Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Nov 1;141(11):1037-1044.
doi: 10.1001/jamaophthalmol.2023.4638.

Diverse Research Teams and Underrepresented Groups in Clinical Studies

Ashank Bains  1 , Pawarissara Osathanugrah  2 , Nayan Sanjiv  2 , Cedrick Chiu  3 , Marissa G Fiorello  2 , Nicole H Siegel  2   4 , Crandall E Peeler  2   4 , Alberto G Distefano  2   4 , Hyunjoo J Lee  2   4 , Steven Ness  2   4 , Manishi A Desai  2   4 , Jenna R Titelbaum  2   4 , Tony Pira  2   4 , Kara C LaMattina  2   4 , Stephen P Christiansen  2   4   5 , Howard J Cabral  6 , Manju L Subramanian  2   4
Affiliations

Diverse Research Teams and Underrepresented Groups in Clinical Studies

Ashank Bains et al. JAMA Ophthalmol. .

Abstract

Importance: Several ophthalmic diseases disproportionately affect racial and ethnic minority patients, yet most clinical trials struggle to enroll cohorts that are demographically representative of disease burden; some barriers to recruitment include time and transportation, language and cultural differences, and fear and mistrust of research due to historical abuses. Incorporating diversity within the research team has been proposed as a method to increase trust and improve engagement among potential study participants.

Objective: To examine how demographic factors of potential research participants and personnel may be associated with patient consent rates to participate in prospective ophthalmic clinical studies.

Design, setting, and participants: This retrospective cohort study included patients from an urban, academic hospital who were approached for consent to participate in prospective ophthalmic clinical studies conducted between January 2015 and December 2021.

Main outcomes and measures: Multivariable logistic regression assessing associations between patient and research personnel demographics and rates of affirmative consent to participate was used.

Results: In total, 1380 patients (mean [SD] age, 58.6 [14.9] years; 50.3% male) who were approached for consent to participate in 10 prospective ophthalmic clinical studies were included. Of prospective patients, 566 (43.5%) were Black; 327 (25.1%), Hispanic or Latino; 373 (28.6%), White; 36 (2.8%), other race and ethnicity; and 78 (5.8%) declined to answer. 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 compared with White patients. Patients with lower socioeconomic status were less likely to consent than patients with higher socioeconomic status (OR, 0.43; 95% CI, 0.33-0.53; P < .001). Concordance between patient and research staff race and ethnicity was associated with increased odds of affirmative consent (OR, 2.72; 95% CI, 1.99-3.73; P < .001).

Conclusions and relevance: In this cohort study, patients from underrepresented racial and ethnic groups and those with lower socioeconomic status were less likely to participate in ophthalmic clinical studies. Concordance of race and ethnicity between patients and research staff was associated with improved participant enrollment. These findings underscore the importance of increasing diversity in clinical research teams to improve racial and ethnic representation in clinical studies.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Ness reported receiving grants from the National Institutes of Health (NIH) and the Diabetic Retinopathy Clinical Research (DRCR) Network and receiving personal fees from the DRCR Network outside the submitted work. Dr Christiansen reported serving on the scientific advisory board for iVeena Delivery Systems, receiving grants from the NIH, and being a consultant for Laboratoires Thea outside the submitted work. Dr Subramanian reported receiving grants from the NIH and research support from Novartis and DRCR.net. No other disclosures were reported.

References

    1. Malhotra NA, Greenlee TE, Iyer AI, Conti TF, Chen AX, Singh RP. Racial, ethnic, and insurance-based disparities upon initiation of anti-vascular endothelial growth factor therapy for diabetic macular edema in the US. Ophthalmology. 2021;128(10):1438-1447. doi:10.1016/j.ophtha.2021.03.010 - DOI - PubMed
    1. Emanuele N, Sacks J, Klein R, et al. ; Veterans Affairs Diabetes Trial Group . Ethnicity, race, and baseline retinopathy correlates in the Veterans Affairs diabetes trial. Diabetes Care. 2005;28(8):1954-1958. doi:10.2337/diacare.28.8.1954 - DOI - PubMed
    1. Stein JD, Kim DS, Niziol LM, et al. . Differences in rates of glaucoma among Asian Americans and other racial groups, and among various Asian ethnic groups. Ophthalmology. 2011;118(6):1031-1037. doi:10.1016/j.ophtha.2010.10.024 - DOI - PMC - PubMed
    1. Osathanugrah P, Sanjiv N, Siegel NH, Ness S, Chen X, Subramanian ML. The impact of race on short-term treatment response to bevacizumab in diabetic macular edema. Am J Ophthalmol. 2021;222:310-317. doi:10.1016/j.ajo.2020.09.042 - DOI - PubMed
    1. Al-Moujahed A, Vail D, Do DV. Racial differences in anti-VEGF intravitreal injections among commercially insured beneficiaries. Ophthalmic Surg Lasers Imaging Retina. 2021;52(4):208-217. doi:10.3928/23258160-20210330-05 - DOI - PubMed

Publication types