Participation in phase I oncology trials by minorities: Survival and compliance data

e18628 Background: Since 1993, the National Institutes of Health requires all clinical trials to include women and minority participation in clinical research. Despite this initiative, Minority (M) participation in Phase I Oncology clinical trials is subpar; historical data indicate a participation of 79% Caucasian (C) versus 21% (M) in Phase I clinical trials. The purpose of this study is to compare demographics, survival, and compliance data between (C) versus (M) patients participating in Phase I Oncology clinical trials in our Cancer Institute. Methods: We performed a retrospective analysis in all patients enrolled in phase I clinical trials in our institution from April 2019 until October 2022. This information was obtained via OnCore. Data was abstracted manually and entered in a spreadsheet (Excel). Data variables include race, gender, withdrawal of consent, and lost follow-up. Statistical plan was determined by our statistical team with data analysis to be performed with statistical software to generate Kaplan Meyer (KM) Survival Curve. Results: A total of 99 patients were identified. 61.5% were (C) and 38.4 % were (M). (M) consisted of Hispanic (81%), African American (18%) and Asian (1%). Female Gender on (C) were 57.4% and 55.3% on (M). Lost follow-up was 2.8% on (C) and 5.9% on (M). Withdrawal of consent was 5.6% on (C) and 0% on M. The (KM) curve revealed non statistically significant difference in survival p = 0.7316. Conclusions: In our analysis, we found statistically similar (KM) survival curves for (C) and (M) participating in Phase I clinical trials (p = 0.7316). We found a significant higher participation of (M) patients in our institute than historical data. There was no significant difference in withdrawal of consent between (C) and (M) and no difference on lost follow-up. We plan to identify patterns of success in enrolling minorities in our site and validate a questionnaire to screen patients for Phase I clinical trials with the goal to minimize perception bias and barriers for enrollment of (M) in Phase I studies.