Clinical trials are a core component of healthcare innovation, as they provide critical information on the safety, effectiveness and appropriateness of treatments or interventions. Clinical trials enable us to improve outcomes for our patients and can provide access to new approaches to treatment for patients – which is particularly important for patients with hard-to-treat cancers. However, despite these benefits, clinical trials for children, adolescents and young adults (CAYA) with cancer in Canada are relatively sparse.

‘Investigator-initiated trials’ (IITs) are a type of academic clinical trial that are developed and led by an academic clinician/researcher with support from their respective institution (as opposed to ‘consortia-sponsored trials’ that are led by academic groups, or ‘industry-sponsored trials’ that are led by a pharmaceutical or medical device company). Currently, IITs make up a very small proportion of the clinical trials in Canada, due, in part, to a lack of institutional support or expertise to plan and execute an IIT.

In the near-term, this initiative will directly support Canadian investigators in the development of their own clinical trials by identifying promising early clinical trial concepts of benefit to Canada’s CAYA community and directly assist in developing them into competitive funding proposals or fully-fledged clinical trial protocols.  This support will directly increase the number of clinical trials for CAYA with cancer in Canada over the next few years.

In the longer-term, this initiative will also provide critical support to Canadian investigators in the development of future clinical trials through the creation of an IIT toolkit that equips investigators with the essential documents and resources needed to develop a clinical trial proposal or protocol. It will also provide guidance on drug access strategies, manufacturing considerations, funding and grant opportunities, budget development, and operational planning for investigator-initiated trials.

Increased expertise, potentially with new lead trial investigators and institutions, will strengthen Canada’s collective capacity to develop, initiate and lead novel IITs that serve our Canadian pediatric cancer community. And by strengthening this capacity, this initiative will help ensure that children with cancer and their families in Canada have access to the latest advances in cancer care – here at home.