ESPGHAN Masterclass on Clinical Trials in Paediatric Gastroenterology, Hepatology & Nutrition

Application Deadline: 21.12.2016

Registration Fee

ESPGHAN Master Class Clinical Trials For Members Involved In Planing And Conducting Clinical Trials In Paediatric Gastroenterology, Hepatology and Nutrition

Local Organiser:
Mary Fewtrell        
Berthold Koletzko     

NH Hotel Budapest City
Vígszínház u. 3
H-1137 Budapest

Language: English
Registration Fee:  EUR 50.-

CME Credits: 11 points

Registration fees include:

   - accomodation

   - course materials
   - coffee breaks
   - lunches
   - welcome reception and dinner

Application Deadline: December 21, 2016


Mary Fewtrell            
Professor of Paediatric Nutrition, UCL Institute of Child Health, London, UK

Berthold Koletzko   

Prof. of Paediatrics, Ludwig-Maximilians-University of Munich.

Dr. von Hauner Children’s Hospital, Univ. of Munich Medical Center, Campus Innenstadt, Muenchen, Germany

Jan Taminau       

Professor of Paediatric Gastroenterology, Antwerp University Hospital, The Netherlands

Theo Stjinen    

Hoofd van de afdeling Medische Statistiek & Bio-informatica. Leiden University Medical Centre, Leiden, The Netherlands

Nick Croft        

Reader in Clinical Paediatric Gastroenterology, Centre for Immunobiology. Blizard Institute Barts and The London School of Medicine and Dentistry, London

Nedim Hadzic  

Professor and Consultant in Paediatric Hepatology, Paediatric Centre for Hepatology, Gastroenterology and Nutrition, King's College Hospital, London, UK 

Peter Szitanyi   

Department of Paediatrics and Adolescent Medicine of the First Faculty of Medicine and General, University Hospital, Charles University, Prague (Czech Republic)  


THURSDAY January 12, 2017

Afternoon - Arrival of Participants & Speakers

19.00               Welcome reception and dinner

FRIDAY  January 13, 2017

8.30-9.00         Welcome by Mary Fewtrell and Bert Koletzko (Course Chairs). Introduction of participants

9.00-9.30         Clinical Trials – An introduction: Trials on drugs, medical devices, and nutritional interventions: what is similar, what is different? (BK)

9.30-10.30       Pharmacokinetics and paediatric drug trials; placebos and extrapolation from adults. JT

10.30-11.00     BREAK and PHOTO

11.30-13.00     Essential statistical concepts for clinical trials, including power and sample size (TS)

Essential statistical concepts for clinical trials, including power and sample size. TS

13.00-13.45    Lunch

13.45-16.00    Designing my study: breakout groups (each student to do all 3 x 45 mins)

    1. Prevention of obesity in term infants  (MF)
    2. Orphan drug treatment in rare genetic liver disease (NH)
    3. Biologics treatment of children with inflammatory bowel disease (NC)

 16.00-16.30    COFFEE                   

16.30-17.15     Reporting back from break-out sessions (students)

17.15-18.15     PEDCCREN: Collaborative trials in IBD (NC)                       

19.00                 DINNER

SATURDAY January 14, 2017           

8.30-10.00       Various statistical topics: Analyses, Interim analyses, missing values, non-inferiority trials (TS).

10.00-10.15    COFFEE BREAK

10.15-11.00     Regulatory and legal aspects of drug trials in rare diseases – EMA perspective and the role of academics (JT)

11.00-11.45     Hepatology – trials in rare diseases (NH)

11.45-12.15    Specific Ethical Issues in Paediatric Trials (including use of)  MF   

12.15-12.45    Choice of outcome measures in nutrition trials (COMMENT) BK

12.45                LUNCH                                                                             

13.30-15.00     How should we interpret study results? -  breakout groups   

    1. Are author’s conclusions always supported by the data? A critical discussion (BK)
    2. What conclusions can be drawn from trials that reach a follow-up rate below 80% (TS/MF)
    (45 mins then swap)

15.00-15.30    Summary and conclusions

15.30               COFFEE and END OF COURSE

We thank our EPP Partners for their support:

For more information on our Education Partner Programme please click on the logos below.

Please find follwing the Event Report on the ESPGHAN Master Class Clinical Trials:

We thank our EPP Partners for their support:
For more information on our Educational Partner Programme please click on the logos below.