New recommendations on clinical trial preparedness in paediatrics
Published on 07/09/2020
The EMA published new recommendations on clinical trial preparedness in paediatrics in August 2020, a result of a European Network of Paediatric Research (Enpr-EMA) working group. These recommendations are a structured assessment of contributing factors that enable efficient conduct of individual clinical trials in paediatrics and were developed for sponsors, principal investigators and triallists.
The key factors taken into consideration in the document include: the data collection, the involvement of different stakeholder groups, the need for a structured approach, the use of appropriate resources as well as the methods for preparing plans and studies.
See the full document: Preparedness of medicines’ clinical trials in paediatrics.
