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All About Clinical Trials - October 2016

London - UK 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 October 2016 Course and Workshop held in conjunction with EuroThrombosis Meeting, London, UK.

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

Course directors

Sven Wassmann, MD, PhD, FESC

Giuseppe MC Rosano, MD, PhD, FESC

Programme

Day 1 (Sessions and GCP course)

Session 1. How to design a clinical trial

An overview of the different aspects of clinical trials - Niessner

Traditional versus novel trial designing - G.M.C. Rosano

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

Session 2. Regulary aspects

Requirements from regulatory agencies: endpoints, comparators, type of studies - G.M.C. Rosanor

Post marketing surveillance - Walther

Session 3. How to run a trial efficiency

The role of the principal investigator: keys to success, perils and tribulations - B.S. Lewis

Session 4. Trials categories

Randomised controlled trials - Niessner

Observational trials and registries - G.L. Savarese

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)

How to interpret clinical trial data

Examples from recent clinical trials - Wassmann, Panelists

Perspectives of an Editor-in'Chief - S. Agewall

Certificates and closing remarks - B.S. Lewis, S. Wassmann