Identifying and mitigating racial/ethnic disparities in clinical trials with screening data.

63 Background: ASCO and Association of Community Cancer Centers (ACCC) released a statement on increasing racial/ethnic equity, diversity, and inclusion (EDI) in cancer trials (1). It included recommendations for clinical practices and research sites to 1) screen every patient for trial eligibility; and 2) routinely collect and analyze screening and enrollment data by patient demographic characteristics, including race/ethnicity. Most of the 62 sites that completed a 2021 pilot study reported that screening data were not readily available by patient race/ethnicity (2). ASCO conducted a follow-up study about challenges, resource needs, and effective strategies for collecting and analyzing these data. Methods: Semi-structured interviews were conducted with research team members from sites that completed the 2021 pilot study. Sites were purposefully selected based on pilot study data quality and insights, diversity of patient population, and site type, size, and region. Sites completed a pre-interview questionnaire on site characteristics and screening and enrollment processes before participating in a 1-hour interview focused on challenges and effective strategies for collecting and analyzing screening and enrollment data, by race/ethnicity. Anticipated themes and relationships, stemming from the pilot study findings, informed a conceptual framework. Up to 20 interviews were planned and halted sooner when there was theme saturation. Results: Thirteen research sites participated in the study, representing academic centers (62%) and community-based practices/health systems (38%) with racially/ethnically diverse patient populations (median 31% non-white; range 11% to 63%). 53 research team members participated in the interviews (typically 4 per site), including investigators (23%), directors/managers (56%), and coordinators (21%). Aggregated responses were interpreted through content analysis and concepts were quantified for both frequency and extensiveness. Several barriers to patient screening, data collection, and analysis were cited, including lack of standardized procedures and documentation, dedicated staff and time, quality and/or accessible data on race/ethnicity and/or screening, and integrated technology that facilitates screening and documentation. Conclusions: Collecting and analyzing screening and enrollment data are critical to identifying and mitigating racial/ethnic disparities in trial access and EDI. Many sites do not systematically screen every patient for a trial and/or document outcomes. Lack of resources, including dedicated staff and time and integrated technology, make it difficult for them to do so in systematic and reliable ways. Greater investment in resources will help to facilitate routine screening of every patient and ensure underrepresented populations are not being overlooked for trials. 1. Oyer et al, JCO, 2022 . 2. Pressman et al, JCO, 2022 .