Europe – EMA finalizes pediatric trial preparedness framework

The European Medicines Agency (EMA) has released the final version of a framework for pediatric clinical trial preparedness. The final document aims to “increase the likelihood of a smooth and timely course of a paediatric clinical trial, integrating information from multiple stakeholders on what is possible within individual studies and therefore also for the overall drug development plan within which a trial is embedded,” according to EMA.
This framework’s release follows a September 2019 draft version that was open for a 2-month public consultation period. Considerations posed by stakeholders during that period were included in the final document, said EMA. (Related: EMA consults on pediatric study preparedness framework, Regulatory Focus 12 September 2019)
The preparedness framework tops a list of priorities for EMA’s European Network of Pediatric Research (Enpr-EMA), whose overarching goal is to facilitate studies that increase the availability of medicines for children.
Preparedness for clinical trials involving children can avoid trial delays and even failure, noted the agency, adding that the complexities of pediatric trials means that foresight and planning are key. “For the majority of pediatric clinical trials problems can be addressed by using all available data to estimate what is possible using a structured approach,” said EMA in the framework…