EMA Releases Final Framework for Pediatric Trial Preparedness
The European Medicines Agency (EMA) has released a final version of a pediatric trial preparedness framework that outlines recommendations on data collection, structured approaches for designing and conducting pediatric research, and advice on how to involve patients’ and children’s advisory groups in pediatric clinical trials as a means of supporting preparedness efforts.
In the final document, the EMA states the framework provides key factors that may increase the “smooth and timely course” of a pediatric trial with a focus on approaches for preparedness for individual trials.
In the framework, the EMA also offers advice on how to involve other contributors, including expert groups and societies as well as regulators, in the preparedness process. The EMA also calls for the pediatric research community to improve selection and management of sites, addresses travel considerations for trial participants and discusses how to mitigate the burden of participation on children and their families.
The final EMA framework can be found here: https://bit.ly/2GA4s7P.