Clinical Research and Development

1.1 Program Objectives

This program supports projects that:

• Address gaps in clinical R&D aligned with D2R’s mission and strategic objectives.
• Foster innovation by promoting novel approaches to trial design and exploratory evaluations that accelerate therapeutic testing, knowledge translation, and regulatory approval.
• Encourage collaboration among academic, clinical, and industry partners to maximize translational impact.
• Leverage existing or ongoing clinical trials to generate added value through integrated ancillary R&D efforts.
• Promote Canadian leadership in clinical development by enabling early access to promising new therapies.

1.2 Clinical R&D Priorities

• Discovery and early-stage development of new therapeutics or the repurposing of existing drugs for unmet clinical needs.
• Biomarker identification or validation to guide therapy implementation, stratify patient sub-groups, and elucidate mechanisms of response or resistance.
• Integration of adaptive trial designs to accelerate evaluation, regulatory review, and translation of novel therapies or diagnostics.
• Development of diagnostic devices or delivery systems that advance precision medicine and improve patient outcomes.
• Collaborative projects that build on existing or ongoing trials and engage industry partners to co-develop diagnostics, technologies, or therapeutic strategies.

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 CFREF Administration Guide. 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

• McGill University faculty members.
• Eligible to hold Tri-Agency research funding.

Co-Investigator (Co-I) Eligibility

• McGill University faculty members.
• Researchers from D2R’s partner institutions (e.g., McMaster University, University of British Columbia, University of Ottawa, Université de Sherbrooke and Institut de recherches cliniques de Montréal). 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 McGill, other academic institutions, industry, government, or community organizations who contribute meaningfully to the project. Collaborators are not eligible to receive funding from D2R.

2.1 LOI Submission

Applicants must use the LOI template provided and submit the completed document to D2R.funding [at] mcgill.ca (subject: Clinical%20RD%20Program%20Letter%20of%20Intent) .

LOIs are accepted on a rolling basis. To ensure efficient evaluation, submitted LOIs may be reviewed in batches a few times per year, depending on the volume and timing of submissions.

2.2 LOI Evaluation

The evaluation will determine applicant and team member eligibility, and consider how well the proposed project:

• Aligns with D2R’s mission and the program objectives
• Addresses critical gaps in clinical R&D;
• Leverages existing or ongoing clinical trials infrastructure;
• Demonstrates meaningful collaboration among academic, clinical, and/or industry partners;
• Contributes to Canadian leadership in innovative clinical R&D.

2.3 LOI Notification

All applicants will be informed of the LOI evaluation outcomes by email.

Researchers invited to submit a full proposal will receive a link to the application form and all templates. Feedback on the LOI may be provided at the discretion of the review committee.

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

3.1 Online form

A link to the online form will be provided to invited applicants. The form includes the following sections:

• Principal Investigator’s identification
• Principal-Investigator’s 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’s Priority Disease Area (if applicable)
• Project duration
• Requested budget amount (maximum $500,000)
• Confirmed co-funding from partners and institutional commitment, if applicable.
• Associated clinical trial(s): Provide trial title, sponsor, stage, and outline how the project will coordinate with or receive support from the trial team.
• Private sector or industry partners: Describe any confirmed or prospective partnerships. Industry engagement is strongly encouraged.
• Description of research data; integration of data science and bioinformatics in project
• Research Ethics review requirement

3.2 Documents to Upload

Templates for each of the following documents will be provided to applicants who are invited to submit a full proposal.

• Project Description
• Biosketches.
  • 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
• Milestones and Timelines
• Reviewer Suggestions
• Letters of support (e.g., from trial leaders or partners confirming collaboration or financial/in-kind support) may be uploaded as a separate PDF. Limit: one page per letter.

3.3 Project Description Instruction

• Page limits: 9 pages in English and 10 pages in French, inclusive of references.
• Figures and images are allowed but must fit within the page limit.
• Letters of support are permitted only as outlined in Section 3.2. Other appendices are not permitted.
• Submissions exceeding the page limit (excluding support letters) will have the excess 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 R&D.
• Clearly describe how the project integrates with an existing or ongoing clinical trial, and how its integration strengthens the proposed R&D,
• If applicable, emphasize innovative approaches such as adaptive trial designs, biomarker discovery or novel delivery mechanisms.

B. Introduction and Background

• Situate the project within the current clinical R&D landscape
• Identify specific gaps in knowledge, technology, or practice that the project aims to address, particularly within D2R’s priority disease areas.
• Provide brief background on the associated clinical trial, highlighting its scientific relevance to the proposed research.

