2023 Clinical Innovator

Eligibility

Candidates must be the Principal Investigator (PI) of the proposed study. CRI has no citizenship restrictions, and research supported by the award may be conducted at medical schools or research centers in the United States or abroad. Please note that CRI does not support research at for-profit institutions. 

Summary

Overview

The Clinical Innovator provides funding for clinician-scientists aiming to launch innovative phase I/II or phase II clinical studies using novel immunotherapies. In addition to the merits of the clinical and scientific rationale, studies will be selected based on their novelty, feasibility, and clinical impact. Competitive applications will have a strong focus on yielding mechanistic insights into clinical response and potentials for biomarker discovery and/or validation. CRI will coordinate efforts on selected trials by advising on the following areas: standardizing sample collection, correlative assays, analysis, and data sharing, including, if applicable, deposition of immunogenomic data into the CRI iATLASplatform.

Innovative immunotherapy clinical trials proposed by academic researchers are vitally important to improving patient outcomes. The Clinical Innovator will support novel clinical studies that address areas of high unmet need in cancer and seek mechanistic insights into clinical response with a goal of predictive biomarker discovery. To maximize the impact of each clinical trial, CRI will advise on selected studies in a coordinated effort to optimize clinical trial design and translational studies. 

Financial Information

The Clinical Innovator will provide up to USD $1 million for each clinical trial it supports. The funds may be used for salary, supplies, patient costs, correlative assays, and data analyses. Payment will be structured into milestones to ensure that studies will advance and be brought to completion. 

Award Terms and Conditions

All awardees must adhere to the terms of this award.

Please note: The Cancer Research Institute will not modify the terms of its policies at the request of individual institutions. Policies have been approved by our Board of Trustees, and we do not have the resources to negotiate separately with the many institutions that receive our support.

Application Deadlines

The deadline to submit an Initial Protocol Concept is December 1. Candidates will be notified by late February if they are invited to submit a full proposal, including protocol. Invited applications are due May 1. If these deadlines fall on the weekend, proposals will be accepted until the close of business that following Monday.

Clinical Innovator Application Instructions

An Initial Protocol Concept must be submitted electronically using the CRI online submission portal. If this is the first time you are submitting a grant application to CRI, you will be asked to create a new user account to catalog all applications you submit to CRI.

The Initial Protocol Concept must include:  

1. PDF/Cover Sheet (1 page)
2. A brief protocol concept (maximum 2 pages, excluding study schema and references) including;
   a. Study rationale
   b. Primary objectives 
   c. Secondary objectives
   d. Number of patients to be treated
   e. Patient eligibility criteria
   f. Sample collection plan
   g. Biostatistics plan
3. A separate one-page study schema should be uploaded outlining the clinical design.
4. A brief translational plan (maximum 1 page, excluding references)
   a. Translational aims and rationale 
   b. Assays intended to use and samples to be tested
5. Biographical sketches for PI(s) and co-PI(s) (limit bibliography to past 5 years or publications relevant to proposed study)

Please note that Principal Investigators must also complete a Research Management System (RMS) record, including a copy of your complete application, and submit this for approvals in RMS by the RSO internal deadline

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.