N. Solomon, E. Taborda, I. J. Choi, A. M. Chhabra, C. B. Simone II, and S. Hasan; New York Proton Center, New York, NY
Purpose/Objective(s): Per the Commission on Cancer, overall enrollment in clinical trials is only 20% at NCI-designated centers and only 6.3% overall, with minorities largely underrepresented. We hypothesize disparities in accrual can be reduced with institutional initiatives to achieve uniform enrollment of patients in clinical trials. Materials/
Methods: At our institution, research coordinators consult with every patient before treatment to discuss enrollment in a treatment intention or registry trial. We explored the demographic composition of those who did and did not enroll and compared the two groups via chi-square analysis. Results: Between September 2019 to December 2023, 3,755 consecutive patients were treated, all of whom were offered enrollment onto our clinical prospective registry and/or treatment-intention trials. In total, 95.5% (3,588) enrolled and 4.5% (167) declined. Of those enrolled, 59%, 12%, 10%, 8%, and 11% were White, Black, Asian, Other, and not reported/disclosed, respectively. Of the non-enrolled patients, 34%, 15%, 11%, 10%, and 30% were White, Black, Asian, Other, and not reported, respectively. The rate of decline was 2.6%, 5.4%, 4.8%, and 5.6% of White, Black, Asian, and Other, respectively. White patients were more likely to consent to research than all other groups including Asian (OR = 1.8817, 95% Cl = 1.106 to 3.199, P = 0.019), Black (OR = 2.137, 95% Cl = 1.320-3.458, P = 0.002), and Other (OR = 2.321, 95% Cl = 1.330-4.049, P = 0.003). There was no difference in enrollment between Hispanic and non-Hispanic patients (OR=0.699 95% Cl = 0.445 to 1.092, P = 0.119). The average age for enrolled and non-enrolled patients was 52 (IQR = 31) and 51 (IQR = 33), respectively. Largest disease sites for enrolled patients included head and neck (28.6%), breast (10.6%), CNS (9.8%), prostate (8.4%) and lung (8.3%). When offered, 1.7% of head and neck, 0.71% of CNS, 0.26% of breast, 0.37% of lung, and 0.37% of prostate patients did not enroll. Breast cancer patients were more likely to enroll than for CNS, head and neck, lung, and prostate cancers (OR = 2.303, 95% Cl = 1.196 -4.431, P = 0.012). There was no significant difference of enrollment between patients being treated for CNS, head and neck, lung, and prostate cancers. Of the non-enrolled group, 54% were male and 46% were female. Among the patients who did not enroll, 68% had public insurance, 30% private and 2% were self-paying. Those declining enrollment did so due to lack of interest in research (48%), otherwise unknown reasons (40%), communication barriers (7%), and privacy concerns (5%). Conclusion: This study demonstrates that much higher rates of clinical trial enrollment is possible than what has historically been reported, and that minority underrepresentation can be mitigated when overall enrollment is institutionally prioritized. However, minorities still declined enrollment at a higher rate than White patients, and further investigation is needed to explore reasons and means to further reduce disparities.
