Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery.

Sabah AttarAngie PriceCollin HovingaBreanne StewartThierry Lacaze-MasmonteilFedele BonifaziMark A TurnerRicardo M Fernandes

Published in: Therapeutic innovation & regulatory science (2024)

We found disparity in drivers, methodology and metrics. Tackling this disparity will result in a unified approach to addressing delays in paediatric drug approvals. Collaborative work to define inter-operable metrics globally is outlined.

Keyphrases

quality improvement
clinical trial
intensive care unit
emergency department
phase ii
phase iii
patient safety
study protocol
randomized controlled trial
open label