Breaking Barriers for Cancer Clinical Trials: A Multi-Tiered Interventional Approach to Boost Racial and Ethnic Minority Participation in Early-Phase Studies

Newswise — Background:Racial and ethnic minority populations are underrepresented in cancer clinical trials. The USC Norris Comprehensive Cancer Center (USC NCCC) has multiple clinical trial recruitment sites, including the Los Angeles General Medical Center (LAG), the largest safety-net hospital in the western USA. LAG partners with USC to provide cancer care to the underserved minority population of LAC, including clinical trials. As a result, between 2015-2022 a total of 120 LAG patients were accrued to phase I clinical trials; enrolled subjects were 66% Hispanic, 21% Asian, 4% Black, and 9% other. An interventional study was designed to further enhance the referral and participation of racial and ethnic minority patients from other Los Angeles County (LAC) safety-net facilities. The study is funded by the Stand up to Cancer Diversity in Early Development Clinical Trials Research Grants Program.

Methods:This interventional study has 3 specific aims. First, to identify barriers to referral for minority and underserved patients: Qualitative interviews will be conducted with key stakeholders in the LAC safety net system which will uncover barriers to referring minority and underserved patients. A screening tool developed by the NCI to characterize barriers will be used. Second, to implement a multi-component program to enhance the referral of patients to early-phase clinical trials. The intervention addresses system-level, provider-level, and patient-level factors to improve the process, with a demonstration site compared to a non-demonstration site. Key features include a streamlined referral process for healthcare professionals with a singular centrally operated email managed by a specialized facilitator, weekly meetings to assign trials to prospective patients, and facilitation of approval and scheduling for referrals. We will educate providers regarding trials and exchange feedback on the referral process. We will extend resources to patients to assist with financial and transportation limitations. We will compare change in referral and enrollment rates at baseline and after the intervention for both the demonstration site and non-demonstration site. Third, to explore the impact of remotely conducted clinical trials: A clinical trial (NCT05340309) administers study drug subcutaneously and uses telemedicine visits, wearable sensors, and a smartphone app for monitoring. This pilot trial will be analyzed to determine the model’s impact on barriers to enrollment. The above interventions may provide a model that can be adapted in other healthcare delivery settings to optimize referral and enrollment of racial and ethnic minorities.

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