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).
• Describe the project’s objectives and methodologies, including innovative methods or technologies to be used.
• Explain how the research will be integrated with the identified clinical trial, including the nature of coordination with or support from the trial leadership.
• Provide a plan for addressing potential challenges or risks, including mitigation strategies.

D. Research Team and Collaborations

• Outline each team member’s role and how their contribution supports the project.
• Explain how existing infrastructure and partnerships (clinical, industry or institutional) will be used strategically to deliver high-impact results.
• Describe coordination strategies across sites or institutions.

E. Knowledge Translation and Impact

• Describe the project’s potential to generate significant clinical outcomes, improve patient care, or support regulatory or commercialization pathways.
• Describe how research findings will be communicated to relevant stakeholders (e.g., clinicians, patients, industry, policy makers).
• Highlight how the project contributes to Canadian leadership in clinical R&D.
• Describe anticipated Intellectual Property (IP) outcomes, data use or sharing strategies, and the role of any partners in knowledge mobilization or commercialization.

F. Equity, Diversity and Inclusion Plan

Describe your project-specific EDI Plan, addressing both research design and research practice.

EDI in Research Design

Thoughtful EDI in research design should include EDI considerations embedded throughout all research stages to enhance rigor and impact. Applicants should address:

• • Research Questions & Study Design: Explain how research questions consider the needs of diverse populations or specific equity-deserving groups. Describe how potential biases are identified and mitigated, whose perspectives are informing the project, and whether any inherent EDI biases impact the research question. If so, explain how the study design aims to address and mitigate these biases.
  • Data Collection & Analysis: Outline how data will be collected and analyzed, ensuring disaggregation where applicable (e.g., by age, gender, disability, ethnicity, socioeconomic status) to capture meaningful differences. Describe strategies to mitigate biases.
  • Knowledge Mobilization & Dissemination: Explain how research findings will be shared inclusively, ensuring accessibility for all groups, especially equity-deserving communities. If applicable, describe how therapies developed will be made accessible to diverse populations.

EDI in Research Practice

Thoughtful EDI in research practice should include EDI considerations concerning:

• • Team Composition and Recruitment: Describe efforts to assemble a diverse research team, including measures to mitigate systemic barriers in recruitment and enhance diversity. Outline existing strategies and planned improvements.
  • Training and Development: Explain how equitable access to training opportunities will be ensured for all team members (faculty, staff, trainees, and partners).
  • Inclusion and Accessibility: Describe current and planned measures to create an inclusive and accessible research environment where all members feel valued and integrated.
  • Mentorship and Institutional Support: Highlight available mentorship programs and how team members will support each other's professional development beyond research activities. Identify institutional policies and resources that promote EDI within the research setting.

G. Budget

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

H. References

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

4.1 Administrative Review

All submissions will undergo an administrative review to ensure the application is complete and adheres to program requirements.

4.2 Scientific Merit Evaluation

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

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

• Originality and Innovation: The extent to which the proposal introduces novel concepts or methods that advance clinical R&D. This includes innovation in diagnostics, therapeutic approaches, biomarker discovery, adaptive trial design, drug repurposing or delivery mechanisms — particularly where such innovations inform treatment decisions for specific patient sub-groups or address gaps affecting vulnerable populations.
• Feasibility of the Research Plan: The likelihood that the proposed project can be successfully completed within the given timeframe and budget. Considerations include the clarity of objectives, robustness of methodology, availability of resources, and management of anticipated challenges.
• Research Team Quality and Contributions: The qualifications, expertise, and composition of the research team, including collaborators. Emphasis will be placed on the team’s ability to execute the project effectively and its alignment with the proposed.
• Knowledge translation and Clinical Impact: The potential of the project to deliver meaningful clinical outcomes, improve patient care, or inform healthcare practices. Applicants should clearly describe how their findings will be translated into practice or potentially inform policy, and the anticipated benefits to target populations or health systems.

4.3 Equity, Diversity, and Inclusion (EDI) Review

EDI integration will be evaluated as part of the overall proposal assessment. Reviewers will assess how thoughtfully EDI is addressed in both:

• Research design (e.g., relevance to diverse populations, mitigation of bias, inclusive dissemination), and
• Research practice (e.g., diverse team composition, inclusive training, accessibility)

For proposals deemed fundable, EDI plans may undergo further review by experts. If revisions are required, Principal Investigators will be notified and asked to update their EDI plan prior to release of funds.

5.1 Funding Decision

The D2R Strategic Alignment Review Committee (SARC) will consider both the alignment with D2R’s 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).

5.2 Announcement of Results

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

5.3 Notice of Award

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

For additional information about the program or to discuss a project that might be relevant for consideration, please contact: D2R.Funding [at] mcgill.ca (subject: Clinical%20Research%20, %20Development) .