Preparedness of medicines’ clinical trials in paediatrics. Recommendations by the Enpr-EMA working group on trial preparedness. EMA/56009/2019.

Published by European Medicines Agency

Clinical TrialsPaediatricsMedicines

This document focuses on preparedness for individual trials. However, as a development plan would normally constitute a number of trials, it is implicit that the same elements would also be relevant for preparation of a complete plan. Trial “feasibility” is the likelihood of completing a trial in a timely manner. This document moves beyond the definition of “feasibility” to present a global determination of all aspects of a trial that need to be

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