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All About Clinical Trials - March 2017

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

The ESC Working Group on Cardiovascular Pharmacotherapy has developed 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 2017 Course and Workshop held at the European Heart Agency, Brussels, Belgium.

This programme is supported with an educational grant by Amgen, Daiichi Sankyo & Pfizer.

Course directors

Sven Wassmann, MD, PhD, FESC

Giuseppe MC Rosano, MD, PhD, FESC


Day 1 (Sessions and GCP course)

The ESC Working Group on Cardiovascular Pharmacotherapy: Perspectives of a Past-Chairman and Editor-in-Chief - S. Agewall
Session 1. How to design and run a clinical trial

An overview of the different aspects of clinical trials - A. Niessner

Traditional versus novel trial designing - J. Tamargo

Planning and running a clinical trial: the research site - players, facilities, ethics, logistics sponsors, CROs, adjudication and retention - B.S. Lewis

Session 2. Regulary aspects

Requirements from regulatory agencies: endpoints, comparators, type of studies - T. Schmidt

Post marketing surveillance - T. Walther

Session 3. Issues in Clinical Trials

Issues in clinical trials: Lipidology - challenges and current directions - H. Drexel

The team, the procedures, the monitor and the sponsor - B.S. Lewis

Session 4. Trials categories

Observational trials and registries - G.L. Savarese

Randomised controlled trials - Niessner

Meta-analyses and systematic reviews - G.L. Savarese

Session 5. Good clinical practice

GCP for the busy investigator (certificate included) - D. Rolfe

Day 2 (Workshops)

What's next – upcoming and ongoing Clinical Trials

ACS / Antithrombotics - B.S. Lewis

Lipidology - B.S. Lewis

Diabetes - T. Schmidt

Heart failure - T. Schmidt

Workshop: Statistical issues in clinical trials - Basic notions
  • Parallel groups (switch after 60 min):
  • Randomised controlled trials and subgroup analyses - A. Niessner
  • Registries and meta-analyses - G. Savarese


Attend next course

How to interpret clinical trial data

Examples from recent clinical trials - Wassmann, Panelist

Workshop: Things to know for junior investigators

Parallel groups:

  • How to write a manuscript - S. Wassmann
  • What you need to know as junior investigator


Attend next course