Course directors
Sven Wassmann, MD, PhD, FESC
Giuseppe MC Rosano, MD, PhD, FESC
Programme
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
NOT AVAILABLE IN WEBCAST!
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
NOT AVAILABLE IN WEBCAST!