Racial, Ethnic Concordance Improves Ophthalmic Clinical Trial Enrollment

Manju L. Subramanian, MD

Credit: Boston University

Individuals from underrepresented racial and ethnic groups, as well as those with lower socioeconomic status, were less likely to consent to participate in ophthalmic clinical trials, according to new research.¹

The retrospective cohort study, consisting of patients from an urban academic hospital, found the concordance of race and ethnicity between patients and research staff was linked to a greater likelihood of participant consent and enrollment.

“Our finding that participants being approached by a research team member of a shared race and ethnicity were positively associated with successful recruitment underscores the need to increase the diversity of research teams to improve racial and ethnic minority patient representation in clinical studies,” wrote the investigative team, led by Manju L. Subramanian, MD, of the department of ophthalmology, Boston Medical Center.

Racial and ethnic disparities are widespread across medicine, particularly regarding care access in the United States, despite national efforts to eliminate these differences.² Many ophthalmic diseases disproportionately affect patients of racial and ethnic minority groups, but clinical trials often struggle to recruit representative cohorts of the disease burden.

These disparities can be associated with issues related to time, transportation, and language differences, as well as structural inequities, including historical abuse and unethical practices in medical research. Subramanian and colleagues noted an improved understanding of the enrollment of underrepresented patients in clinical research is critical, for the provision of proper care for all patients.¹

The analysis examined how demographic-related factors of potential research participants and personnel may be associated with consent rates to participate in prospective clinical trials. Subramanian and the team hypothesized that participation would increase with increased diversity on a clinical trial team, and the ability to communicate with patients in their primary language.

Screening logs from 10 prospective ophthalmic clinical studies conducted between January 2015 and December 2021 from the investigators’ urban, academic hospital were examined for analysis. The logs were used to document patients who were approached by research personnel for study participation during the study recruitment stage.

Electronic medical records of patients provided data on age, sex, race, ethnicity, address, primary or preferred language, and primary insurance. Research personnel, including the same variables, were gathered via voluntary survey. Socioeconomic status was included for analysis using the surrogate Area Deprivation Index (ADI) measure.

Overall, 1380 patients approached for consent to participate in the 10 prospective ophthalmic clinical studies were included in the analysis. Patients had a mean age of 58.6 years and were 50.3% male. Of these prospective patients, 566 (43.5%) were Black, 327 were Hispanic or Latino, 373 (28.6%) were White, 36 (2.8%) reported other race and ethnicity, and 78 (5.8%) declined to answer.

Bivariate analyses revealed a higher rate of consent among male patients (48.1%) than female patients (41.3%), as well as in White patients (60.1%) compared with Black (36.9%) and Hispanic or Latino patients (41.0%). Those with higher socioeconomic status also consented to study participation at higher rates than those with lower status (51.3% vs. 32.5%; P <.001).

Multivariable logistic regression models were used to further analyze these associations, after controlling for study confounders. Results showed Black patients (odds ratio [OR], 0.32; 95% CI, 0.24 - 0.44; P <.001) and Hispanic or Latino patients (OR, 0.31; 95% CI, 0.20 - 0.47; P <.001) were less likely to consent to study participation compared with White patients.

Participants with lower socioeconomic status were found less likely to consent than patients with higher socioeconomic status (OR, 0.43; 95% CI, 0.33 - 0.53; P <.001). Concordance in race and ethnicity between the research team member and study participants was associated with increased odds of affirmative study consent (OR, 2.72; 95% CI, 1.99 - 3.73; P <.001), regardless of language or sex concordance.

Subramanian and colleagues noted the initial face-to-face conversations between study participants and research personnel can be comprehensive and time-consuming. As a result, patients may confirm their decision to participate in a trial based on a first impression of the research team.

“Inclusion of a diverse team of RAs may therefore foster increased patient confidence and trust in the research process, leading to improved recruitment, but this is just a start,” investigators wrote. “Even more challenging will be ensuring representation within the whole team, including research managers and investigators who hold the power to make critical decisions in research design.”

References

1. _{Bains A, Osathanugrah P, Sanjiv N, et al. Diverse Research Teams and Underrepresented Groups in Clinical Studies. JAMA Ophthalmol. Published online October 19, 2023. doi:10.1001/jamaophthalmol.2023.4638}
2. _{Mahajan S, Caraballo C, Lu Y, et al. Trends in Differences in Health Status and Health Care Access and Affordability by Race and Ethnicity in the United States, 1999-2018. JAMA. 2021;326(7):637–648. doi:10.1001/jama.2021.9907}