ict Multi-Year Grants Funding Opportunity

ict Multi-Year Grants Funding Opportunity

Overview Background Strategy for Patient- Oriented Research (SPOR) Innovative Clinical Trials initiative (ict) SPOR and JDRF Partnership on Innovative Clinical Trial Multi-Year Grant Specific Objectives Funds Available Research Focus Areas Eligibility Application Requirements Relevance Review Peer Review Evaluation Criteria Application Process Timeline 2

Background This funding opportunity reflects the partnership between CIHR and JDRF to support clinical trials research for type 1 diabetes. JDRF s mission is to accelerate life-changing breakthroughs to cure, prevent and treat type 1 diabetes and its complications. CIHR s mandate is to excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products and a strengthened Canadian health care system. 3

Strategy for Patient-Oriented Research (SPOR) Objective Foster evidence-informed health care by bringing innovative diagnostic and therapeutic approaches to the point of care, so as to ensure greater quality, accountability, and accessibility of care. Ensuring that the right patient receives the right intervention at the right time. 4

Patient-oriented Research A continuum of research that engages patients as partners, focusses on patient-identified priorities and improves patient outcomes. This research, conducted by multidisciplinary teams in partnership with relevant stakeholders, aims to apply the knowledge generated to improve healthcare systems and practices. 5

Innovative Clinical Trials (ict) Innovative clinical trials (ict) use designs that are alternative to traditional Randomized Controlled Trials. ict designs have application in areas ranging from product development to health system improvement. ict methods can reduce the cost of conducting trials, reduce the amount of time needed to answer research questions, and increase the relevance of research findings to patients, health care providers and policy makers. Adopting these alternative designs can maximize the use of existing knowledge and data. 6

SPOR ict Initiative Aims to increase Canadian competitiveness in ict research and provide a stimulus for trialists to adopt new methodologies. Funding allocated through the ict initiative will adhere to the principles that underlie all SPOR programs. These principles include a focus on improving patient outcomes and health systems, meaningful engagement of patients and other stakeholders; and an emphasis on outcomes. 7

Focus of the SPOR ict Initiative Comparative effectiveness research of diagnostics and treatment modalities (drugs and interventions) in use in Canada. Comparative effectiveness research compares two or more healthcare options already shown to be efficacious. Implementation research, particularly in areas where research investment can be expected to directly impact patient experience and care. Implementation science research examines interventions that have already been shown to work under certain conditions within certain contexts, to determine if they can be adapted to work under other conditions and in other contexts. 8

Specific Objectives Enable new and established investigators to undertake innovative clinical trials in the area of type 1 diabetes (T1D); Support the development and testing of innovative paradigms for clinical studies in adult and pediatric T1D; and Build capacity for ict research through training and mentoring. 9

Funds Available The total amount available for this competition is $12M, enough to fund up to 4 grants. The maximum amount is $750K per year for up to 4 years, for a total of $3M per grant. CIHR and JDRF will each contribute a maximum of $375K per year for up to 4 years. Conditions of funding: Successful grantees must enter into agreements with JDRF. CIHR and JDRF will co-fund each grant at a ratio of 1:1. The applicant is therefore not required to find a match. 10

Research Focus Areas METABOLIC CONTROL Funding Pool 1 - Minimum of 1 grant Research to evaluate or implement use of new approaches to improve glycemic control and regain metabolic homeostasis while reducing disease burden. ARTIFICIAL PANCREAS & DEVICES Research to evaluate or implement the use of new technologies to enhance glycemic control; including coupling technology to insulin delivery and controller algorithms to automatically regulate blood glucose levels. 11

Research Focus Areas Funding Pool 2 - Minimum of 1 grant BETA CELL REGENERATION & SURVIVAL Research to evaluate or implement use of therapies that preserve or restore beta cell mass and function in T1D through reduction in beta cell stress; promoting beta cell survival, or through expansion of existing beta cells or formation of new beta cells. IMMUNOTHERAPIES Research to evaluate or implement use of immunotherapy approaches for T1D including vaccines or drugs that restore durable beta cellspecific immune tolerance with the aim of preventing disease progression in people at risk; or in the earliest stages of T1D and preserve residual and regenerated beta cells after T1D onset. 12

