Clinical trials are critical to Canada’s health systems as they provide the necessary evidence to advance medical treatments and can provide access to investigational or innovative research options for patients. Pediatric cancer trials face several challenges, including the relative rarity of childhood cancers. In addition, pediatric patients are often excluded from adult-focused trials. To address these challenges, the Canadian pediatric cancer community has worked to develop systems and strategies, including building capacity to facilitate academic investigator-initiated trials (IITs) and international collaborations with academic consortia focused on pediatric cancer. This capacity must continue to develop to meet evolving needs including regulatory requirements, the increased inclusion of new cellular and immunotherapies, and to develop better ways to ensure access for all children across Canada.

The C17 Council (C17), composed of the institutionally appointed heads of the 16 pediatric hematology, oncology and transplant and cell therapy programs across Canada, has provided crucial regulatory leadership and support for academic trials since 2003. This has enabled both Canada’s increased participation in international pediatric cancer cooperative groups, and the number of academic trials open across Canadian pediatric cancer centres.

C17 and ACCESS have partnered to continue to increase facilitation of and access to both Canadian- and internationally led academic pediatric cancer trials through the following:

• Development of a National Coordinating Centre (NCC) Model for Academic Pediatric Cancer Trials in Canada: Utilizing a NCC model for pediatric cancer trials in Canada will strengthen Canada’s ability to participate in international academic trials and streamline trial activities at participating centres. As the delegated national sponsor for international studies in Canada, C17 will formalize and implement the framework and additional infrastructure required to operate in evolving models of collaboration. C17 will pilot and refine this NCC model to activate several international academic trials for pediatric cancer patients in Canada, including the OPTIMISE trial (supported in part by ACCESS funding) and Innovative Therapies for Children and Adolescents with Cancer (ITCC) clinical trials from Europe.
• Sponsorship and Central Management of Canadian-Led IITs: Establishing and utilizing a centralized sponsor for Canadian-led IITs will streamline trial operations, enhance regulatory compliance, reduce duplication of effort, ensure consistent quality across participating centres and studies, and enable investigators from less-resourced institutions to lead trials. As a trial sponsor of Canadian-led IITs, C17 will enhance infrastructure and operational capacity to provide consistent oversight across all stages of trial development and execution, including for the DECRYPT BabyBrain trial (supported in part by ACCESS funding).
• Renewal of Risk-Based Monitoring Framework to Provide Central Support for Academic and Consortia-Led Clinical Trials in Canada: Planning the process for and the implementation of a renewed framework for the risk-based monitoring for academic and consortia-led clinical trials in Canada will streamline work and ensure readiness to align with evolving international standards while maintaining rigorous standards of patient safety, data quality and regulatory compliance. Utilizing a risk-based strategy, C17 will lead further development of the C17  monitoring program that includes central, remote, on-site and peer-to-peer monitoring. This will ensure the development of a program that supports remote access and decentralized trials and aligns with the adoption of ICH Good Clinical Practices E6:R3 in Canada

Through these efforts, the goal is to increase the number of academic pediatric cancer trials available in Canada and to streamline their implementation. This expansion of national capacity will support clinical research and ultimately, enable better access to promising therapies for children with cancer and their families in Canada.

For more information, please contact Tricia Schneider.