1.1 Program Objectives

This program supports projects that:

• Address gaps in clinical R&D that align with D2R鈥檚 mission and strategic objectives.
• Foster Innovation by promoting novel approaches to trial design and exploratory evaluations that accelerate testing, knowledge translation, and regulatory approval of treatments.
• Demonstrate collaboration to achieve translational outcomes. Partnerships between academic researchers, clinicians, industry and other stakeholders are encouraged to ensure the rapid translation of research findings into high-impact clinical outcomes.
• Promote Canadian Leadership: Ensure that clinical development takes place in Canada, providing early access to promising new therapies for Canadian patients.

1.2 Clinical R&D Priorities

• Research focused on the discovery and early-stage development of new therapeutic agents or the repurposing of existing drugs for unmet clinical needs.
• Studies aimed at identifying or validating biomarkers to enhance the implementation of novel therapies, targeting interventions to specific sub-populations, and providing insights into mechanisms of response or resistance.
• Projects that integrate adaptive trial designs to accelerate the evaluation, regulatory approval, and knowledge translation of novel therapies or diagnostics.
• Development of diagnostic devices or delivery systems that facilitate precision medicine, reduce diagnosis time, or improve therapeutic outcomes.
• Collaborative research with industry partners to develop new diagnostics, technologies, or therapeutic approaches based on clinical trial data.

1.3 Award Value and Duration

• Award Value/Project: Maximum of $500,000 per project.
• Project Duration: up to three years (non-renewable).

1.4 Eligible Expenses

Expenses are for direct costs of research and must comply with the . Eligible expenses include:

• Salaries, benefits, and stipends for highly qualified personnel (HQP)
• Incentives for study participants and honoraria for expert advisors
• Professional & technical services and consulting fees
• Equipment (up to $15,000 combined maximum cost for all pieces of equipment).
• Supplies, consumables
• User fees (including use of core facilities)
• Computers and electronic communications
• Travel and subsistence for field work, conferences and other research-related travel
• Dissemination of results & networking

1.5 Applicant Eligibility

Principal Investigator (PI) Eligibility

• 捆绑SM社区 faculty members.
• Eligible to hold Tri-Agency research funding.

Co-Investigator (Co-I) Eligibility

• 捆绑SM社区 faculty members.
• Researchers from D2R鈥檚 partner institutions (e.g., McMaster University, University of British Columbia, University of Ottawa, Universit茅 de Sherbrooke). These researchers must be included in the list provided by the partners and approved by D2R.
• Eligible to hold Tri-Agency research funding.

Collaborators

• Individuals from 捆绑SM社区, other academic institutions, industry, government, or community organizations who contribute meaningfully to the project. Collaborators are not eligible to receive funding from D2R.

The full application consists of an online form and specific documents to upload.

2.1 Online form

The online form Includes the following sections:

• Principal Investigator鈥檚 identification
• Principal-Investigator鈥檚 Early Career Researcher status
• Team member identification
• Full Project Title
• Lay Title
• Five keywords
• Lay Abstract (up to 100 words)
• Alignment with D2R Foundational Axes
• Alignment with D2R鈥檚 Priority Disease Area (if applicable)
• Project duration
• Requested budget amount
• Associated clinical trial(s), if applicable
• Private sector(s) involved, if applicable
• Description of research data; integration of data science and bioinformatics in project
• Research Ethics review requirement

2.2 Documents to Upload

• Project Description (Template)
• Biosketches. (Template)
  • A biosketch is required for the Principal Investigator, each Co-Investigator, and any named Postdoctoral Fellow(s).
  • Biosketches for Collaborators are not required
• Budget and Justification (Template)
• Milestones and Timelines (Template)
• Reviewer Suggestions (Template)

Use the template for each document.

2.3 Project Description Instruction

• Page limits: 8 pages, inclusive of references.
• Figures and images may be used but must fit within the stated page limit.
• Appendices are not permitted.
• Submissions that exceed the maximum page limit will have the extra pages removed prior to review.

A. Scientific Summary

• Provide an overview of the project's objectives, methods, and anticipated outcomes, highlighting its potential to advance clinical research and development.
• Clearly describe how the project aligns with D2R's mission and contributes to the program鈥檚 objectives. If applicable, emphasize innovative approaches, adaptive trial designs, or biomarker discovery.

B. Introduction and Background

• Situate the project within the current clinical research and development landscape, identifying gaps in knowledge, technology, or practice that the project will address.

