All About Clinical Trials - October 2015 - Barcelona - Spain

Course directors

Juan Tamargo, MD, PhD, FESC

Sven Wassmann, MD, PhD, FESC

Programme

Day 1

• 10:15: Welcome, introduction and course objectives - S. Wassmann, J. Tamargo

SESSION 1. HOW TO DESIGN A CLINICAL TRIAL

• 10:30: An overview of the different aspects of clinical trials - A. Niessner
  
• 11:00: Traditional versus novel trial designing - J. Tamargo
  
• 11:30: The objectives, the site, the finance and the role of the ethics committee and research organization - B.S. Lewis
  
• 12:00: Refreshments and networking

SESSION 2. REGULATORY ASPECTS

• 12:30: Requirements from regulatory agencies:  endpoints, comparators, type of studies - J.Tamargo
  
• 13:00: Post marketing surveillance - T. Walther
  
• 13:30: Lunch and networking

SESSION 3. HOW TO RUN A TRIAL EFFICIENTLY

• 14:30: The role of the principal investigator: keys to success, perils and tribulations - B.S. Lewis
  
• 15:00: The team, the procedures, the monitor and the sponsor - L. Parker
  
• 15:30: The role of the research office - M.C. MacLennan
  
• 16:00: Refreshments and networking

SESSION 4. TRIAL CATEGORIES

• 16:30: Randomised controlled trials and registries - A. Niessner
  
• 17:00: Observational trials and registries - G.L. Savarese
  
• 17:30: Meta-analyses and systematic reviews - G.L. Savarese
  
• 18:00: Close of day 1

Day 2 (Workshops)

• 08:15: Welcome and objectives - S. Wassmann, J. Tamargo
• 08:30: Good clinical practice - D. Rolfe
  
• 10:30: Refreshments and networking

• 11:00: Statistical issues in clinical trials – Basic notions
  • Randomised controlled trials – A. Niessner
    
  • Observational trials and registries – G.L. Savarese
    
  • Meta-analyses and systematic reviews – G.L. Savarese
    

• 12:30: Lunch and networking

• 13:30: How to interpret clinical trial data - Examples from recent clinical trials - S. Wassmann, Panelists
  • Selecting the appropriate journal
  • How to structure and format the manuscript, organise the data, prepare figures and tables, discuss the findings, write the conclusions and abstract
  • Characteristics of a good manuscript 
  • How to increase the chance of getting it accepted
  • 15:00: How to write a manuscript: how to make the most of your data - S. Wassmann, B.S. Lewis

Perspectives of an Editor-in-Chief

• 16:00: Certificates and closing remarks - S. Wassmann, J. Tamargo