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All About Clinical Trials - December 2017 Vienna

Vienna - Austria Training Course and Workshop of the ESC Working Group on Cardiovascular Pharmacotherapy

The European Society of Cardiology 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 Amgen, Daiichi Sankyo & Pfizer.

Programme

Day 1 (Sessions and GCP course)

Welcome, introduction and course objectives - S. Wassmann

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 - D. Baltic

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

Randomised controlled trials - A. Niessner

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

Session 6: How to interpret Clinical Trials data

Reading between the lines:

How to interpret clinical trial data – Examples from recent clinical trials - S. Wassmann

Session 7: Good clinical practice

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

Day 2 Interactive workshops

Welcome and objectives - T. Walther

Issues in Clinical Trials

Diabetes trials: challenges and current directions - T. Schmidt

Workshop: Statistical issues in Clinical Trial - Basic notionss NOT RECORDED

Parallel groups:

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

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

 

Workshop: things to know for junior investigators NOT RECORDED

Parallel groups

  • How to write a manuscript - T. Schmidt
  • What you need to know as junior investigator - C. Ceconi
Closing remarks - C. Ceconi