Eligibility The Nominated Principal Applicant must be an independent researcher affiliated with a CIHR eligible institution. There must be at least five Principal Applicants and/or Principal Knowledge Users ensuring coverage of all of the following categories (the NPA can count as one of these applicants): Two researchers (this must include at least one new investigator); Health care professionals; Policy makers who have the ability to influence health policy or the delivery of health services; and Patients. 13

Application Requirements The proposed research activities must be patient-oriented research. The proposed research must be an innovative clinical trial. Applicants must focus on comparative effectiveness research; and/or implementation science research. Applicants are required to work with the SPOR SUPPORT Units in building their applications. Successful applicants are expected to engage with other SPORfunded entities such as Diabetes Action Canada and Listening, Learning, Leading: Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease. 14

SPOR SUPPORT Units SPOR SUPPORT Units* may be able to provide services in the following areas: a) Patient Engagement b) Data Platforms & Services c) Methods Support & Development d) Health Systems, KT & Implementation e) Real World Clinical Trials f) Career Development in Methods & HSR g) Consultation & Research Services *For SPOR SUPPORT Units contact information, please see Additional Information section of the Funding Opportunity. 15

SPOR Network in Diabetes and its related complications Diabetes Action Canada is able to partner by offering the following resources: Innovative clinical trial design Implementation science and comparative effectiveness research expertise Patient engagement resources A network of T1D clinical trial researchers Sex-Gender integration into your proposal Health economics analytic capability Knowledge translation and scale up expertise Policy-makers with interest in diabetes Contact: info@diabetesaction.ca 16

Canadians Seeking Solutions & Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD) Opportunities for collaboration and partnership: Patient engagement methodology and best practice Priority setting with patients Respectful engagement of Indigenous partners Knowledge translation and dissemination Biobanks linked with clinical data (under development) National registry of patients interested in clinical trials (under development) Clinical trials network for nephrology research Linkage to large international T1D study (AdDIT) More info: www.cansolveckd.ca Contact: info@cansolveckd.ca 17

Relevance Review CIHR and JDRF will provide funding for applications that address the objectives, research areas and application requirements as described in this funding opportunity. A comprehensive relevance review will be conducted through the Letter of Intent phase in collaboration with JDRF, CIHR and a subset of the review committee. Applications that are not deemed to be relevant will be withdrawn from the competition. 18

Peer review The peer review committee will be created specifically for this funding opportunity. Members will include, but are not limited to, patients, patient engagement experts, researchers, health professionals and policy makers. For further information on CIHR s peer review principles, see Peer Review: Overview section of CIHR s website. 19

Evaluation Criteria To support the strategic objectives of this funding opportunity, the *following factors will be considered: Potential Impact Scientific Merit Research team Engagement and Partnership Performance Measurement Plan Budget Mentoring and Training *Please review the funding opportunity for the detailed evaluation criteria 20

Application Process Please read all instructions in THE FUNDING OPPORTUNITY to familiarize yourself with the application process before applying. An overview of CIHR s application processes can be found under Application Process. The application process for these funding opportunities is comprised of two steps: Letter of Intent & Full Application. To complete your Application, follow the instructions in the Grants - ResearchNet "Application" Phase Instructions along with any additional instructions found under Specific Instructions. Reminder to applicants: Please ensure that your application is complete (includes all required signatures) and is submitted on time to CIHR. 21

Timeline Submission Anticipated Notice of Decision Funding Start Date Letter of Intent August 8, 2017 August 29, 2017 n/a Full Application November 14, 2017 March 29, 2018 April 1, 2018 22

For more information Please review the full funding opportunity available on the CIHR Funding Opportunity Database (accessible through the CIHR website and/or ResearchNet). For inquiries please contact: CIHR Contact Center Telephone: 613-954-1968 Toll Free: 1-888-603-4178 Email: support@cihr-irsc.gc.ca JDRF Administrative Questions: Jami Goodman International Partnerships Administrator Email: jgoodman@jdrf.org Telephone: 1-212-479-7603 JDRF Scientific Questions: Dr. Bob Goldstein Chief Scientific Officer Email: gold@jdrf.ca Telephone: 301-651-1898 23