Objective
This proposal’s goal is to provide support to the Type 1 Diabetes TrialNet Canadian Affiliate site network through supporting the Toronto clinical center’s staff who in turn provide education, guidance and recruitment support to the Affiliate sites.
Background Rationale
Type 1 Diabetes TrialNet (TrialNet) is an international multicenter consortium that studies the development of type 1 diabetes (T1D) and performs clinical trials of interventions to modify the disease course that leads to beta cell loss before the diagnosis of type 1 diabetes and in the early post diagnosis period. TrialNet’s foundational study is the “Pathway to Prevention Study” which screens relatives of those living with T1D for diabetes for risk of developing diabetes. Over 250,000 relatives of individuals with type 1 diabetes have been screened for autoantibodies, a marker of risk of developing diabetes. In order to reach large numbers of relatives of those living with T1D, TrialNet’s clinical studies are led by multiple “Clinical Centres” who implement all of TrialNet’s studies and contribute to committees and other key functions. Each Clinical Centre supports a network of Affiliate sites who carry out the Pathway to Prevention Study and other studies based on local resources. Affiliate sites have contributed significantly to TrialNet’s Ab screening efforts, identifying up to 50% of participants. The Toronto Clinical Centre has established and supported a solid and successful Canadian TrialNet Network of Affiliate sites. Our network has focused on building capacity across the country in sites that have large pediatric and adult diabetes programs and research expertise with adequate facilities to accommodate TrialNet activities, carrying out all aspects of the Pathway to Prevention and other studies. This has led to Affiliate sites that once trained, can function with a high degree of independence and can participate in clinical trials. Our strong understanding of the unique demographical and geographical aspects of the Canadian Affiliate sites including cultural and language variability, has supported their success. The majority of diabetes care for children is provided at academic hospitals in most Canadian provinces. There are TrialNet Affiliates in many of these centres, providing TrialNet with access to a large proportion of the families of children living with type 1 diabetes in Canada. By targeting recruitment efforts through these centres, our ability to reach families of those with type 1 diabetes is increased. Each of the affiliate sites also collaborates with adult endocrinology programs locally to reach the family members are adults living with type 1 diabetes. We have developed a support system for the affiliate sites, in which we support participant travel for Pathway to Prevention eligibility/monitoring visits and clinical trials. In addition, we support Affiliate sites in organization and participation in recruitment events (such as Breakthrough T1D walks, screening events, etc.) by providing consultation and feasibility assessment, and monetary support to cover costs. We are uniquely able to support Canadian sites due to close relationships with the sites, our understanding of the Canadian healthcare system, diabetes community and regulatory requirements.
Description of Project
This proposal’s goal is to provide support to the Type 1 Diabetes TrialNet Canadian Affiliate site network through supporting the Toronto clinical center’s staff who in turn provide education, guidance and recruitment support to the Affiliate sites. This support will allow TrialNet to continue to have affiliate sites at major metropolitan areas across Canada, significantly enhancing the ability for Canadians to participate in TrialNet studies closer to their home. This will allow Canadian sites to continue to screen family members of those living with type 1 diabetes for diabetes related antibodies. Autoantibodies indicate that a person is at increased risk of developing diabetes. TrialNet studies will then provide follow up for participants identified as having increased risk and will be able to offer clinical trials to those who are eligible and interested.
Anticipated Outcome
Support to the Toronto TrialNet Clinical Center will allow dedicated staff to support the affiliate network which will greatly enhance Canadian's access to TrialNet studies.
Relevance to T1D
TrialNet conducts the largest study family members of those living with type 1 diabetes in order to identify those who are at increased risk, offer follow up and, importantly, runs clinical trials of therapies to modify the disease course of type 1 diabetes. The study group's work has led to the approval of the first drug that delays the onset of type 1 diabetes in those at high risk.