Cancer Research Society Investigator-Initiated Clinical Trials

Eligibility

Project Eligibility Criteria

The IIT Program supports investigator-led interventional clinical trials addressing clinically meaningful questions with the potential to prevent cancer or improve cancer care. Projects must involve direct testing of an intervention in human participants and may include early-stage exploratory studies as well as Phase I or Phase II clinical trials. All proposals must be operationally ready with a clear and feasible implementation plan at the time of submission.

Eligible clinical trials may include, but are not limited to:

• Cell-based therapies, biologics, and immunotherapies: Antibodies, tumour-targeted vaccines, engineered cell therapies, immune-based interventions, and novel targeted therapies. 

• Treatment optimization studies: Modified treatment sequences, dose or schedule optimization, combination therapies, radiotherapy innovations, or surgical approaches.

• Biomarker- or diagnostic-driven interventions: Genomic or molecular stratification, predictive/prognostic biomarkers, biomarker-based treatment assignment, or response-monitoring strategies. 

• Pediatric and adolescent/young adult cancers (AYA) oncology trials: Studies addressing rare pediatric cancers, age-specific clinical needs, or care gaps in adolescents and young adults.

• Supportive care, survivorship interventions, and device-based approaches: Approaches to improve symptom management, reduce treatment-related toxicity, enhance quality of life, support long-term survivorship, or evaluate supportive care relevant medical devices. 

• Prevention and early detection clinical studies: Trials evaluating chemoprevention, vaccines, screening innovations, or diagnostic biomarkers when conducted in an interventional, clinical setting.

Applicant Eligibility Criteria

To be eligible to apply to the IIT Program, the Principal Investigator (PI) must: 

• Be affiliated with a recognized Canadian healthcare or academic institution capable of administering research funds. 

• Hold an appointment that permits them to lead an investigator-initiated interventional clinical trial in Canada. 

• Demonstrate appropriate experience in clinical research (e.g., clinical trials, clinical epidemiology, biostatistics) or have access to qualified co-applicants or collaborators who collectively provide the necessary expertise. 

• Additional criteria may apply according to the funding partner(s) Multidisciplinary collaboration is strongly encouraged. Cross-Canada partnerships are particularly valued, as they enhance national reach, feasibility, and impact. 

Use of Funds: All funding provided through the IIT Program must be administered in Canada. Funds may not be transferred to institutions outside the country. International collaborators are permitted, but the trial must be designed, led, and primarily conducted in Canada.

Projects must be supported by a qualified, multidisciplinary team with the expertise required to design, execute, analyze, and disseminate the clinical trial. Teams should include, as appropriate: 

• Clinical investigators with domain expertise 

• Biostatistical and methodological experts 

• Operational and trial management personnel 

• Data management and regulatory personnel 

• Knowledge translation specialists 

• People with lived and living experience of cancer

To support capacity building within Canada’s clinical research ecosystem, the inclusion of trainees and early-career investigators is required. Their roles should be clearly described and meaningful.

Each applicant may submit one (1) application as Principal Investigator per competition, regardless of funding stream.

Applicants may participate as a Co-Applicant on up to two (2) applications across any funding stream.

There is no limit to the number of applications an individual may join as a Collaborator.

Summary

Investigator-initiated clinical trials (IITs) play a critical role in advancing cancer care in Canada. Designed and led by clinicians and scientists, these trials address important, practice-relevant questions and priorities relevant to people affected by cancer that may not be fully explored in industry-led trials. Despite their importance, investigator-initiated trials remain persistently underfunded in Canada, particularly at early stages of clinical development. Many promising ideas encounter barriers to clinical testing because of limited funding, fragmented support, and the operational complexity of investigator-led trials.

To address this gap, the Cancer Research Society (CRS), in collaboration with co-leads Canadian Cancer Society (CCS) and the Terry Fox Research Institute (TFRI), have launched the Canadian Investigator-Initiated Trials Program. 

This unprecedented collaboration also brings together Lotte & John Hecht Memorial Foundation, Génome Québec, SickKids Garron Family Cancer Centre, Kindred Foundation, Childhood Cancer Canada, BioCanRx, and the Montreal Cancer Institute, all committed to advancing clinical research and turning promising ideas into tangible results for patients. 

This national initiative is designed to strengthen Canada’s cancer clinical research ecosystem by supporting high-quality, investigator-driven clinical trials that address unmet clinical needs and have the potential to improve care and outcomes for people affected by cancer. To meet the diverse needs of investigator-initiated clinical research, the program includes two distinct funding streams: Proof-of Concept (PoC) Trials and Full Clinical Trials. Applicants must select the funding stream that best aligns with the stage, scope, and objectives of their proposed research.

Proof-of-Concept (PoC) Trials:

Proof-of-Concept trials are intended to support early-stage, exploratory clinical studies that establish feasibility, safety, and preliminary evidence of efficacy. These projects are typically hypothesis-generating and aim to de-risk innovative approaches prior to larger-scale evaluation. 

