Clinical trial participation assessed by age, sex, race, ethnicity, and socioeconomic status
Saphner T, Marek A, Homa JK, Robinson L, Glandt N. Clinical trial participation assessed by age, sex, race, ethnicity, and socioeconomic status. Contemp Clin Trials. 2021;103:106315. doi: 10.1016/j.cct.2021.106315
INTRODUCTION: Individual demographic data and socioeconomic status (SES) factors from Census block group data may help define groups with disadvantaged access to clinical trials.
METHODS: Individual demographic data from the Aurora Cancer Registry and SES factors corresponding to the Census block group of the patient's address were studied for a six-year period ending July 31, 2019.
RESULTS: The final study cohort included 39,968 patients (enrolled = 772, and not enrolled = 39,196). In univariate analysis, significantly fewer patients older than age 65 (p < 0.001) and fewer men (p < 0.001) were enrolled in clinical trials. Socioeconomic factors found to be significant during univariate analysis included: low household income (p < 0.001), percentage below the poverty line (p < 0.001), low percentage home ownership (p = 0.006), unemployment (p = 0.003), absence of a college degree (p = 0.037) and absence of a high school degree (p = 0.007). In multivariate analysis, patients older than age 65 were less likely to participate in a trial (odds ratio 0.574, p < 0.001) and men were less likely to participate (odds ratio = 0.703, p < 0.001). Only 1.4% of the variance in clinical trial participation was accounted for demographic and SES factors.
CONCLUSIONS: The only groups with disadvantaged access to clinical trials in our institution were the elderly and men. Whether demographic or SES factors are related to accrual rates of clinical trials in other geographic regions or in other types of research studies warrants further investigation.