clinical trial data - Examples from recent clinical trials - S. Wassmann, Panelists



  • 12:30: How to write a manuscript - G.M.C. Rosano, S. Wassmann, S. Agewall
    • How to make the most of your data



    • Perspectives of an Editor-in-Chief



  • 13:00: Certificates and closing remarks
  • 13:15: Lunch and networking
  • 14:00: Close of day 2