Racial, Ethnic, and Gender Disparities in Diabetic Macular Edema Clinical Trials

Bowe, Theodore; Salabati, Mirataollah; Soares, Rebecca R.; Huang, Charles; Singh, Rishi P.; Khan, Mohammed; Williams, Basil K.; Sridhar, Jayanth; Chiang, Allen; Cohen, Michael N.; Klufas, Michael A.; Gupta, Omesh P.; Yonekawa, Yoshihiro; Xu, David; Kuriyan, Ajay E.

doi:10.1016/j.oret.2022.01.018

Cited by 14 publications

(11 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This continues a trend of poor recruitment from European trials when compared to North American trials, though neither have shown a temporal improvement in representation of ethnic minority participants [ 27 ]. There is also a large body of evidence which has identified previous racial and ethnic enrolment disparities in other types of medical research including trials on cancer, diabetes [ 20 , 28 ] and cardiovascular disease [ 29 ] over the last decade. This may be particularly concerning as the hospital population during the pandemic did not reflect ONS population statistics, with a higher proportion of inpatients from ethnic minority communities [ 30 ], in theory providing a larger pool for research teams to recruit from.…”

Section: Discussionmentioning

confidence: 99%

Ethnic minority representation in UK COVID-19 trials: systematic review and meta-analysis

Murali

Gumber

Jethwa

et al. 2023

BMC Med

View full text Add to dashboard Cite

Background The COVID-19 pandemic has highlighted health disparities affecting ethnic minority communities. There is growing concern about the lack of diversity in clinical trials. This study aimed to assess the representation of ethnic groups in UK-based COVID-19 randomised controlled trials (RCTs). Methods A systematic review and meta-analysis were undertaken. A search strategy was developed for MEDLINE (Ovid) and Google Scholar (1st January 2020–4th May 2022). Prospective COVID-19 RCTs for vaccines or therapeutics that reported UK data separately with a minimum of 50 participants were eligible. Search results were independently screened, and data extracted into proforma. Percentage of ethnic groups at all trial stages was mapped against Office of National Statistics (ONS) statistics. Post hoc DerSimonian-Laird random-effects meta-analysis of percentages and a meta-regression assessing recruitment over time were conducted. Due to the nature of the review question, risk of bias was not assessed. Data analysis was conducted in Stata v17.0. A protocol was registered (PROSPERO CRD42021244185). Results In total, 5319 articles were identified; 30 studies were included, with 118,912 participants. Enrolment to trials was the only stage consistently reported (17 trials). Meta-analysis showed significant heterogeneity across studies, in relation to census-expected proportions at study enrolment. All ethnic groups, apart from Other (1.7% [95% CI 1.1–2.8%] vs ONS 1%) were represented to a lesser extent than ONS statistics, most marked in Black (1% [0.6–1.5%] vs 3.3%) and Asian (5.8% [4.4–7.6%] vs 7.5%) groups, but also apparent in White (84.8% [81.6–87.5%] vs 86%) and Mixed 1.6% [1.2–2.1%] vs 2.2%) groups. Meta-regression showed recruitment of Black participants increased over time (p = 0.009). Conclusions Asian, Black and Mixed ethnic groups are under-represented or incorrectly classified in UK COVID-19 RCTs. Reporting by ethnicity lacks consistency and transparency. Under-representation in clinical trials occurs at multiple levels and requires complex solutions, which should be considered throughout trial conduct. These findings may not apply outside of the UK setting.

show abstract

Section: Discussionmentioning

confidence: 99%

Ethnic minority representation in UK COVID-19 trials: systematic review and meta-analysis

Murali

Gumber

Jethwa

et al. 2023

BMC Med

View full text Add to dashboard Cite

show abstract

“…The risk of decreased generalizability from clinical trials because of enrollment of nonrepresentative participant groups has been well-documented. 14 Our study builds on this by providing data those support the concern that differential rates of LTFU during clinical trials may further jeopardize generalizability and decrease confidence in the results. Participants who are Hispanic or Black, have worse control of their diabetes mellitus, worse DR, and have worse presenting VA were more likely to be lost to follow-up, decreasing the generaliz-ability of the DRCR trials.…”

Section: Discussionmentioning

confidence: 81%

Characteristics of Participants in Diabetic Retinopathy Clinical Research Clinical Trials Who Were Lost to Follow up

Bowe,

Mahmoudzadeh,

Soares

et al. 2023

Retina

Self Cite

View full text Add to dashboard Cite

Purpose: Our study describes the racial/ethnic composition and the broad health status/severity of disease of the cohorts of Diabetic Retinopathy Clinical Research (DRCR) clinical trials and compares the rates of non-completion of the trial to the first data report (lost to follow up (LTFU)). Methods: This study is a retrospective cohort study of participants in Diabetic Retinopathy Clinical Research (DRCR) Retina Network clinical trials that met our inclusion criteria. The primary outcome was the lost to follow up rates and their associated risk factors. Results: Eight clinical trials with 3492 participants met our inclusion criteria. Participants who were LTFU were more likely younger, Hispanic or Black, Type 1 DM, worse baseline BCVA, higher HbA1c, higher BP, and had PDR (Diabetic Retinopathy Severity Score >66). Conclusions: Participants who were LTFU during DRCR clinical trials tended to be younger, Hispanic or Black, and have worse diabetes and hypertension. This study highlights the importance of ensuring a representative population is maintained through the end of the study period.

show abstract

“…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 . RCT populations in this article were compared to corresponding demographic characteristics as reported in the US Census instead of to treatment databases.…”

Section: Discussionmentioning

confidence: 99%

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

2022

View full text Add to dashboard Cite

ImportanceDiverse 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.ObjectiveTo 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 ParticipantsThis 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 MeasuresOverrepresentation, underrepresentation, or representation commensurate with 2010 US Census data in the racial and ethnic populations of RCTs of retinal vascular disease.ResultsIn 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 RelevanceThe 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.

show abstract

Racial, Ethnic, and Gender Disparities in Diabetic Macular Edema Clinical Trials

Cited by 14 publications

References 18 publications

Ethnic minority representation in UK COVID-19 trials: systematic review and meta-analysis

Ethnic minority representation in UK COVID-19 trials: systematic review and meta-analysis

Characteristics of Participants in Diabetic Retinopathy Clinical Research Clinical Trials Who Were Lost to Follow up

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

Contact Info

Product

Resources

About