2015 Request for Applications Clinical Research Services Pilot Funding Program

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1 2015 Request for Applications Clinical Research Services Pilot Funding Program An opportunity for full-time faculty to obtain support for the planning and successful implementation of clinical interventional pilot studies AWARD DESCRIPTION & CRITERIA The University of Minnesota (UMN) Clinical and Translational Science Institute (CTSI) announces the Clinical Research Services Pilot Funding Program to support the successful planning and implementation of clinical interventional pilot studies. For the purposes of this funding program, a clinical interventional pilot study is a small study conducted to provide information about the intervention, the outcome, or recruitment necessary to complete design of a clinical trial. Examples include, but are not limited to: A study to determine the appropriate study population, intervention or outcome Collection of information necessary to estimate sample size, effect size, attrition rate or response rate A study to refine the intervention Testing the feasibility of an outcome or intervention in the field Determining whether adequate adherence to a treatment is achievable The goal of this program is to provide support for UMN investigators to plan and pilot an interventional clinical protocol for a focused clinical research question. It is expected that the pilot study data gathered through this funding mechanism will be sufficient to inform the study design of a larger clinical trial. Projects must be for interventional clinical research and will be evaluated on likelihood of success as a pilot study. All funded projects will be required to establish milestones, and milestone progression will be monitored in collaboration with a CTSI Research Project Manager. All UMN full-time faculty may apply for the funds. PROJECT FUNDING This is a two-stage funding program. Stage 1 funding: The goal of Stage 1 is the development of a detailed project plan (protocol, budget, timeline, etc.) for the proposed interventional pilot study. Stage 1 is designed to support the costs of staff time during the project planning stage and provide assistance with planning and design of the pilot study. Overall operational feasibility of the project will be assessed by CTSI staff in collaboration with the grantee during this Page 1 of 5

2 planning period. CTSI will provide planning support at no cost. In addition, up to $5,000 will be available to the grantee s study team during this period. It is anticipated that this planning period will be completed within 6 months. Stage 1 projects successfully completing the planning process are eligible to be considered for Stage 2 funding. Stage 2 funding: The goal of Stage 2 is the successful implementation and completion of the interventional pilot study, for the purpose of obtaining preliminary data needed to inform the larger clinical trial and provide information to support applying for future funding. CTSI will provide project management support at no cost during the implementation stage. In addition, funding of $25,000-75,000 will be milestone-based and the project expected to be completed within 18 months. PROGRAM MODEL AWARD DESCRIPTION CTSI anticipates funding up to five Stage 1 awards in It is expected that only a subset of these projects will be funded in Stage 2. Page 2 of 5

3 STAGE 1 ELIGIBILITY 1. Applicant/PI must be a full-time faculty member in the University with the following appointments: N (Probationary, Tenure Track Faculty), P (Indefinite Tenure, Faculty), I (Clinical Scholar, Medical School), J (Multiple Year Contract), K (Annual Renewable Contract), and employment through any University of Minnesota campus. 2. Proposed project must be to conduct a pilot clinical trial as defined by NIH A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions. 3. Project must meet the definition of Pilot study: a clinical interventional pilot study is a small study conducted to provide information about the intervention, the outcome, or recruitment necessary to complete design of a clinical trial. Applicants are strongly encouraged to view the presentation on statistical guidelines for pilot studies by following the link below before applying to this program: STAGE 1 APPLICATION PROCESS STAGE 1 PRE-APPLICATION A mandatory Letter of Intent (LOI) is due on March 16, 2015 (5:00 PM CDT). The components of the LOI will include: 1. Project title 2. PI and co-investigators 3. Long-term goals of project (250 word ) 4. Specific aim(s) of the interventional pilot clinical research study 5. Brief description of proposed interventional pilot study (250 word ) Please submit your LOI through the following submission link by March 16, 2015 (5:00 PM CDT): CTSI Pilot LOI Submission Form. Additional information can be found on the CTSI website: z.umn.edu/ctsifunding. NOTE: You may save and return to complete your submission at any time using the code provided when the Save and Return Later option is selected. To return to the form re-click the link identified above. Letters of intent will be reviewed to confirm eligibility of the applicant, ensure that the project scope is appropriate as an interventional pilot study, and enable the identification of reviewers with applicable expertise. Invitations to submit full proposals will be issued within approximately one month following receipt of LOIs. Please contact Karen Cook at or Stacy Valenzuela at with any questions regarding the CTSI Pilot Grant program. Page 3 of 5

