Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation.

Mandy WanElisa AlessandriniPaul BroganDespina EleftheriouAdilia WarrisRoger BrüggemannMark Turner

Published in: Clinical trials (London, England) (2022)

The European Clinical Trials Regulation gives a strong impetus to a risk-proportionate approach and offers a path for more efficient delivery of investigator-initiated paediatric clinical trials.

Keyphrases

clinical trial
phase ii
intensive care unit
emergency department
open label
phase iii
randomized controlled trial