Sixth Call for Proposals: Evaluate Canadian Biotechnologies with Randomized Controlled Trials

Eligibility

For a trial to be eligible, it must fulfill each of the following points: 

1. The nominated principal investigator must be a Canadian researcher who is a member of an ACT Network. Leadership must be in partnership with a biotech company representative. 
2. The nominated principal investigator(s) can only submit one application to this competition.  
3. The trial must evaluate a biotechnology and the biotechnology company partner must be Canadian-controlled. 
4. The proposal is an RCT and not a product validation observational study. 
5. The trial must be endorsed by one of the 34 ACT Networks. 

• Applicants only list one principal ACT Network and each application is restricted to a single RCT.  
• Each Network can endorse a maximum of three applications to this competition. 
• Networks should endorse proposals most relevant to their constituents, especially their patients.  
• No letter of support is required from the supporting ACT Network. 

6. Investigators must provide confirmation from their institution that the proposed budget is CIHR eligible. 
7. Applicants will acknowledge ACT Consortium partnership and funding in all related presentations and publications. 
8. If funded, the applicant must be accountable for their progress, which will be summarized in annual ACT reports. A summary of their project will also be shared within ACT to raise awareness and foster new collaborations.  
9. Applicants commit to making their trial results publicly available (open-access publication). 

Summary

Background:

Canadian biotechnology and clinical trial communities rarely intersect, and consequently few Canadian researchers undertake randomized controlled trials (RCTs) evaluating Canadian biotechnologies.

Few, if any, small- and medium-size biotechnology companies in Canada have the capital to fund the clinical trials required to obtain regulatory approval of their products, and few major pharmaceutical or biotechnology companies have their headquarters in Canada, which limits opportunities for Canadians to lead clinical trials.

Since most biotechnologies require RCTs demonstrating efficacy and safety to obtain regulatory approvals in Canada, the objective of this RFA is to fund trials evaluating products from Canadian-controlled biotechnology companies in partnership with ACT Network clinical trialists.

Applicants can request up to $400,000 (CAN) in funding to facilitate phase 2, pilot, or Vanguard trials.  Trials that assess safety, recruitment potential, and feasibility are also welcome provided they are an RCT.

Overhead

n/a

Application deadlines

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.

Submission Process:

Please see full application instructions from ACT here.

Full application PDF, plus approvals in RMS, will be required by RSO by noon on December 17, 2024. Please be sure to select "Submitted for approvals" (Under Save & Progress) in RMS in enough time to allow for approvals from your Department Head and/or ADR prior to the internal RSO deadline. Consult your department and faculty for more information on their approval processes and timelines.

Do not submit through ACT's application portal until RSO approval has been granted!! 

Once institutional approval has been obtained, submit PDF application through ACT's online portal [https://redcap.link/RFA6SubmissionPortal] no later than 12:00PM Calgary time on January 5, 2025.

RESOURCES 

Support for projects involving Indigenous Research: 

Support with the development of your grant application 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. 

Support for Knowledge Mobilization, Research Impact Assessment, DORA: 

Support for knowledge mobilization/engagement/translation, community partnerships, research impact, responsible research assessment (DORA),  writing a Most Significant Contributions statement for the CV 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, please visit the KI team webpage. 

Support for Research Data Management: 

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

Support for 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. 

Support for 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.  

Reminder: The sooner the researcher engages with RSO units, the more help we can be! 

RMS: Creating a Pre-Award Application