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Innovative approaches to investigator-initiated, multicentre paediatric clinical trials in Canada
  1. Lauren E Kelly1,2,3,
  2. Lawrence Richer4,
  3. Samina Ali5,
  4. Amy C Plint6,7,
  5. Naveen Poonai8,
  6. Stephen B Freedman9,
  7. Lisa Knisley3,
  8. Carolyn Shimmin10,
  9. Serena Hickes11,
  10. Geert W ’t Jong1,3,
  11. Petros Pechlivanoglou12,
  12. Martin Offringa12,
  13. Thierry Lacaze13,
  14. Terry P Klassen1,3
  1. 1 Pediatrics and Child Health, University of Manitoba, College of Medicine, Winnipeg, Manitoba, Canada
  2. 2 Clinical Trials Platform, George and Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada
  3. 3 Children’s Hospital Research Institute of Manitoba, Winnipeg, Manitoba, Canada
  4. 4 Paediatrics, University of Alberta, Edmonton, Alberta, Canada
  5. 5 Paediatrics and Emergency Medicine, Edmonton Clinic Health Academy, University of Alberta, Edmonton, Alberta, Canada
  6. 6 Children’s Hospital of Eastern Ontario, Ottawa, Ontario, Canada
  7. 7 Departments of Paediatrics and Emergency Medicine, The University of Ottawa, Ottawa, Ontario, Canada
  8. 8 Paediatrics and Internal Medicine, Schulich School of Medicine & Dentistry, London Health Sciences Centre, London, Ontario, Canada
  9. 9 Paediatrics, Alberta Children’s Hospital, Calgary, Alberta, Canada
  10. 10 Patient Engagement Lead, Knowledge Translation Platform, George and Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada
  11. 11 Parent Partner, University of Manitoba Children’s Hospital Research Institute of Manitoba, Winnipeg, Manitoba, Canada
  12. 12 Peter Gilgan Centre for Research and Learning, Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada
  13. 13 Pediatrics, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
  1. Correspondence to Dr Lauren E Kelly; lauren.elyse.kelly{at}gmail.com

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.

  • clinical trials
  • ethics (see medical ethics)
  • paediatrics

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors The idea for this work originates with the Innovation in Paediatric Clinical Trials (iPCT) steering committee. The Corresponding Author accepts full responsibility for the work. LEK led the first draft, NP and ACP drafting the ethics section, CS, LK, SA and SH drafting the patient engagement section and GWJ drafting the data safety monitoring board section. SBF, SA, LR, SB, PP, MO, TL and TPK contributed text to multiple sections and the interpretation of our report. All authors planned and designed the study, have access to the data, drafted the manuscript and controlled the decision to publish. The Corresponding Author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding The KidsCAN PERC Innovation in Paediatric Clinical Trials (iPCT) project is funded by the Canadian Institutes of Health Research - Strategy for Patient Oriented Research, Innovative Clinical Trials Multi-year Grant.

  • Competing interests The Innovation in Paediatric Clinical Trials (iPCT) project is funded by an Innovative Clinical Trials Multi-year Grant from the Canadian Institutes of Health Research, as part of the Strategy for Patient-Oriented Research and in partnership with the Alberta Children’s Hospital Research Institute, Centre Hospitalier Universitaire Sainte-Justine, Children’s Hospital Research Institute of Manitoba, Children’s Hospital of Eastern Ontario Research Institute, Hospital for Sick Children Research Institute, Research Manitoba, University of Western Ontario and Women & Children’s Health Research Institute. The authors have no conflicts of interest to disclose.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data is available at this time.

  • Patient consent for publication Not required.

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