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. 2022 Oct 6;140(11):1096–1102. doi: 10.1001/jamaophthalmol.2022.3929

Representation of Race and Ethnicity in Randomized Clinical Trials of Diabetic Macular Edema and Retinal Vein Occlusion Compared to 2010 US Census Data

Abdul-Hadi Kaakour 1, Hong-Uyen Hua 1, Aleksandra Rachitskaya 1,✉
PMCID: PMC9539735  PMID: 36201192

Key Points

Question

How does the distribution of race and ethnicity in randomized clinical trials of diabetic macular edema (DME) and macular edema from retinal vein occlusions (RVO) compare to the 2010 US Census data?

Findings

This cross-sectional study of 9924 participants found that the demographic distribution of race and ethnicity in most trials did not reflect that of the US population according to the 2010 US Census. Participants identifying as White tended to be overrepresented.

Meaning

These findings suggest that more work is needed to recruit and better represent racial and ethnic minority groups in DME and RVO randomized clinical trials.

This cross-sectional study evaluates the representation of racial and ethnic minority groups in randomized clinical trials of diabetic macular edema and retinal vein occlusion compared with US Census data.

Abstract

Importance

Diverse enrollment and adequate representation of racial and ethnic minority groups in randomized clinical trials (RCTs) are valuable to ensure external validity and applicability of results.

Objective

To compare the distribution of race and ethnicity in RCTs of diabetic macular edema (DME) and macular edema from retinal vein occlusion (RVO) to that of US Census data.

Design, Setting, and Participants

This was a cross-sectional retrospective analysis comparing racial and ethnic demographic characteristics of US-based RCTs of DME and RVO between 2004 and 2020 with 2010 US Census data. PubMed and ClinicalTrials.gov were searched to screen for completed phase 3 RCTs with published results. Of 169 trials screened, 146 were excluded because they were incomplete, did not report race and ethnicity, or were not based in the US, and 23 trials were included (15 DME and 8 RVO). The number and percentage of American Indian or Alaska Native, Asian, Black, Hispanic, Native Hawaiian or Other Pacific Islander, and White participants was recorded in each RCT. The demographic distribution and proportion was compared to the reported distribution and proportion in the 2010 US Census using the χ2 test.

Main Outcomes and Measures

Overrepresentation, underrepresentation, or representation commensurate with 2010 US Census data in the racial and ethnic populations of RCTs of retinal vascular disease.

Results

In 23 included RCTs of DME and RVO, there were a total of 38 participants (0.4%) who identified as American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander (groups combined owing to small numbers), 415 Asian participants (4.4%), 904 Black participants (9.6%), 954 Hispanic participants (10.1%), and 7613 White participants (80.4%). By comparison, the 2010 US Census data indicated that 1.1% of the US population self-reported as American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander (groups combined for comparison in this study), 4.8% self-reported as Asian, 12.6% as Black or African American, 16.3% as Hispanic, and 63.7% as White. American Indian or Alaska Native and Hawaiian or Other Pacific Islander participants were underrepresented in 2 trials, neither overrepresented nor underrepresented in 20, and not overrepresented in any of the included trials. Asian participants were underrepresented in 10 trials, overrepresented in 4, and neither overrepresented nor underrepresented in 8. Black participants were underrepresented in 9 trials, overrepresented in 2, and neither overrepresented nor underrepresented in 11. Hispanic participants were underrepresented in 15 trials, overrepresented in 2, and neither overrepresented nor underrepresented in 5. White participants were underrepresented in 2 trials, overrepresented in 14, and neither overrepresented nor underrepresented in 7. The χ2 values comparing RCT demographic distribution to US 2010 Census data were significantly different in 22 of 23 included RCTs.

Conclusions and Relevance

The findings in this study indicated a discrepancy between racial and ethnic demographic data in RCTs of DME and RVO and the US population according to the 2010 Census. White study participants were most frequently overrepresented, and Hispanic study participants were most frequently underrepresented. These findings support the need for more efforts to recruit underrepresented racial and ethnic minorities to improve external validity in trial findings.

