CTSI-Funded Pilot Programs: Function, Operation and Outcomes Susan Autry, University of Southern California Mike Conlon, University of Florida

Pilot Program Goals Investments to help meet overall CTSI goals: $s to help start new research ideas or advance to next step Young investigator investment RFPs to foster specific outcomes/behaviors

USC RFP categories, eligibility, size

UCSF Pilot Funding RFPs Pilot Research Award for Junior Investigators Pilot Research Awards for Junior Investigators Utilizing CTSI Clinical Research Services (CTSI-CRS) General Pilot Award Program in HIV/AIDS Pilot Research Awards in Research Policy Mobile Health Research Novel Clinical/Translational Methods Catalyst Awards New Direction Awards Post Childbearing Professional Development Leave Shared Instrument Awards Multi-center Start-Up Planning Awards Multidisciplinary Research Project Planning Award Under-represented Faculty in Clinical and Translational Research Awards

Openly Developed Proposals

UF RFP categories, eligibility, size CategoryEligibilityMaximum Award TraineeDegree seeking MS, MPH, MD, PhD w/ mentor $7,500 Jr. InvestigatorTenure track w/ mentor$20,000 Novel Methods and Technologies All faculty and mentored trainees$25,000 Major Initiative (discontinued) $100,000 Applications must demonstrate alignment with CTSI strategic goals For 2012, the UF RFP emphasized use of the CTSI core laboratories and/or collaboration with the CTSI Communications Research Program Previous RFPs have emphasized the data warehouse and community engagement

Application Preparation Publicity of the opportunities Timeline Letters of Intent [do you use them and how] Proposal length and format Review criteria Limit number of proposals by one investigator in a cycle or RFP? Mentor notification required?

Review Committees Review process – transparency critical – Triage to committee – In person discussion vs asynchronous review Composition of committees Managing COI Scoring – process and how used Funding decisions – not by score alone Feedback to investigator

Award Requirements Notification – pre-award letter – Award letter – lays out requirements Required documents – IRB / IACUC approvals etc Budget restrictions – Faculty salary – subawards Budget period Carry over

Post Award Management Who is responsible How is project progress tracked – Financial vs progress/outcome Frequency Metrics ROI

Pilot Program Management Funds available per year Number of cycles per year Staffing to manage – FTE and types Review committees – Number and composition – Staffing support Involvement/coordination with other intramural funding programs

IT systems used Integrated/comprehensive or by function: Proposal Submission Triage to committee chairs Submitting scores and comments Feedback to investigators

Impact of the Pilot Program Short term and long term – Varies with type of RFP Investigators viewpoint Research programs created Collaborations created Presentations and papers External funding

Challenges Developing well articulated RFPs that enable you to meet goals Trainees and junior investigators Avoiding conflict of interests in reviews Budget periods/ carry over Changing the culture

UCSF Pilot Funding Program ( ) Invested $1 million annually 608 applications submitted, 118 awarded funding Awards have resulted in 89 presentations, 50 publications 77 submissions for extramural funding resulting in $7.02 million in new funding. Web-based application and review process was so efficient, other major campus pilot-funding agencies engaged with CTSI to create the UCSF Research Allocation Program (RAP) and now provides about $3.4M in annual pilot funds.

USC Pilot Funding ROI 90 Presentations 30 publications

Florida Pilot Program Examples Program has funded 31 of 89 proposals over 3 years for a total of $906K. A 2009 pilot award of $50K for ethanol monitoring to Dr. Sara Jo Nixon led to a $1.8M grant to a team including Dr. Nixon. A 2010 pilot award of $20K to Dr. Michael Weiss established a 7 hospital consortium for brain cooling of neonates with Hypoxic Ischemic encephalopathy (HIE) that has treated 40 infants, prevented life-long disability for 5 and reduced care costs by $12M