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2013-07-04
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WORKSHOP - Extrapolation and Evidence Synthesis in the Development and Therapeutic Use of Medicines in Children
11th June 2013 – Strathclyde University, Glasgow, UK

The GRiP Paediatric Clinical Studies team (Work Package 4) held a workshop at the University of Strathclyde, Glasgow, UK on Extrapolation and Evidence Synthesis in the Development and Therapeutic Use of Medicines in Children.

 

The primary objective of the workshop was to review the current methodologies for evidence generation and evidence synthesis in paediatric research, including opportunities for extrapolation and optimisation of experimental protocols. Attention was also given to issues such as the choice of comparators when defining efficacy and safety in children. 

 

Please find the programme of the workshop. Click on the links to download the presentations that were given by the workshop participants.

 

PROGRAMME

 

09:00 - Welcome and objectives of the workshop

09.10 - Introduction to the GRiP Network of Excellence

Dr Oscar Della Pasqua (University of Leiden, The Netherlands, GRiP – WP4)

09.20 - GRiP perspective on evidence generation and synthesis

Dr Oscar Della Pasqua (University of Leiden, The Netherlands, GRiP – WP4)

 

SESSION 1 - EVIDENCE GENERATION

09.45 - Use of nonlinear mixed effects modelling and simulation for data analysis and study design optimisation.

Dr Ann Vermeulen (J&J, Beerse, Belgium)

10.15 - Incorporation of historical data as priors in hierarchical models for the evaluation of treatment effect

Dr Alberto Russu (J&J, Beerse, Belgium)

10:45 - Panel Discussion - Q&A

Discussant: Prof Gérard Pons (University Paris Descartes, France; Paediatric Committee, EMA, UK)

11:15 - Coffee break

 

SESSION 2 - EVIDENCE SYNTHESIS

11.35 - Role of meta-analysis in evidence synthesis: an example based on dose selection for antibiotics

Dr Charlotte Barker (St George's Hospital, London, UK)

12.05 - Defining the level of evidence in the evaluation of risk

Dr Yoon Loke (University of East Anglia, UK)

12.35 - Panel Discussion - Q&A

Discussant: Dr Oscar Della Pasqua (University of Leiden, The Netherlands; GRiP – WP4)

13:05 - Lunch

 

SESSION 3 - FOCUS ISSUES - RARE DISEASES AND NEONATOLOGY

14.05 - Requirements for the evaluation of rare diseases

Elin Haf Davies (European Medicine Agency, UK)

14.35 - Clinical trials and evidence generation in neonates

Hitesh Pandya, University of Leicester, UK 

15.05 - Panel Discussion - Q&A

Discussant: Prof Evelyne Jacqz-Aigrain (Hôpital Robert Debré, Paris) 

15.35 - Tea break

 

SESSION 4 - REGULATORY and PATIENT PERSPECTIVES

15.50 - The Paediatric Investigational Plan and the Pediatric Study Plan

Dr Christoph Male, (European Medicine Agency, UK) 

16.20 - Effective engagement and communication with patient/parents 

Adriana Ceci (GRiP Executive Board Member; Paediatric Committee, EMA, UK) 

16.45 - Panel Discussion - Q&A

Discussant: Elin Haf Davies (European Medicine Agency, UK)

17.15 - Closure

Prof Gérard Pons (University Paris Descartes, France. GRiP WP4 member)