Introduction

Based on 2020 US Census data, the US population has continued to increase in racial and ethnic diversity.1 As health care professionals, and as ophthalmologists, we are charged with providing optimal care for this increasingly diverse population.2 Diverse populations have diverse needs, and numerous epidemiological studies have demonstrated racial and ethnic differences in eye disease prevalence and course of progression.3,4 Unfortunately, despite the availability of newer treatments and modalities, disparities in outcomes persist.

Randomized clinical trials (RCTs), which can minimize bias and provide strong clinical evidence that can change clinical practice, often represent a high standard of evidence-based medicine. To provide evidence-based care, it is important that RCTs strive to represent real-world populations. Poor representation may affect the external validity of studies and limit applications to underrepresented sociodemographic minorities.5 In fact, the National Academy of Medicine (formerly the Institute of Medicine) and the American College of Physicians remarked that underrepresentation in clinical trials serves to deepen preexisting disparities, and the National Institutes of Health has enacted policies in an effort to stymie this effect.6,7,8 However, the persistence of underrepresentation of minority groups continues to be well described across the medical literature, and ophthalmology has been no exception.9,10,11,12,13 A study examining the representation of race and ethnicity in studies for new ocular molecular entities between 2006 and 2016 found no change in the composition of participants in RCTs and concluded that most participants were female individuals who identified as White.14

In ophthalmology, the greatest number of RCTs have been conducted on diseases of the retina, which include diabetic and hypertensive eye disease as among the most prevalent disorders.15 These disorders are no exception to disparities in care. Diabetes remains more prevalent in African American and Hispanic populations than in White populations, and these groups experience visual impairment from diabetes-related complications at 1.4-fold and 1.5-fold the rate among White individuals in the US, respectively.16,17,18,19 Incidence of retinal vein occlusions (RVOs) and hypertension are at least as or more prevalent in Hispanic and Black populations than White populations, respectively.20,21,22 However, the extent of population-based representation of racial and ethnic groups in RCTs is unknown. This study sought to explore the distribution of race and ethnicity in RCTs of diabetic macular edema (DME) and macular edema from RVO compared to 2010 US Census data.

Methods

Institutional review board approval was not required for this study because no protected patient information was accessed. The study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline. We performed a retrospective cross-sectional study of the racial and ethnic demographic data of all completed phase 3 RCTs for DME and RVO as of May 2021 and compared them to 2010 US Census data. We initially identified 21 trials for DME and 10 for RVO. Trials that had no study centers in the US were removed from analysis, as well as trials that did not completely report race and ethnicity data. This process was undertaken to prevent bias in the selection of included studies and is summarized in Figure 1. eTable 1 in the Supplement provides a list of trials screened and the specific reason for exclusion for each trial. Indication, years of study activity, number of enrolled and randomized study participants, and race and ethnicity breakdown of all trials were recorded. When these data were not reported in the main methods section of the paper, appendices and supplemental information sections were used. Additionally, the number and percentage of American Indian or Alaska Native, Asian, Black, Hispanic, Native Hawaiian or Other Pacific Islander, and White participants were recorded. If the data were not available, the value was indicated as unreported. For statistical evaluation, unreported values were treated as null, with the assumption that if not explicitly mentioned, the study did not recruit any study participants of that racial or ethnic category. Study participants who were identified as other, unknown, or more than 1 race were recorded for the purpose of data analysis but the data were treated as null values in both the numerator and denominator to avoid skewing the analysis. This was most salient in 1 RVO trial, as only the number of White study participants and number of total study participants in the study were reported.23

Figure 1. Flow Diagram for Inclusion of Identified Studies.

Figure 1.

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DME indicates diabetic macular edema; RVO, retinal vein occlusions.

Publicly available 2010 US Census data were used. We chose to compare demographic characteristics to US 2010 Census data as 2010 reflected the closest proximity in time, on average, to the RCTs examined. In addition, the 2020 data were still in collection and unavailable at the time of data analysis. The demographic distribution of each RCT was compared to the reported distribution of the 2010 US Census demographic data using the χ2 test. We were unable to perform a χ2 test for the 1 RCT that only provided racial demographic data for White study participants.23 The proportion of each race or ethnicity was compared to its reported proportion from the 2010 Census data using 1-sample z test. These values were calculated in Excel version 2207 (Microsoft). A more stringent significance threshold of P < .01 was used given the multiple analyses performed. P values were 2-sided but were not adjusted for multiple analyses.

