Module232025

07/05/2025

ETHICS CHALLENGES IN PAEDIATRIC CLINICAL TRIALS My personal top 10 (based on ~600 protocols reviewed 2017-2023)

8. Communication of Trial Results (onus on participants, child to adult) 9. “Aging Out” (no process, incorrect process) 10. Paediatric Assent and Information Sheets (length, complexity)

The Organisation for Professionals in Regulatory Affairs

21

Post-trial access Communicating trial results – to parents and children

Many protocols refer parents and participants to EU or US regulatory websites, but….. − What is the separation between FPI and LPO? • Say 1 year treatment, 5 years enrolment, 6 mths for study report – 6½ years − PIs move, retire, die, departments close; parents separate, move house; children grow up • Keeping track of all concerned is often difficult − Neither EU nor US guidance on lay summaries make specific provisions for children • Enrolled as a child, report sent to adult

22

11