Racial and Ethnic Disparities in Primary Open-Angle Glaucoma Clinical Trials

Abstract

IMPORTANCEThe disease burden for primary open-angle glaucoma (POAG) is highest among racial/ethnic minority groups, particularly Black individuals. The prevalence of POAG worldwide is projected to increase from 52.7 million in 2020 to 79.8 million in 2040, a 51.4% increase attributed mainly to Asian and African individuals. Given this increase, key stakeholders need to pay particular attention to creating a diverse study population in POAG clinical trials. OBJECTIVE To assess the prevalence of racial/ethnic minorities in POAG clinical research trials compared with White individuals. DATA SOURCES This meta-analysis consisted of publicly available POAG clinical trials using ClinicalTrials.gov, PubMed, and Drugs@FDA from 1994 to 2019. STUDY SELECTION Randomized clinical trials that reported on interventions for POAG and included demographic subgroups including sex and race/ethnicity. DATA EXTRACTION AND SYNTHESIS Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, 2 independent reviewers extracted study-level data for a random-effects meta-analysis. A third person served as the tiebreaker on study selection. Microsoft Excel 2016 (Microsoft Corporation) and SAS, version 9.4 (SAS Institute) were used for data collection and analyses. MAIN OUTCOMES AND MEASURESThe primary outcomes were the prevalence of each demographic subgroup (White, Black, Hispanic/Latino, other race/ethnicity groups, and female or male) in each trial according to the trial start year, study region, and study sponsor. Participation rates are expressed as percentages.RESULTS A total of 105 clinical trials were included in the meta-analysis, including 33 428 POAG clinical trial participants (18 404 women [55.1%]). Overall, 70.7% were White patients, 16.8% were Black patients, 3.4% were Hispanic/Latino patients, and 9.1% were individuals of other races/ ethnicities, including Asian, Native Hawaiian or Pacific Islander, American Indian or Alaska Native, and unreported as defined by the US Census. The mean (SD) numbers of participants by race/ethnicity were 236.5 (208.2) for White, 58.4 (70.0) for Black, 29.9 (71.1) for Hispanic/Latino, and 31.1 (94.3) for other race/ethnicity. According to the test for heterogeneity using the Cochrane Risk of Bias tool, the I 2 statistic was 98%, indicating high heterogeneity of outcomes in the included trials. A multiple linear regression analysis was performed to assess any trend and significance between participation by Black individuals and the year the study started, the region in which the study took place, and the study sponsor. There was no significant increase of Black participant enrollment from 1994 to 2019 (r 2 = 0.11; P = .17) and no significant association between Black participant enrollment and clinical trial (continued) Key Points Question What is the prevalence of participants from racial/ethnic minority groups compared with White individuals in primary open-angle glaucoma (POAG) clinical trials? Findings In this meta-analysis of 33 428 POAG clinical trial...

Reflection on Black and Ethnic Minority Participation in Clinical Trials

“…Pharmaceutical companies run on achieving the financial goals of their shareholders. As a result, they may be more inclined to recruit a homogenous trial cohort and choose investigation sites with higher enrolment, which may not necessarily serve large numbers of patients from ethnic minority groups [23].…”

PRIMARY OPEN ANGLE GLAUCOMA: MECHANISMS OF PATHOGENESIS AND GENETIC PREDISPOSITION. Review

“…Медична та соціальна значущість проблеми У світі налічується понад 60 мільйонів хворих на глаукому, 20 % з яких мають невиліковну стадію хвороби [46]. До 2040 року прогнозується збільшення кількості хворих на глаукому до 112 мільйонів, при цьому на первинну відкритокутову глаукому (ПВКГ) буде припадати 75 % випадків [4,5,65]. За уточненими даними, загальна популяція людей, які страждають на ПВКГ, у світі в 2020 році становила 68,56 млн осіб, більше 53 % Maidenko K.M.…”

Assessing Multiple Factors Affecting Minority Participation in Clinical Trials: Development of the Clinical Trials Participation Barriers Survey

“…Likewise, Hispanics make up 7.6% of research participants [ 3 ]. A meta-analysis analyzing the prevalence of participants from racial/ethnic minorities groups compared to White individuals in open-angle glaucoma clinical trials reveals that proportions of Black participants did not significantly increase from 1994 to 2019 [ 4 ]. Lower numbers of minority participants are attributed to historical events involving minorities.…”