Key characteristics: 

• Early-phase or exploratory clinical studies 

• Limited patient populations 

• Focus on feasibility, safety, and/or preliminary signals of efficacy 

• May include novel interventions, combinations, or biomarker-driven approaches 

Funding parameters: 

• Up to $500,000 

• Maximum duration of 3 years

Full Clinical Trials:

Full Clinical Trials are intended to support more advanced investigator-initiated studies that build on existing evidence and are positioned to influence clinical practice or standard of care.

Key characteristics: 

• Later-phase or more mature clinical studies 

• Strong scientific and clinical rationale supported by preliminary data 

• Designed to generate robust evidence on efficacy, safety, or comparative effectiveness 

• Potential to inform clinical guidelines or practice 

Funding parameters: 

• Up to $2,000,000 

• Maximum duration of 5 years

Application Process

1. LOI: Submission of a Letter of Intent (LOI) is mandatory for both funding streams and is required to access the Full Application stage. LOIs must be submitted through the CRS Portal – ProposalCentral by June 4, 2026 at 9:59 p.m. (MT). The LOI must be submitted by the Principal Investigator (PI) from the managing institution. 

   Only applicants whose LOIs are deemed eligible and aligned with the IIT Program will be invited to submit a Full Application. 

   Funding Stream Differences for the LOI (PoC vs Full Trial):

   For the LOI, both funding streams provide the same set of fields, but applicants must indicate which stream they are applying to: 

   • Proof-of-Concept (PoC) Trial 

   • Full Clinical Trial (Phase I–II) 

   A simple drop-down selection will route applicants to the correct downstream Full Application requirements.

2. Full Application: Only applicants who submitted an LOI and were subsequently invited may submit a Full Application. Full Applications must be submitted by September 16, 2026 at 9:59 p.m. (MT) through ProposalCentral. Applications not compliant with instructions, including page limits, formatting, or missing documents, may be administratively rejected prior to scientific review.

Overhead

Not eligible.

Pre-application deadlines

RSO internal deadline

Pre-application program deadline

Application deadlines

RSO detailed review deadline

RSO final internal review deadline

Program application deadline

NOTE: Consult your Faculty Associate Dean (Research) (ADR) regarding Faculty-specific deadlines and submission processes.

Principal Investigators: Complete a Research Management System (RMS) record, including a copy of your complete application, and submit this for approvals in RMS.

Postdocs, students, and trainees: For fellowships and externally-sponsored research training awards or opportunities, you must complete the Research Funding Application Approval (RFAA) Trainee PDF form, and submit it, along with a complete copy of the application, to Research Services at rsotrainee@ucalgary.ca. Trainees should not use RMS at this time.

Approvals: The University of Calgary requires that all funding applications be approved prior to submission. Approval requires signatures via either RMS or the RFAA Trainee form, in the following order:

• Principal Investigator
• Department Head
• Faculty ADR/Dean
• Research Services (on behalf of the Vice-President Research)

Read the Meaning of Grant Signatures policy to understand what your approval means. Please see the agency guidelines for details about which signatures are required on your application, as it may differ from internal requirements.

Late submissions: Late submissions will only be accepted in cases of medical or family emergencies, or other exceptional circumstances. If you submit your RMS record to Research Services after the internal deadline has passed, you must secure additional approvals. Please read: Late Applications Process.

RESOURCES

Reminder: The sooner the researcher engages with Research Services, the more help we can be!

Contact the following Research Service units for support with:

Projects Involving Indigenous Research:

Support with incorporating wise practices in Indigenous research, community engagement, and Indigenous data management is available through the Indigenous Research Support Team (IRST).

Applicants can reach out by email to IRST at IRST@ucalgary.ca in advance of the RSO internal deadline. For more information about IRST, please visit the IRST webpage.

Knowledge Mobilization, Research Impact Assessment, DORA:

Support for knowledge mobilization/engagement/translation, community partnerships, research impact, responsible research assessment (DORA), and open science, is available through the Knowledge to Impact team.

Applicants can reach out by email to the KI team at knowledge.impact@ucalgary.ca.

For more information and access to resource archives, please visit the KI team webpage.

Research Data Management:

For information on research data management plans, processes, or best practices for your research program, please contact research.data@ucalgary.ca.

EDI in Research:

RSO can provide resources and support to research teams on the integration of equitable and inclusive practices in research design and research practice.

Contact edi.rso@ucalgary.ca for more information.

Research Security:

The Research Security Division is available to ensure researchers adhere to research security guidelines and policies, including the National Security Guidelines for Research Partnerships (NSGRP) and the policy on Sensitive Technology Research and Affiliations of Concern (STRAC).

Visit the Research Security website to learn more or contact researchsecurity@ucalgary.ca.

Pre-Award Submissions:

RMS: Creating a Pre-Award LOI