225 Evaluation of the characteristics and impact of the NCATS CTSA Program pilot translational and clinical studies

Objectives/Goals: To fully understand the scientific objectives, overall financial commitment, and outcome of the pilot projects. Methods/Study Population: We evaluated pilots reported in the in the annual, interim, and final Research Performance Progress Reports (RPPRs) for Clinical and Translational Science Awards (CTSA) Program UM1 and UL1 grants from FYs 2021–2023 to assess research categories across the translational science spectrum. We analyzed the number of pilots involving human subjects, vertebrate animals, both, or neither; financial allocations; publication outputs; and other characteristics. Pilots reported across multiple years were deduplicated and assigned to the latest reporting year. Each pilot was classified into broad (Category 1) and specific (Category 2) areas. Descriptive statistics, including means and frequency distributions, were generated. Multi-year pilots with NA or 0 values used the most recent prior value. Results/Anticipated Results: In the period from FY 2021 to 2023, 61 hubs reported 1,811 unique pilot projects in their RPPRs, receiving a total of approximately $62 million, of which two-thirds were expended. On average, each hub conducted 30 pilots with an award size of about $35K. Just over half of the pilots involved human subjects research (HSR), while about one-third were neither HSR nor vertebrate animal studies (VAS), with the remaining focused primarily on VAS. Notably, only 13% of pilots resulted in peer-reviewed publications. Collaborative efforts were observed in one-third of the projects. The majority of pilots fell into Preclinical Research (46%), followed by Clinical Research (33%) and Public Health (20%). Limitations in data quality were identified, and ten pilots reported $0 awarded funds, which may be captured in future RPPRs. Discussion/Significance of Impact: Analysis of pilots reported in RPPRs from FYs 2021–2023 across 61 hubs shows a strong focus on HSR, highlighting collaborative efforts that enhance translational science and align with CTSA goals. Future analysis will help assess the pilots’ impact and their alignment with NCATS’ mission to expedite research translation into health solutions.