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All About Clinical Trials - October 2015 - Barcelona - Spain

Training 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 October Clinical Trials Workshop held in Hotel Sants Barcelo, Barcelona, Spain.

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



Course directors

Juan Tamargo, MD, PhD, FESC

Sven Wassmann, MD, PhD, FESC

Programme

Day 1

  • 10:15: Welcome, introduction and course objectives - S. Wassmann, J. Tamargo
SESSION 1. HOW TO DESIGN A CLINICAL TRIAL
  • 10:30: An overview of the different aspects of clinical trials - A. Niessner
  • 11:00: Traditional versus novel trial designing - J. Tamargo
  • 11:30: The objectives, the site, the finance and the role of the ethics committee and research organization - B.S. Lewis
  • 12:00: Refreshments and networking
SESSION 2. REGULATORY ASPECTS
  • 12:30: Requirements from regulatory agencies:  endpoints, comparators, type of studies - J.Tamargo
  • 13:00: Post marketing surveillance - T. Walther
  • 13:30: Lunch and networking
SESSION 3. HOW TO RUN A TRIAL EFFICIENTLY
  • 14:30: The role of the principal investigator: keys to success, perils and tribulations - B.S. Lewis
  • 15:00: The team, the procedures, the monitor and the sponsor - L. Parker
  • 15:30: The role of the research office - M.C. MacLennan
  • 16:00: Refreshments and networking
SESSION 4. TRIAL CATEGORIES
  • 16:30: Randomised controlled trials and registries - A. Niessner
  • 17:00: Observational trials and registries - G.L. Savarese
  • 17:30: Meta-analyses and systematic reviews - G.L. Savarese
  • 18:00: Close of day 1

Day 2 (Workshops)

  • 08:15: Welcome and objectives - S. Wassmann, J. Tamargo
  • 08:30: Good clinical practice - D. Rolfe
  • 10:30: Refreshments and networking

 

  • 11:00: Statistical issues in clinical trials – Basic notions
    • Randomised controlled trials – A. Niessner
    • Observational trials and registries – G.L. Savarese
    • Meta-analyses and systematic reviews – G.L. Savarese
  • 12:30: Lunch and networking

 

  • 13:30: How to interpret clinical trial data - Examples from recent clinical trials - S. Wassmann, Panelists
    • Selecting the appropriate journal
    • How to structure and format the manuscript, organise the data, prepare figures and tables, discuss the findings, write the conclusions and abstract
    • Characteristics of a good manuscript 
    • How to increase the chance of getting it accepted
    • 15:00: How to write a manuscript: how to make the most of your data - S. Wassmann, B.S. Lewis

Perspectives of an Editor-in-Chief

  • 16:00: Certificates and closing remarks - S. Wassmann, J. Tamargo