CRI Clinical Innovator Apply for a Clinical Innovator Grant CRI Grants Portal Innovative immunotherapy clinical trials proposed by academic researchers are vitally important to improving patient outcomes. The CRI 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. 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 iATLAS platform. 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. 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. 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. Instructions for Applying 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. Supporting Materials The Initial Protocol Concept must include: A brief protocol concept (maximum 2 pages, excluding study schema and references) including;a. Study rationaleb. Primary objectives c. Secondary objectivesd. Number of patients to be treatede. Patient eligibility criteriaf. Sample collection plang. Biostatistics plan A separate one-page study schema should be uploaded outlining the clinical design. A brief translational plan (maximum 1 page, excluding references)a. Translational aims and rationale b. Assays intended to use and samples to be tested Biographical sketches for PI(s) and co-PI(s) (limit bibliography to past 5 years or publications relevant to proposed study) Notes: Only PDF documents will be accepted. All files must be submitted individually on the attachments page of the online application. When you have finished uploading the attachments, click “Submit.” You will receive a notice confirming that you have successfully submitted your Application Form. Immediately after, an automated notification from CRI will be sent to your email address, also confirming submission. If you encounter problems uploading your attachments, email them to [email protected]. Be sure to note the application number, which will be assigned to you at the time of submission. Online applications will be accepted until 5 p.m. Eastern Time on the deadline date. If the deadline falls on the weekend, applications will be accepted until the close of business that following Monday. We strongly suggest submitting your applications as early as possible to provide ample time in case your application is incomplete. Incomplete applications will not be considered. Formatting Guidelines: Any documents you attach to your online application form must be typed single-space using a 12 point or larger font size. 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 PROTOCOL CONCEPT December 1 INVITED FULL PROPOSAL May 1 (If a deadline falls on the weekend, applications are due the following Monday.) Application Resources Invention Disclosure Form Annual Invention Update Form Standard Revenue Sharing Agreement Terms and Conditions