PT  - JOURNAL ARTICLE
AU  - Kelly, Lauren E
AU  - Richer, Lawrence
AU  - Ali, Samina
AU  - Plint, Amy C
AU  - Poonai, Naveen
AU  - Freedman, Stephen B
AU  - Knisley, Lisa
AU  - Shimmin, Carolyn
AU  - Hickes, Serena
AU  - ’t Jong, Geert W
AU  - Pechlivanoglou, Petros
AU  - Offringa, Martin
AU  - Lacaze, Thierry
AU  - Klassen, Terry P
TI  - Innovative approaches to investigator-initiated, multicentre paediatric clinical trials in Canada
AID  - 10.1136/bmjopen-2019-029024
DP  - 2019 Jun 01
TA  - BMJ Open
PG  - e029024
VI  - 9
IP  - 6
4099  - http://bmjopen.bmj.com/content/9/6/e029024.short
4100  - http://bmjopen.bmj.com/content/9/6/e029024.full
SO  - BMJ Open2019 Jun 01; 9
AB  - 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.