Site research infrastructure and institutional performance: A report from the Voting Body of the Children’s Oncology Group (COG).

Abstract

e23113 Background: National Cancer Institute (NCI) sponsored cooperative group clinical research has led to significant improvements in outcomes for childhood cancer in the United States. COG is the world’s largest cooperative group, comprised of 218 institutions in good standing. There are no benchmark data of the necessary research infrastructure for successful participation in COG research. Objectives: 1) To ascertain the research personnel (RP) devoted to COG research at each member institution. 2) To compare available resources with institutional performance. Design. Methods: A REDCap® survey was designed and sent to all 218 COG institutional principal investigators (PI) with a 4-week window to complete the survey with scheduled reminders. Questions included number of and types of RP [clinical research associates (CRA), nurses, and regulatory]. To measure performance, we used the 2022 Institutional Report Card from COG that reports open trials and enrollments at each site. Sites were categorized into 4 groups based on self-reported new oncology patients diagnosed per year. We compared the number of RP to the a) number of studies open, b) enrollment on therapeutic and non-therapeutic studies. We ranked performance into quartiles by institution size. Results: 134 PIs (61%) answered some or all questions on the survey. All institutional sizes were well-represented. Total number of RP varied dramatically, even among institutions of similar size, with median number 3 RP, range 0.9-28.5. Comparing the number of open studies to regulatory personnel at site, those institutions in the top quartile for each group (except very smallest) had a minimum of 91 studies open and had at least 1 FTE for regulatory, while those in the lowest quartiles (10-67 studies open) had < 1 FTE. Total number of RP were similarly correlated with the number of enrollments, with mean of 12.5 and median 15 enrollments for each RP. Conclusions: Sites successful at opening COG studies and enrolling patients had more research personnel. We show to perform in the top quartiles, there should be at least 1 FTE dedicated to regulatory issues and another 1 FTE for every 12-15 enrolled subjects. [Table: see text]