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
Our mission: To reduce the burden of cardiovascular disease.