Catalyst Grant: SPOR Innovative Clinical Trials (iCT)

SPOR Innovative Clinical Trials Initiative

Clinical trials are research studies involving human participants that evaluate the efficacy, safety, and effectiveness of clinical treatments and devices (e.g., drugs, lifestyle interventions, etc.) on health outcomes. Clinical trials are important because they can: determine if new treatments or interventions are safe and what treatment/interventions work better; examine ways to detect disease, when to treat, and how to prevent health problems; evaluate ways to improve quality of life of people with illness or a chronic condition; and test a variety of interventions in different settings.

Despite well-documented advances in science and trial methodologies, clinical trials are not always adaptable to the diverse and constantly changing environments and research contexts. To address this, investments in clinical trials are vital, where multiple conditions are considered, and where evidence of a particular clinical intervention’s effectiveness for a diversity of populations can be demonstrated. In addition, there is a need to support the analysis of cost effectiveness of different treatments/interventions, in comparison to existing practice. The Innovative Clinical Trials (iCT) Initiative was launched at CIHR through SPOR in 2016 to address these considerations.

iCTs use designs that are alternative to traditional Randomized Controlled Trials (RCTs), with application in areas ranging from product development to health system improvement. For example, innovative clinical trials include the use of seamless trial designs, modeling and simulations to assess trial operating characteristics, the use of biomarker enriched populations, complex adaptive designs, Bayesian models and other benefit-risk determinations, and other novel designs.

iCT methods can reduce the cost of conducting trials, reduce the amount of time needed to answer research questions, and increase the relevance of research findings to a diversity of patients, healthcare providers and/or policy makers. iCTs funded through Canada’s Strategy for Patient Oriented Research focus on comparative effectiveness and implementation science research engaging a diverse and inclusive range of patients and other knowledge users in the research process in an equitable and accessible manner, among other requirements.

Some examples of iCTs include:

• Pragmatic trials;
• Observational trials;
• Registry-based randomized trials;
• Cluster randomized trials;
• Adaptive trials;
• Trials using Bayesian methods; or
• Small sample, biologically based trials (e.g., personalized medicine trials)

This catalyst grant funding opportunity aims to provide seed funding for the development of research collaborations across disciplines, including collaborations with PWLE, and to develop novel research perspectives in early research stages in preparation for larger SPOR iCT multi-year grants or operating grant applications. Catalyst grants support developing new and transformative methods relevant to iCTs, with the potential to generate high impact results.

Patient Engagement

Inclusive patient engagement must underlie all aspects of the project from the identification of the research question to the design, implementation and mobilization of knowledge from the results. A robust patient engagement plan that aligns with the SPOR Patient Engagement Framework and clearly describes the role of patients as active partners throughout the research process must be provided. SPOR promotes the view that, whenever possible, patients should be offered appropriate payment for their added value to the research activity to which they are contributing. This is reflected in the third guiding principle of the SPOR Patient Engagement Framework.

Health Disparities, Equity, Diversity and Inclusion (EDI)

Applications must include a patient-oriented research approach, and must address health disparities and EDI. Applicants are required to detail how they will achieve appropriate representation, equity, safety and inclusion of groups that have been historically excluded or underrepresented in health research (including clinical trials) throughout the research design and practices (e.g., recruitment strategies and processes, data analysis plans and approaches). Groups historically excluded or underrepresented in health research include:

• Those currently or at risk of experiencing poor health outcomes based on social economic factors (e.g., ethnic background, gender, disability, age, rural and remote location, homelessness, immigration status, socioeconomic status); and/or,
• Those identifying with historically excluded populations, including: women, pregnant people, children and youth (pediatrics), older adults, communities impacted by racism, people living with disabilities, members of 2SLGBTQI+communities.

Sex and gender differences, as well as differences due to other intersecting identity factors (e.g., cultural, ethnic) and social processes (e.g., racism, ableism), are important factors affecting clinical trial results. CIHR requires that applicants outline how sex, gender and other diverse and intersecting identity factors are considered within their research design, including plans in analyzing data.

