Abstract
IMPORTANCE: Patient-staff interactions in clinical trials may influence future enrollment decisions among racial and ethnic minority patients, who remain underrepresented in clinical research. A scale that measures common patient-staff interactions encountered by racial and ethnic minority patients in clinical trials may help improve patient experience and enrollment outcomes. OBJECTIVE: To develop and validate a scale that measures common interactions encountered by racial and ethnic minority patients in clinical trials. DESIGN, SETTING, AND PARTICIPANTS: This mixed-methods survey study involved interviews and online surveys for data collection between April 1, 2023, and June 30, 2024. Adult (aged ≥18 years) racial and ethnic minority patients were interviewed to identify common interactions with research staff. The survey was validated across potential clinical trial participants and among former clinical trial participants. MAIN OUTCOMES AND MEASURES: Fit statistics for exploratory factor analysis and confirmatory factor analysis were used to confirm the validity of the scale. Structural equation modeling coefficients were used to assess the validity of the scale for measuring patients' trust toward the research staff and willingness to participate in future studies. RESULTS: The sample include 1113 participants. The scale item derivation cohort comprised 16 racial and ethnic minority participants with clinical trial experience (mean [SD] age, 44.9 [12.9] years; 10 female [62.5%]; 3 identifying as Asian or Pacific Islander [18.8%], 9 as Black [56.3%], 3 as Latino [18.8%], and 1 as multiracial [6.3%]). The scale structure validation cohort of potential clinical trial participants comprised 479 survey respondents (mean [SD] age, 35.5 [11.9] years; 219 women [45.7%]; 1 identifying as American Indian [0.2%], 59 as Asian or Pacific Islander [12.3%], 266 as Black [55.5%], 59 as Latino [12.3%], and 86 as multiracial [19.7%]). The concurrent validation cohort included 618 participants (mean [SD] age, 45.3 [16.3] years; 53% male; 63 identifying as Asian or Pacific Islander [10.2%], 228 as Black [36.9%], 75 as Latino [12.1%], 223 as White [36.1%], and 29 as multiracial [4.7%]). The 22-item Clinical Research Interaction Scale had high reliability (α = 0.96) and validity (comparative fit index, 0.92; Tucker-Lewis index, 0.91; root mean square error of approximation, 0.08). Patient experience of frequent low-quality interactions was significantly associated with lowered trust toward research staff (β, -0.56; 95% CI, -0.74 to -0.37), which in turn significantly lowered patients' willingness to return to the site for future studies (β, 0.80; 95% CI, 0.70-0.90). CONCLUSIONS AND RELEVANCE: These findings suggest that low-quality interactions with research staff may reduce racial and ethnic minority patients' willingness to return for future studies, mediated by lowered trust toward the staff. The Clinical Research Interaction Scale may be a useful tool to improve the experience and enrollment outcomes for racial and ethnic minorities in clinical trials.