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     

Venue:
NH Hotel Budapest City
Vígszínház u. 3
H-1137 Budapest
Hungary

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


Faculty

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

 m.fewtrell@ucl.ac.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

Berthold.Koletzko@med.uni-muenchen.de


Jan Taminau       

Professor of Paediatric Gastroenterology, Antwerp University Hospital, The Netherlands

j.a.taminiau@amc.uva.nl

Theo Stjinen    

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

T.Stijnen@lumc.nl

Nick Croft        

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

n.m.croft@qmul.ac.uk

Nedim Hadzic  

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

nedim.hadzic@kcl.ac.uk 


Peter Szitanyi   

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

Peter.Szitanyi@vfn.cz




Programme

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.