Examining opportunity for cancer clinical trial participation among under-represented groups

Recent evidence suggests racial/ethnic minorities, older adults and the economically disadvantaged are willing to participate in cancer clinical trials (CCTs) but may lack the opportunity to do so. We define opportunity for participation as an offer from a healthcare provider or researcher for screening and/or enrollment in a CCT. A barrier/promoter of opportunity for participation is eligibility, or the key attributes/characteristics a person must have in order to participate in a CCT. We have limited understanding of the roles of opportunity and eligibility for participation in CCTs and how this may contribute to under-representation. The primary objective of this dissertation was to examine whether opportunity and eligibility for cancer clinical trial participation differs between under-represented and well-represented groups based on socio-demographic and disease characteristics. Using Ford\u27s conceptual framework for examining participation of under-represented groups in CCTs, we performed a cross-sectional matched cohort study in a large academic comprehensive cancer center. We enrolled 88 new cancer patients (44 Black or Hispanic, 44 Non-Hispanic White), matched on age (± 5 years) and cancer type (breast, lung, kidney or leukemia). We collected information on opportunity, eligibility, socio-demographic/disease characteristics and reasons for exclusion via a participant questionnaire, and with participant permission, a retrospective electronic medical record (EMR) review. We examined differences using Fisher\u27s exact tests, t-tests and ANOVA. Most of the sample reported no opportunity for CCT participation (79%) and were ineligible for accruing trials (84%). Those with Stage III/IV disease were significantly more likely to have opportunity (p=.001) and be eligible for participation (p=\u3c.001). Differences in opportunity and eligibility were predominantly associated with disease characteristics, as opposed to socio-demographic characteristics. Common reasons for exclusion included other (a combination of categories primarily suggesting advanced disease), prior therapy, and lack of required therapy (per study eligibility criteria). Results suggest lack of available trials, poor patient-trial fit and stringent eligibility criteria limit opportunity across populations. Opportunity and eligibility likely vary based on complex intersections between race, ethnicity, age, SES and disease characteristics, as well as differences in the healthcare setting. Future research should explore these intersections and how they influence under-representation in opportunity for CCT participation