Results

After selecting for completed US-based RCTs that included race and ethnicity information, 15 DME and 8 RVO trials were available for analysis (Table). These trials ranged from opening as early as 2004 to ending as recent as 2020. There were a total of 38 participants (0.4%) who identified as American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander (groups combined owing to small numbers), 415 Asian participants (4.4%), 904 Black participants (9.6%%), 954 Hispanic participants (10.1%), and 7613 White participants (80.4%) in the included RCTs. By comparison, the 2010 US Census data indicated that 1.1% of the US population self-reported as American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander (groups combined for comparison in this study), 4.8% self-reported as Asian, 12.6% as Black or African American, 16.3% as Hispanic, and 63.7% as White.

Table. Randomized Clinical Trials of Diabetic Macular Edema and Retinal Vein Occlusion Reviewed for Analysis.

Trial Trial short code Study completion year Participant enrollment, No.
Diabetic macular edema
Diabetic Retinopathy Clinical Research Network,24 2008 DRCR Retina Network Protocol B 2008 840
Massin et al,25 2010 RESOLVE 2008 151
Do et al, 26 2012 Da Vinci 2010 219
Googe et al,27 2011 DRCR Retina Network Protocol J 2010 345
Sultan et al,28 2011 Macugen (NCT00605280) 2011 260
Nguyen et al,29 2012 RISE 2012 377
Nguyen et al,29 2012 RIDE 2012 382
Do et al,30 2015 READ-3 2013 152
Prünte et al,31 2016 RETAIN 2013 372
Elman et al,32 2010 DRCR Retina Network Protocol I 2013 854
Korobelnik et al,33 2014 VIVID 2015 403
Korobelnik et al,33 2014 VISTA 2015 459
Wells et al,34 2015 DRCR Retina Network Protocol T 2018 660
Baker et al,35 2019 DRCR Retina Network Protocol V 2018 702
Antoszyk et al,36 2020 DRCR Retina Network Protocol AB 2020 205
Retinal vein occlusion
Haller et al,37 2010 GENEVA 2008 1267
Ip et al,23 2009 SCORE 1 2009 682
Campochiaro et al,38 2010 BRAVO 2009 397
Brown et al,39 2010 CRUISE 2009 392
Campochiaro et al,40 2014 SHORE 2012 202
Boyer et al,41 2012 COPERNICUS 2012 188
Holz et al,42 2013 GALILEO 2012 172
Scott et al,43 2017 SCORE 2 2016 362
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DME

Compared to the 2010 US Census data, in the 15 RCTs for DME treatment, the American Indian or Alaska Native and Hawaiian or Other Pacific Islander study participant cohort (groups combined owing to small numbers) was underrepresented in 1 RCT32 and neither overrepresented nor underrepresented in 14. The Asian study participant cohort was underrepresented in 7 trials,24,27,31,32,33,34,35 overrepresented in 2,28,33 and neither overrepresented nor underrepresented in 6.25,26,29,30,36 The Black study participant cohort was underrepresented in 6 RCTs,24,25,26,28,31,33 overrepresented in 2,32,35 and neither overrepresented nor underrepresented in 7.24,29,30,33,34,36 The Hispanic study participant cohort was underrepresented in 9 trials,23,25,26,28,31,32,33 overrepresented in 2,27,29 and neither overrepresented nor underrepresented in 4.29,30,34,35 The White study participant cohort was underrepresented in 2 RCTs,30,36 overrepresented in 9,24,25,26,28,29,31,32,33 and neither overrepresented nor underrepresented in 4.27,29,34,35 These data are summarized in Figure 2. eTable 2 in the Supplement summarizes the proportions of each demographic cohort recruited in each study compared to the expected proportions as per the 2010 US Census, with P values for the 1-sample z test and 99% CIs listed for each clinical trial used in this study for analysis. The χ2 values comparing RCT demographic distribution to US 2010 Census data were significantly different in 15 of 15 RCTs.

Figure 2. Underrepresentation and Overrepresentation of Race and Ethnicity in Diabetic Macular Edema Trials Compared to US 2010 Census Data.

