Characterization of cancer clinical trials in the community setting.

e13506 Background: Extending clinical trials to community oncology sites is an imperative to meet accrual goals, ensure generalizable results, and facilitate optimal and equitable clinical care. The types of trials attractive to and successful in the community, however, are likely different from those run primarily at academic centers. We analyzed the characteristics of clinical trials open at a network of community oncology practices across the United States in the last 2 years, in order to inform both sponsors and sites about the studies most well-suited for a community setting. Methods: We analyzed characteristics from every clinical trial entered in OncoTrials, a clinical trial screening and tracking tool utilized exclusively by US community oncology practices, between 9/1/2021 through 10/09/2023 via knowledge of the trial NCT number and data available through API from clinicaltrials.gov. Descriptive statistics, including median and range for continuous variables and percentages for categorical variables are reported. Results: 1,310 clinical trials were open across 64 community oncology practices. Sponsors were classified as 80% industry (n=1,054), 15% NIH (n=195), 1% network (n=13) and 5% other (n=48). 93% of studies were interventional, 5% observational, 1% registry and 1% expanded access. Types of interventional studies (n=1,215) and the number of sites that ran them are shown (Table). The median target enrollment across all studies was 235 patients. Individual trials were open at a median of 2 community practices in our cohort (range 1-22 practices); 521 clinical trials (40%) were open at only one practice and 34 trials (2.6%) were open at more than 10 practices. The mean number of unique trials open at a practice during our 2 year observation period was 54 (median 35, range 1-264). Among these trials, the most commonly associated tumor types were lung (15%), pan-solid tumors (14%), breast (11%), lymphoma (6%), colorectal (6%), prostate (5%), gynecologic (4%), bladder (4%), head and neck (4%) and melanoma (4%). Conclusions: Community oncology practices supported a robust portfolio of clinical trials, most commonly focused on treatment of solid tumors. The vast majority were interventional (phase 2-3) and industry-sponsored. Half of sites ran Phase I trials, and Phase IV trials were uncommon but had broad participation across sites. Notably, a large proportion of studies were only open at one single site in a cohort of 64 community oncology practices. This highlights the opportunity for sponsors to leverage networks, consortia, and further research to ensure that appropriate studies are accessible among a broader range of community research sites. Table: see text