Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study

ConclusionsThe completion of many paediatric studies required under the Paediatric Regulation has been delayed. Paediatric studies planned to be completed after marketing authorisation were associated with a lower likelihood of eventual completion, highlighting the need to examine the implementation of current policies in ensuring timely availability of important paediatric information.
Source: PLoS Medicine - Category: Internal Medicine Authors: Source Type: research