4 STAGE 1 FULL PROPOSAL SUBMISSION (by invitation) The deadline for submission of the full proposal is May 4, 2015 (5:00 PM CDT). The link to the full proposal submission form will be provided to those applicants invited to submit full proposals. Application Components: 1. Applicant Information 2. Overall Research Summary: (Arial 11 pt font), ½ inch margins, single spaced proposal, to include: a. Project Title b. Brief description and objectives of larger clinical trial Provide a clear and concise description of your overall research goal and objective, for which you would like this pilot project to provide supporting data. c. Significance of project Describe the nature of your project and the potential significance and impact of the proposed research. Provide supporting evidence for the project objectives. 3. Pilot Study Description a. Protocol concept i. Study intervention ii. Study arms (if applicable) iii. Study procedures iv. Location of study procedures v. Safety considerations (if applicable) b. Budget summary to cover department personnel (e.g., coordinator, lab tech) during the planning stage (up to $5000). Note: This program does not cover salaries of faculty. It is anticipated that planning may require up to 4 hours per week. c. Study personnel qualifications: Outline the study team members and each role. Briefly describe the experience and qualifications to make the role well suited for the proposed project. i. For any listed investigators (PI and/or Co- Investigators), provide NIH Biosketch of Principal Investigator(s), Co-Principal Investigator(s) and Co- Investigator(s) d. References (not included in the 3 page Research Strategy limit) 1 page 2 pages.5 page.5 page 4 page per investigator REVIEW AND AWARD CYCLE LOI due March 16, 2015 (5:00 PM) Full Proposals due May 4, 2015 (5:00 PM) Awards Announced June 2015 Earliest Stage 1 Award Start July 1, 2015 Page 4 of 5

5 REVIEW CONSIDERATIONS Proposals will be evaluated based on the following criteria: Does the project address an important clinical problem? Is the overall strategy well-reasoned and appropriate to accomplish the goals of the project? Does the scope of the plan support the probability of successful completion of the pilot study? Do the PI and/or investigative team have the necessary expertise to conduct the proposed work? AWARD NOTIFICATION After the committee completes its review, all applicants will be notified of their funding status and provided with reviewer comments. Proposals receiving the highest scores will be awarded funding through Stage 1. Applicants selected for funding will be strongly encouraged to make appropriate revisions to their experimental plans that reflect feedback from the review committee. Projects successfully completing the planning stage will be eligible to be considered for Stage 2 funding. The funds for the award will be available through an account within CTSI and awardees will be granted access to these funds after the terms of agreement are signed. Funding will be provided with the understanding and expectation that these funds will be spent on services outlined in the application budget. FUNDING PERIOD EXPECTATIONS Funded projects are expected to have Stage 1 project plan development completed within 6 months of award date. Stage 2 study implementation is to be completed by the 18-month period from the Stage 2 grant award date. Grantees will agree to periodic meetings with the CTSI Clinical Project Manager following initiation of the award. The project manager will continue to work with the PI throughout the study duration of the award to monitor progress on the project and disbursement of funds. Midcourse corrections may be needed to address unexpected logistical barriers, or other project design modifications may be required. If the review committee finds that grantees are not making significant progress, the unspent funds will be forfeited. No cost extensions will not be allowed. PROGRAM CONTACT INFORMATION Karen A. Cook Manager, Project Management and Regulatory Clinical and Translational Science Institute Phone: Page 5 of 5

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