All About Clinical Trials - March 2018

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

The ESC Working Group on Cardiovascular Pharmacotherapy is proud to be delivering an engaging and interactive 2-day course to improve the professional knowledge and skills required to plan and deliver successful cardiovascular pharmacotherapy clinical trials.

Our goal is for all participants to leave the meeting with the improved competence and confidence to deliver better clinical trials which in turn will have a positive impact on services and patient outcomes.

This course is aimed at improving knowledge and skills related to clinical trial planning and design as well as the successful running of different types of clinical trials. We will offer interactive sessions coordinated by top experts in their fields. In addition, the course will offer highly interactive workshops on Good Clinical Practice (GCP certificate included), statistics, trial data interpretation and manuscript writing.

At the end of the course delegates will have improved their knowledge in:

designing and planning successful clinical trials,
evaluating and following the correct processes and regulatory procedures,
effectively analysing and interpreting trial data.

This course will be an excellent opportunity for education, networking and creating opportunities.

Course directors

Sven Wassmann, MD, PhD, FESC

Giuseppe MC Rosano, MD, PhD, FESC

This programme is organised by the ESC Working Group on Cardiovascular Pharmacotherapy and supported by an educational grant from Novo Nordisk & Pfizer.

Programme

Day 1 (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

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

Planning and running a clinical trial: sponsors, CROs, adjudication and retention - B.S. Lewis

Traditional versus novel trial designing - J. Tamargo

Session 2. Regulary aspects

Requirements from regulatory agencies: endpoints, comparators, type of studies - C. Ceconi

Post marketing surveillance - T. Walther

Session 3. Clinical Trials - The sponsor's viewpoint

The sponsor´s viewpoint - J. Van der Veken

Session 4. What's next - Upcoming and ongoing Clinical Trials

ACS / Antithrombotics - S. Wassmann

Lipidology - B.S. Lewis

Diabetes - H. Drexel

Heart failure - C. Ceconi

Session 5. Trials categories

Observational trials and registries - G.L. Savarese

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Randomised controlled trials - A. Niessner

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

Session 6: Good clinical practice

GCP for the busy investigator (Not recorded)

Day 2 (Interactive workshops)

Issues in Clinical Trials

Novel antidiabetes drugs with cardiovascular benefit - T. Schmidt

Workshop: Statistical issues in Clinical Trial - Basic notions

Parallel groups (not recorded)

Randomised controlled trials and subgroup analyses - A. Niessner
Registries and meta-analyses – G. Savarese

Workshop how to interpret clinical trial data

Examples from recent clinical trials - S. Wassmann, Panelists

Interpreting meta-analyses and clinical trials: can we believe the data? G. Savarese

Workshop: things to know for junior investigators