Innovative approaches to investigator-initiated, multicentre paediatric clinical trials in Canada

Authors

Lauren E. Kelly, University of Manitoba
Lawrence Richer, University of Alberta
Samina Ali, University of Alberta
Amy C. Plint, Children's Hospital of Eastern Ontario, Ottawa
Naveen Poonai, London Health Sciences CentreFollow
Stephen B. Freedman, Alberta Children's Hospital
Lisa Knisley, Children's Hospital of Winnipeg
Carolyn Shimmin, George & Fay Yee Centre for Healthcare Innovation
Serena Hickes, Children's Hospital of Winnipeg
Geert W. Jong, University of Manitoba
Petros Pechlivanoglou, Hospital for Sick Children University of Toronto
Martin Offringa, Hospital for Sick Children University of Toronto
Thierry Lacaze, Cumming School of Medicine
Terry P. Klassen, University of Manitoba

Document Type

Article

Publication Date

6-1-2019

Journal

BMJ Open

Volume

9

Issue

6

URL with Digital Object Identifier

10.1136/bmjopen-2019-029024

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.