C. Proposal

• Clearly articulate how the project aligns with one or more of the identified priorities (e.g., novel therapeutics, biomarker discovery, adaptive trial designs), including innovative methods or technologies to be engaged.
• Detail the project鈥檚 objectives and methodologies, and how they will achieve the desired outcomes.
• Explain how the project will utilize existing resources and collaborations to deliver high-impact results within the program鈥檚 specified timeframe and budget.
• Identify potential challenges and provide a mitigation plan.
• Briefly describe the objectives, timelines, milestones and deliverables of the project over the course of funding. Refer to the Milestones and Timelines (Gantt chart) uploaded.
• Outline how Equity, Diversity, and Inclusion (EDI) principles have been integrated into the research design, addressing relevant factors such as sex, gender, race, physical ability, and age. If EDI considerations do not apply, provide a justification and rationale for their exclusion.

D. Research Team and Collaborations

• Outline the roles of each team member and how their contributions will support the project.
• Detail how the team will coordinate activities, particularly if members are based at different institutions.
• Explain collaboration strategies and how resources will be shared.
• Summarize existing or potential partnerships and funding opportunities that could support the project's goals.
• Describe what measures are being implemented to support EDI in research practice (e.g. recruitment practices, team composition, training and mentorship opportunities, knowledge dissemination strategies).

E. Knowledge Translation and Impact

• Describe the project鈥檚 potential to generate significant clinical outcomes, improve patient care, or advance therapeutic approaches.
• Describe how research findings will be shared with relevant stakeholders (e.g., clinicians, patients, industry, policy makers) to maximize impact.
• Explain how the project will contribute to developing clinical R&D leadership in Canada
• Describe any Intellectual Property (IP) that you expect the project may generate, and any other potential contributors to this activity (e.g., industry partners, collaborators).

F. Budget

• Provide a high-level summary of the budget and justifications, especially for expenses which may require additional context.

G. References

• List only works cited in the Project Description.
• Include DOIs where available

3.1 Administrative Review

An administrative review of each submission will be conducted to verify both Principal Investigator and Co-Investigator(s) eligibility and application completion.

3.2 Strategic Alignment and Scientific Merit Evaluation

Applications will be evaluated by external experts and the D2R Strategic Alignment Review Committee (SARC).

A. Alignment with D2R鈥檚 Mission and Program Objectives
This criterion will be assessed as Yes or No, based on whether the proposal demonstrates clear and substantial alignment with D2R鈥檚 mission to advance clinical research and development. The evaluation will confirm how the project addresses critical gaps and supports the program鈥檚 key objectives, such as fostering innovation, leveraging existing resources, enhancing collaboration, and ensuring Canadian leadership in clinical R&D.

B. Scientific Merit
Each of the following criteria will be scored on a scale of 1 (poor) to 20 (excellent):

1. Originality and Innovation: The extent to which the proposal introduces novel and creative approaches that push the boundaries of clinical research and development. Projects should contribute to the advancement of new diagnostics, therapies, or preventive measures, particularly in areas like biomarker discovery, adaptive trial design, drug repurposing or innovative delivery mechanisms.
2. Feasibility of the Research Plan: The likelihood that the proposed research plan will successfully achieve its stated objectives within the given timeframe and budget, considering the available resources, collaborations, and any anticipated challenges.
3. Research Team Quality and Contributions: The expertise and capabilities of the research team and collaborators, including how the team is organized to execute the project. Emphasis will be placed on how well the team鈥檚 skills and collaborations align with the project鈥檚 goals and the potential for delivering impactful results.
4. Knowledge translation and Clinical Impact: The potential of the project to generate significant clinical outcomes, improve patient care, or advance therapeutic approaches. Projects should demonstrate how their findings could lead to tangible benefits for patient populations or healthcare systems, particularly in the context of knowledge translation.

Note Regarding: Integration of Equity, Diversity, and Inclusion (EDI) Considerations
EDI considerations will be evaluated by reviewers as part of the overall proposal assessment. For projects deemed fundable, EDI integration will undergo further review by experts in the field. Principal Investigators will be notified of any deficiencies (e.g., insufficient EDI integration) and will be required to revise and satisfactorily update these sections before the release of funds.

4.1 Funding Decision

The D2R Strategic Alignment Review Committee (SARC) will consider both the alignment with D2R鈥檚 mission and objectives, and scientific merit evaluations in its funding decisions. Among the aligned projects, those with the highest scientific merit scores will be prioritized for funding. Funding will be approved by the 2R Research Steering Committee (RSC)

4.2 Announcement of Results

Principal Investigators will be informed of the results and EDI considerations by email.

4.3 Notice of Award

Successful applicants will receive a Notice of Award, which details the terms, conditions, and reporting obligations.