Innovative approaches to investigator-initiated, multicentre paediatric clinical trials in Canada. Issue 6 (27th June 2019)

• Record Type: Journal Article
• Authors: Kelly, Lauren E; Richer, Lawrence; Ali, Samina; Plint, Amy C; Poonai, Naveen; Freedman, Stephen B; Knisley, Lisa; Shimmin, Carolyn; Hickes, Serena; 't Jong, Geert W; Pechlivanoglou, Petros; Offringa, Martin; Lacaze, Thierry; Klassen, Terry P
• Is Part Of: BMJ open. Volume 9:Issue 6(2019)
• Publication Date: 2019-06-27
• Subjects: clinical trials -- ethics (see medical ethics) -- paediatrics; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-029024
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Data from clinical trials are needed to guide the safe and effective use of medicines in children. Clinical trials are challenging to design and implement in all populations, and children present additional considerations. Several regions including the UK, USA and Europe have established clinical trial infrastructure to capitalise on expertise and promote clinical trials enrolling children. Our objective is to describe the partnerships and operational considerations for the development of paediatric clinical trials infrastructure in Canada. We describe the design and conduct of four emergency room paediatric trials, with four separate sponsors, across four provinces in parallel. Operations discussed include multisite contract development, centralised risk-based data monitoring, ethical review and patient engagement. We conclude with lessons learnt, additional challenges and potential solutions to facilitate drug development for children in Canada.