All About Clinical Trials - May 2017

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 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 - B.S. Lewis

Planning and running a clinical trial: sponsors, CROs, adjudication and retention – C. Tomino

Session 2. Regulary aspects

Requirements from regulatory agencies: endpoints, comparators, type of studies - G. Rosano

Post marketing surveillance - C. Ceconi

Session 3. Clinical Trials - The Industry Perspective

 The Industry perspective – C. Thostensen

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: What's next - upcoming and ongoing Clinical Trials

ACS/Antithropbotic Trials - B.S. Lewis

Lipidology - B.S. Lewis

Diabetes - H. Drexel

Heart Failure - G. Rosano

Session 6. Good clinical practice

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

Day 2 Interactive workshops

NOT AVAILABLE IN WEBCAST!

Attend next course

Workshop: Statistical issues in clinical trials - basic notions

Parallel groups (switch after 60 min):

• Randomised controlled trials and subgroup analyses
• Registries and meta-analyses

Workshop: How to interpret clinical trials data

Examples from recent clinical trials

Workshop: things to know for junior investigators

Parallel groups

• How to write a manuscript
• What you need to know as junior investigator

Closing remarks