Accelerating Clinical Trials: Canadian Biotechnologies

Eligibility

Applicant/Trial Eligibility 

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.

The nominated principal investigator(s) can only submit one application to this competition.

The trial must evaluate a biotechnology and the biotechnology company partner must be Canadian-controlled.

Eligible applicants must be endorsed by one of the 28 ACT Networks.

• Each Network can endorse a maximum of three applications to this competition, and each application is restricted to a single RCT.

Eligible applicants must agree to transfer funds to an organization eligible to hold CIHR funding; this organization will report the use of funds according to CIHR-eligible expenses. Investigators must provide confirmation from their institution that the proposed budget is CIHR eligible.

The applicant will be expected to acknowledge ACT Consortium partnership and funding in all related presentations and publications.

• 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. Applicants also commit to making their trial results publicly available (open-access publication). The proposal is an RCT and not a product validation observational study.

*Please note that each proposal that meets eligibility for review will receive a mark out of 100, and all ineligible applications will not receive a grade. 

Summary

The Accelerating Clinical Trials (ACT) Canada Consortium was established to accelerate, optimize, and facilitate the conduct, implementation, and results translation from high-quality, high-impact randomized controlled trials to improve health in Canada and around the world.

ACT brings together hundreds of researchers from 28 networks, 11 trial units, patient-partners, the biotechnology industry, government, and experts in research ethics review processes, contracts, insurance, regulatory processes, patient engagement, clinical trials training, communications, knowledge mobilization - from Nova Scotia to British Columbia and Nunavut.

Objective:

Given that most biotechnologies require randomized controlled trials (RCT) demonstrating efficacy and safety to obtain regulatory approvals, the objective of this request for applications (RFA) is to fund trials evaluating products from Canadian-controlled biotechnology companies in partnership with ACT Network clinical trialists. Through this RFA, ACT aims to provide foundational support to Canada’s Biomanufacturing and Life Sciences Strategy (BLSS) by enabling Canada’s best researchers and companies to undertake the clinical trials efficiently, aligned with BLSS, Pillar 3: Growing Businesses by Doubling Down on Existing and Emerging Areas of Strength; the goal being to improve the health of Canadians

Proposal Sections

Applicants submit their maximum 7-page pdf proposal in English, or maximum 8-page pdf proposal French. For more in-depth information regarding the structure of acceptable proposals, please reference the outline here. 

Application Instructions

Applicants submit their maximum 7-page pdf proposal in English, or maximum 8-page pdf proposal French. Please combine all application components into a single PDF file.

• The written proposal must be a maximum of five (5) pages if written in English, or six (6) pages if written in French. The page count is inclusive of a one (1) page trial summary.
• Budget and justifications are required up to one (1) page.
• References, figures, or tables are optional up to one (1) page. 

To submit the full application PDF, please send all completed documentation to act-aec@phri.ca by 12 pm Friday, July 7, 2023 (EST), or 10 am (MT).

Resources

CIHR Policies Regarding Trial Reporting

Full RFA Outline

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.

Submission Instructions:

1. Complete Full Application as instructed by ACT.
2. To initiate internal approvals, complete the Pre-Award/Application record in RMS (https://research.ucalgary.ca/conduct-research/additional-resources/resea...), attach the pdf version of your completed Application as well as any required supplementary documents, and submit for approvals from your department head and/or faculty Associate Dean (Research). *Important: when submitting in RMS, please ensure that you allow time for academic approvals prior to the Research Services review deadline of 12:00pm on July 4, 2023
3. Once these approvals are obtained, RMS will automatically forward the Application record to Research Services for institutional review and approval.
4. Research Services will review, provide feedback (by email) if necessary, and will provide the institutional approval. If digital or wet-ink signatures are required, we will provide the capping institutional signature and will advise when ready.
5. Full Applications, including any supplementary documentation, should be submitted by email to act-aec@phri.ca  on July 7, 2023 by 10:00 AM Mountain Time

Adjudication Process

ACT personnel will review each application for eligibility. ACT will not further consider any ineligible application based on the information provided.

Feedback to Applicants

We will provide the principal applicant of each eligible application information on the number of eligible applications submitted to this RFA, the number awarded, and whether they were successful. We will provide brief written comments from reviewers back to applicants, along with each reviewer’s score.