Clinical Trials Fund | Pan-Canadian Clinical Trials Consortium

The 2021 Federal Budget announced funding for CIHR's Clinical Trials Fund (CTF), an integral component of Canada's Biomanufacturing and Life Sciences Strategy (BLSS). In support of this, the CTF will provide funding through three specific vehicles: platforms with the development of a pan-Canadian Clinical Trials Consortium; people with the funding of training platforms; and, projects through the funding of a broad spectrum of clinical trial initiatives.

As a signatory to the G7 Therapeutics and Vaccines Clinical Trials Charter, the Government of Canada has committed to supporting international efforts for improved clinical trial collaboration and cooperation to respond to future health emergencies. As a result of Canada's scientific expertise, high quality healthcare system, and research funding, and infrastructure, Canada is a global destination for important clinical trials. However, planned investments in the biomanufacturing ecosystem, including for clinical trial projects, networks, and capacity, will help to reinforce the existing scientific excellence and ensure that Canada is well-prepared for future health challenges.

The CTF will support research and researchers across the country to conduct the full spectrum of clinical trials including the development and testing of new drugs, treatments, and public health and health system interventions to prevent, detect, treat, or manage various diseases or medical conditions.

Platforms: A Pan-Canadian Clinical Trials Consortium

Canada has an array of clinical trial networks across disease areas which provide access to specialized research expertise and ensures that research activities are not duplicative. However, there remains a need for stability with improved coordination and collaboration infrastructure, as well as support for additional research networks in clinical areas where these structures do not currently exist.

The purpose of this funding opportunity is to support the creation of a pan-Canadian Clinical Trials Consortium that will strengthen coordination of clinical trials conducted in Canada, as well as Canadian participation in international clinical trials.

Consortium Structure

The Consortium will include a coordinating function that facilitates harmonization and engagement among clinical trial networks, stakeholders and other components of the CTF to accelerate clinical trials research, build synergies and mobilize knowledge to rapidly advance discovery and increase the impact of research in evidence-based decision-making. The coordinating function will:

• Identify gaps to support new clinical trial networks where needed, support and expand existing national networks, and promote relationships to leverage efforts and increase the efficiency and impact of research.
• Establish connections to international partners and consortia, promote Canadian research internationally, incorporate relevant knowledge and learning from other jurisdictions in a Canadian context, and seek out and support Canadian engagement in international clinical trials.
• Lead collaboration across member networks to establish resource and data sharing policies and increase efficiencies in research and related processes (including, but not limited to ethics review; contracts; common protocols; developing applications for trial funding; supporting consistent and valid patient-oriented outcomes); and streamlining knowledge mobilization/transfer mechanisms.
• Foster an equity, diversity, and inclusion (EDI) approach in clinical trials to ensure diverse individuals are included in clinical trials in a manner appropriate to the scientific questions under study so that the knowledge gained from research is applicable to all those affected by the researched diseases/conditions. This would include but is not limited to a lifecycle approach, to include children, older adults, and pregnant people; as well as populations often underserved by clinical trials.
• Support and contribute, where possible and relevant, to the efforts of the Clinical Trial Training Platforms and research projects funded through separate funding opportunities of the CTF.

Key Design Elements

Applications must incorporate all the following key design elements:

• Governance: The governance plan must include the following:
  • Mechanisms that seek out opportunities to engage additional organizations and that identify areas where clinical trial networks do not exist.
  • Engagement of multi-sectoral and diverse stakeholders. For information regarding principles of engagement, including approaches to compensation of People with Lived/Living Experience (PWLE), please refer to the SPOR Patient Engagement Framework.
  • A description of roles and responsibilities of key players, as well as mechanisms for decision making, and dispute and conflict resolution.
  • Concrete strategies to ensure the Consortium governance upholds principles of equity, diversity and inclusion, and Indigenous rights, as well as plans for oversight with external advice.
  • A dedicated Consortium Manager role, which must be filled within three months of the funding start date and remain filled for the duration of the grant.
• Consortium Expansion Funding: The Consortium will need to dedicate a portion of its funding to supporting new and existing clinical trial networks, their expansion, activities (including research) that will contribute to the objectives of the consortium and provide support for Canadian involvement in international collaborations.
• Pan-Canadian representation: The Consortium must include team members from across Canada to ensure appropriate pan-Canadian representation and capacity building. There must also be a process to bring together clinical trialists and other key stakeholders from across Canada in a collaborative and synergistic space that will advance clinical trials in Canada.
• International Linkages: The Consortium must plan to develop liaison activities with like-minded international networks to maximize the impact and international visibility of the Consortium, Canadian research and researchers.
• Knowledge Mobilization: In collaboration with stakeholders and existing Canadian clinical trial networks and platforms, the Consortium will take an impact-oriented approach to maximize the impact and benefit of the research being generated within and across members.
• Role and Contributions of Applicant Partners: CIHR recognizes that a broad range of partners may be relevant to this funding opportunity. The Consortium must describe the role of all applicant partners and how they will contribute to Consortium activities. Any consideration of risk and/or conflict of interest must be explained, as appropriate.
• Inclusion of Indigenous Peoples (First Nations, Inuit and Métis): Consortium members must include appropriate consideration of TCPS 2: Chapter 9 – Research Involving the First Nations, Inuit and Métis Peoples of Canada, as well as respecting principles of Indigenous data governance such as First Nations Principles of OCAP®1 (i.e., Ownership, Control, Access and Possession), the CARE Principles for Indigenous Data Governance, or other appropriate distinctions-based approaches, and demonstration of meaningful and culturally safe practices, plans and activities throughout the Consortium activities.
• Sex- and Gender-Based Analysis + (SGBA+): Sex and gender differences, as well as differences due to other intersecting identity factors (e.g., race; Indigeneity) and social processes (e.g., racism, ableism), are important factors affecting clinical trial results. CIHR requires that applicants consider sex as a biological variable and gender as a socio-cultural factor in the Consortium and related research activities and encourages applicants to consider sex and gender through an intersectional lens where appropriate.
• Health Disparities and Equity, Diversity and Inclusion (EDI): The Consortium is required to ensure appropriate representation of groups that are underrepresented in science, and those with a diversity of experiences, including First Nations, Inuit and Métis. This includes ensuring that the research environment is supportive and any systemic barriers are addressed effectively and swiftly (see the Best Practices in Equity, Diversity and Inclusion in Research for guidance and examples of systemic barriers).

The specific objectives of this funding opportunity are to:

• Establish a Pan-Canadian Clinical Trials Consortium that will enhance connections between domestic and international clinical trial networks to create efficiencies of scale and support high quality trials that are designed and sized to maximize their impact;
• Increase the impact of clinical trials through improved research design, increased recruitment, and enhanced clinical trial network capacity in Canada, including through the development and seed funding of new clinical trial networks where there are currently gaps;
• Build clinical trial capacity through training, mentorship, methods development, and information-sharing across member networks and other components of the CTF;
• Maximize research impact and knowledge mobilization within and beyond the Consortium to help ensure evidence is integrated in and used to inform health policy, decision making and planning; and
• Advance equitable access to clinical trials for Canadians regardless of geography, race/ethnicity, and socioeconomic status.

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