Abstract IA028: Achieving health equity: Inclusive participation in clinical trials

Abstract

Abstract Minority participation in clinical trials is imperative to develop new prevention, detection, and treatment modalities for cancer because study samples must be representative to generalize findings to the disease population. As of 2020, low-SES populations, which have minority race/ethnicity prevalence, saw significantly greater risk from cancer mortality than their White, higher-income counterparts. This population has higher mortality from breast cancer (+10%), prostate cancer (+16%), colorectal cancer (+17%), and liver cancer (+26).1-2 Myriad drivers of health inequities3 act as barriers to clinical trial participation.1 Patient barriers include sociocultural and physical environment factors, while physician’ barriers include perceived loss of control, uncertainty, and lack of time to discuss research options.1 For example, 87% of patients surveyed in 2020 reported never having been invited to participate in a clinical trial with 41% not knowing anything about clinical trials; 9% had been asked, with <5% participating. Disparities were evident by minority race, low education level and income, and rurality.1,4 Retention and compliance barriers included participants’ loss of interest in the study, not having been assigned to a desired treatment, older age, low education, unemployment, and logistical barriers, such as transportation and child-care.4-5 Incorporating patient navigation programs into clinical trials helps correct for misinformation and builds trust between researchers and community members.5-7 The Increasing Minority Participation in Clinical Trials (IMPaCT) study (2007-2014, N=272), trained lay patient navigators (PNs) to guide patients through the eligibility process to enroll in cancer clinical trials at UAB. PNs also provided tailored support, including assistance with transportation and lodging, appointment reminder calls, social service referrals as appropriate, and linking patients with peer support. African American participation in therapeutic cancer clinical trials increased from 9% to 16%.4,6 UAB has had similar success with other patient navigation and health coaching studies, confirming PN benefits.8-10 An often overlooked barrier is researcher or physician implicit bias and the role bias plays in study design, particularly with regard to participant recruitment.11 Although everyone has biases, acknowledging how those biases affect our judgement and behaviors can be uncomfortable to process.12 When we address bias directly and take purposeful actions to mitigate implicit bias, patients benefit, enrollment increases among the populations most at risk, and results become generalizable.13-14 With the increasing amount of readily-available population-level data on incidence and mortality from various types of cancer registries, likely barriers to participation, including both patient-and researcher-centered, can be identified early in a study’s development and addressed during plan development. Finally, incorporating patient navigation into recruitment plans will enhance enrollment in cancer clinical trials. Citation Format: Mona N. Fouad. Achieving health equity: Inclusive participation in clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr IA028.