Figure 2.

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Macular Edema From RVO

In the 8 RCTs for RVO treatment, 1 trial23 only included data for White participants. The White study participant cohort was overrepresented in 5 of these 8 RCTs,23,37,38,39,40 neither overrepresented nor underrepresented in 3,41,42,43 and not underrepresented in any of the RVO trials. Of the remaining 7 RVO trials, the American Indian or Alaska Native and Hawaiian or Other Pacific Islander study participant cohort was underrepresented in 1 RCT37 and neither overrepresented nor underrepresented in 6.38,39,40,41,42,43 The Asian study participant cohort was underrepresented in 3 trials,38,39,43 overrepresented in 2,37,42 and neither overrepresented nor underrepresented in 2.40,41 The Black study participant cohort was underrepresented in 3 RCTs37,41,42 and neither overrepresented nor underrepresented in 4 trials.38,39,40,43 The Hispanic study participant cohort was underrepresented in 6 RCTs37,38,39,40,42,43 and neither overrepresented nor underrepresented in 1.41 These data are summarized in Figure 3. The χ2 values comparing RCT demographic distribution to US 2010 Census data were significantly different in 6 of 6 RCTs for which χ2 tests could be performed. We could not perform a χ2 test for the SCORE 1 trial,23 which only included racial data for White study participants. eTable 3 in the Supplement summarizes the proportions of each demographic cohort recruited in each study compared to the expected proportions as per the 2010 US Census, with the 99% CIs listed for each clinical trial used in this study.

Figure 3. Underrepresentation and Overrepresentation of Race and Ethnicity in Retinal Vein Occlusion Trials Compared to US 2010 Census Data.

Figure 3.

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aWhite demographic included 1 additional randomized clinical trial, as 1 trial only provided racial and ethnic data for White participants.

Results Summary

In the 23 RCTs for DME and RVO, American Indian or Alaska Native and Hawaiian or Other Pacific Islander study participants were underrepresented in 2 RCTs, neither overrepresented nor underrepresented in 20, and not overrepresented in any of the included trials. Asian participants were underrepresented in 10 trials, overrepresented in 4, and neither overrepresented nor underrepresented in 8. Black participants were underrepresented in 9 trials, overrepresented in 2, and neither overrepresented nor underrepresented in 11. Hispanic participants were underrepresented in 15 trials, overrepresented in 2, and neither overrepresented nor underrepresented in 5. White participants were underrepresented in 2 trials, overrepresented in 14, and neither overrepresented nor underrepresented in 7.

Discussion

Although the chance that in the US, 2 individuals chosen at random are 6.2% more likely to be from different racial or ethnic backgrounds in 2020 than in 2010, clinical trials continue to underrepresent minorities and possibly contribute to continued health care disparities. Many racial and ethnic groups continue to be underrepresented in studies of retinal disease as well, even though epidemiologic and demographic studies over the past 30 years have demonstrated that racial and ethnic minority groups and individuals of specific racial status are at greater risk of developing entities such as DME.7,8 Our study demonstrates the need for increased diversity and racial representation in recruiting for trials and in evaluating DME and RVO treatment trials based on the finding that the number of underrepresented minority individuals in retinal vascular RCTs was out of proportion to the racial and ethnic composition of the US population.

Limitations

There have been a few recent studies examining the underrepresentation of Black and Hispanic populations in DME and diabetic retinopathy trials. This study joins the call for improved representation but differs in a few key ways.44,45 RCT populations in this article were compared to corresponding demographic characteristics as reported in the US Census instead of to treatment databases. Further, this study explores the representation of race and ethnicity in treatment for both DME and RVO, an approach that provides a summary of the level of representation of each group across the body of the retinal vascular disease literature. In our initial analysis of 32 trials, we observed that race and ethnicity reporting is inconsistently and heterogeneously gathered and reported, if it is reported at all. This naturally led to a limitation to our study. However, this observation supports a recent publication that found that of articles published in the ophthalmic literature in 2019, 43% reported study participant race and ethnicity.46 When these data were included, 78 distinct categories of race and ethnicity were identified. Clinical trialists are not without guidance on this matter: the US Food and Drug Administration (FDA) Office of Minority Health produced a document47 in 2016 that explicitly outlines recommendations on how to collect and report race and ethnicity data in a standardized format. At a minimum, the FDA recommends that study participants be offered the choice of self-reporting race as American Indian or Alaskan Native, Asian, Black, Native Hawaiian or Other Pacific Islander, and/or White and offered the choice of Hispanic or Latino or not Hispanic or Latino as options for reporting ethnicity. These categories mirror the options offered in the US Census.

