The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), through its Working Group for preparedness in paediatric clinical trials, is performing different actions aimed to facilitate the conduct of paediatric clinical studies focusing on identification and resolution of barriers to drug development in children. TEDDY Network is member of this Working Group and is providing its contribution in the activities of these paediatric experts.
In particular, five action points have been developed:
Action point 1: Review the current regulatory guidance and academic publications in relation to the conduct of trials in the paediatric population to identify discussion on preparedness.
Action point 2: Summarise previous initiatives on paediatric clinical trials (e.g. DIA/EFGCP, ACCELERATE, IMI2, ERN, Enpr-EMA and EPAC community) to identify existing valuable guidance on overcoming challenges.
Action point 3: Utilise deliverables from other Enpr-EMA WGs which have an impact on paediatric clinical trial conduct.
Action point 4: Development of a prompt guide/questionnaire to be used in interviews and brainstorming sessions on trial preparedness with stakeholder groups.
Action point 5: Development of preparedness-orientated guidance document including (a) narrative, (b) Q&A, (c) decision tree, (d) risk management strategy
TEDDY is participating in Action point 1 and Action point 4, providing its contribution in identifying the critical factors on successful completion of high-quality paediatric clinical trials.
For further information, please click here.