Influence of Cost-Related Considerations on Clinical Trial Participation: Results from the 2020 Health Information National Trends Survey (HINTS)

Abstract

Background People experiencing financial burden are underrepresented in clinical trials . Objective Describe the prevalence of cost-related considerations influential to trial participation and their associations with person-level characteristics. Design This cross-sectional study used and assessed how three cost-related considerations would influence the decision to participate in a hypothetical clinical trial. Participants A total of 3682 US adult respondents to the Health Information National Trends Survey Main Measures Survey-weighted multivariable logistic regression estimated associations between respondent characteristics and odds of reporting cost-related considerations as very influential to participation. Key Results Among 3682 respondents, median age was 48 (IQR 33–61). Most were non-Hispanic White (60%), living comfortably or getting by on their income (74%), with ≥ 1 medical condition (61%). Over half (55%) of respondents reported at least one cost-related consideration as very influential to trial participation, including if usual care was not covered by insurance (reported by 42%), payment for participation (24%), or support for participation (24%). Respondents who were younger (18–34 vs. ≥ 75, adjusted odds ratio [aOR] 4.3, 95% CI 2.3–8.1), more educated (high school vs. <high school, aOR 2.1, 95% CI 1.1–4.1), or with lower perceived income (having difficulty vs. living comfortably, aOR 2.1, 95% CI 1.1–3.8) had higher odds of reporting any cost-related consideration as very influential to trial participation. Non-Hispanic Black vs. non-Hispanic White respondents had 29% lower odds (95% CI 0.5–0.9) of reporting any cost-related consideration as very influential to trial participation. Conclusions Cost-related considerations would influence many individuals’ decisions to participate in a clinical trial, though prevalence of these concerns differed by respondent characteristics. Reducing financial barriers to trial participation may promote equitable trial access and greater trial enrollment diversity. Supplementary Information The online version contains supplementary material available at 10.1007/s11606-022-07801-0.

Understanding the financial cost of cancer clinical trial participation

“…Our previous study of >3500 US adults nationwide found that respondents with lower perceived income had double the odds of reporting a cost‐related consideration as very influential to clinical trial participation than those with higher perceived income, even after accounting for patient age, race, and residence 18 . However, respondents from this study were disease‐agnostic and were considering hypothetical clinical trial participation.…”

“…Our previous study of >3500 US adults nationwide found that respondents with lower perceived income had double the odds of reporting a cost‐related consideration as very influential to clinical trial participation than those with higher perceived income, even after accounting for patient age, race, and residence. 18 However, respondents from this study were disease‐agnostic and were considering hypothetical clinical trial participation. Little is known about trial‐related financial hardship, defined as high out‐of‐pocket costs and accompanying financial distress, 19 and its impact on patients with financial barriers to care considering or participating in cancer‐specific clinical trials.…”

The influence of political ideology on clinical trial knowledge, invitation, and participation among adults in the United States

“…Covariates included in this study were informed by prior literature delineating factors associated with clinical trial knowledge and participation. 5,8 The specific sociodemographic variables and health-related variables included in this study were age (18-34 years, 35-49 years, 50-64 years, and 65 years or older), sex, race/ethnicity (White, Black or African American, Hispanic, and others), educational level (high school graduate or less, some college, college graduate, and postgraduate), marital status, household income (less than US$20k, US$20k to less than US$35k, US$35k to less than US$50k, US$50k to less than US$75k, and US$75k or above), having a regular provider, presence of comorbidities (one or more of the following conditions: diabetes mellitus, hypertension, heart disease, lung disease, or previous cancer diagnosis), and rural-urban residence.…”

“…Previous studies have documented racial, economic, individual, and geographic disparities in clinical trial participation. [5][6][7][8][9][10] This discrepant inclusion of certain sub-populations may widen already existing health disparities among underserved populations. Thus, efforts to increase diverse participation in clinical trials in the United States are warranted.…”