Another limitation includes the reference point of our data. We chose to use the 2010 US Census data to analyze studies performed between 2004 and 2020, which could change the determination of underrepresentation or overrepresentation of racial and ethnic groups. However, the US Census is performed and available on a decennial basis, meaning this limitation is unavoidable. Further, as per 2020 Census data, the US population grew more diverse between 2010 and 2020, meaning it is possible that underrepresentation of racial or ethnic groups in our study would be underestimated. To this extent, clinical trial recruiters will need to remain diligent in representing the diversity of the US population.

While our study evaluates RCT demographic data compared to US Census data, we did not statistically adjust for populations in which retinal vascular diseases are more common. Several studies4,48,49 have found that Black individuals and Latino individuals were more likely to experience diabetic retinopathy and associated complications compared with White individuals. Thus, our study likely underestimates the degree of underrepresentation among these groups in the epidemiological framework of retinal vascular diseases in the US. Clinical trial design must often strike a balance between appropriately representing population demographic characteristics and intentionally representing populations experiencing a greater burden of disease. To this extent, clinical trial investigators might consider performing power and sample size calculations for enabling subgroup analysis, particularly for minority groups that are known to have disproportionate burdens of a given condition. This would likely necessitate advance planning in trial design as well as logistical considerations such as enrollment time, funding required, and total study participant recruitment.

Additional studies to identify recruitment barriers for underrepresented racial and ethnic minority groups will need to be performed, but the literature has already identified some barriers that should be considered in future studies by, for example, increasing racial and ethnic representation among investigators and working to rebuild trust with communities that may be fearful of health care researchers due in part to past institutional health care injustices and systemic racism. Sanjiv et al45 indicate that involving anthropologists may be helpful in rebuilding critical trust with these communities, aiding researchers in the direct engagement with the perceived needs of marginalized communities to further garner respect and reduce existing disparities. These challenges are not impossible to surmount, but they will need to be purposefully addressed with an integrated approach among health care professionals and the institutions within which they operate.

The evidence of underrepresentation of minority groups in trials begs another important question: is there a meaningful difference in response to treatment among racial and ethnic groups? One retrospective study found that, after receiving intravitreal bevacizumab for the treatment of DME, Black participants experienced a significantly lower likelihood of improvement in visual acuity.50 No other studies could be found that either validated this finding or evaluated the response of other minority groups to DME or RVO treatment. Future studies should focus on verifying the applicability of large RCT results to cohorts of sociodemographic minority group.

Conclusions

This study found that racial and ethnic demographic data of study participants in most RCTs for treatment of DME and RVO did not reflect that of the US population according to the 2010 US Census. Study participants identifying as White tended to be overrepresented in most RCTs. These findings support the need for more efforts to recruit underrepresented minority groups, which could improve the generalizability of RCT results and in turn help address health care disparities and better serve diverse populations.

Supplement.

eTable 1. Summary listing of the inclusion and exclusion reasons of DME and RVO trials, arranged chronologically by study completion year

eTable 2. Proportion of each racial demographic included in the diabetic macular edema clinical trials, compared to the expected 2010 United State Census

eTable 3. Proportion of each racial demographic included in the retinal vein occlusion clinical trials, compared to the expected 2010 United State Census

Click here for additional data file. (2.9MB, pdf)

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplement.

eTable 1. Summary listing of the inclusion and exclusion reasons of DME and RVO trials, arranged chronologically by study completion year

eTable 2. Proportion of each racial demographic included in the diabetic macular edema clinical trials, compared to the expected 2010 United State Census

eTable 3. Proportion of each racial demographic included in the retinal vein occlusion clinical trials, compared to the expected 2010 United State Census

Click here for additional data file. (2.9MB, pdf)

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