Life Course Approach

Applicants are required to outline how they have considered inclusion/exclusion of individuals throughout the life course (e.g., children, older adults, and pregnant people) in trial design and results. If a life course approach is not appropriate or feasible for the design, provide rationale.

Objectives

The specific objectives of this funding opportunity are to provide seed funding to:

• build relationships among researchers, PWLE, communities, health care professionals and others with a view to developing inclusive, equitable and culturally safe iCTs;
• mobilize research collaborations aimed at identifying priorities for iCT research; and,
• develop new and transformative methods relevant to iCTs, with the potential to generate high impact results.

Examples of activities that might be conducted under this funding opportunity include (but are not restricted to):

• Building relationships through meaningful engagement and consultation with different stakeholders and partners and conducting engagement sessions to inform iCT research design and culturally safe approaches;
• Planning and execution of pilot projects or feasibility studies to demonstrate proof of concept and/or generate preliminary data;
• Developing and/or validating new tools, methodologies and/or protocols.

Eligibility to Apply

For an application to be eligible, all the requirements stated below must be met:

1. The Nominated Principal Applicant (NPA) must be one of the following:
   1. an independent researcher or a knowledge user (including a PWLE) affiliated with a Canadian postsecondary institution and/or its affiliated institutions (including hospitals, research institutes and other non-profit organizations with a mandate for health research and/or knowledge translation) at the time of funding.
      • if the NPA is a knowledge user, there must be at least one Principal Applicant who is an independent researcher;
      OR
   2. an individual affiliated with an Indigenous non-governmental organization in Canada with a research and/or knowledge translation mandate;
      OR
   3. an Indigenous non-governmental organization in Canada with a research and/or knowledge translation mandate.
2. The NPA (individual) must have their substantive role in Canada for the duration of the requested grant term.
3. The Institution Paid must be authorized to administer CIHR funds before the funding can be released (see Administration of Funds).
4. The NPA* must have successfully completed one of the sex- and gender-based analysis training modules available online through the CIHR Institute of Gender and Health and submit a Certificate of Completion. Select and complete the training module most applicable to your project. Applicants are encouraged to review the page "How to integrate sex and gender in research" on the CIHR website. See How to Apply for more details.

   *Organizations as NPAs: For organizations applying as the NPA, a representative of the organization must complete the training module on the organization’s behalf.

5. The research team must include at least four distinct Principal Applicants (PA) /Principal Knowledge Users (PKU) (the NPA can count as one of these applicants), covering each of the categories listed below:
   1. A Patient (PWLE)
   2. One researcher;
   3. A health care provider (e.g., physicians, nurses, occupational therapists, traditional healer, pharmacists, social workers, physiotherapists, psychologist, and other health professionals).
   4. A health system decision maker (i.e., individual empowered to engage with the research project and serve as a conduit of information to and from their respective health system, health care institution, health care centre [including health or wellness centres on-reserve or in urban centres], etc.).
6. For any application involving research with Indigenous Peoples, including applications to the Indigenous Health Research Pool:
   • A member of the research team (the NPA, PA or PKU) must self-identify as Indigenous (First Nations, Métis or Inuit) and/or provide evidence of having meaningful and culturally safe involvement with Indigenous communities. A one page document describing how they meet this requirement must be submitted as an “Other” attachment (see How to Apply for more details).
   • In addition, for the Indigenous Health Research Pool, at least one knowledge user must be affiliated with First Nations, Inuit or Métis and/or urban Indigenous communities or organization. This may be an Indigenous Elder and/or an Indigenous Knowledge Keeper.
7. An applicant can only submit one application as an NPA but can participate in any number of applications in other applicant roles.

Note: Participants, including Elders and/or Indigenous Knowledge Keepers, may participate on an application in a Collaborator role without the need to secure a CIHR PIN. Follow the instructions in the How to Apply section that pertain to Collaborators and indicate their role in the participant table. Elders and/or Indigenous Knowledge Keepers' contributions to the proposed activities and their meaningful engagement must also be captured in the research proposal to address the points outlined in the evaluation criteria. Please note, names of Collaborators do not appear in CIHR funding decision databases and documents.