Diversity & Inclusion

Diversity & Inclusion

Diversity & Inclusion

Diversity in Ophthalmic Clinical Trials

Traditionally, clinical trial recruitment has employed rationales of limited heterogenicity and interindividual variability to establish consistent short-term results; however, diversity and inclusion in ophthalmic clinical trials serve several purposes1:

  • It gives researchers more information on how new treatments may affect patients of color or those of different ethnicities and backgrounds2
  • It provides access to treatments to a wider range of people. These treatments have the potential to improve vision or reduce or prevent eye disease2
  • Participation in the trials from diverse groups gives broader data on treatment outcomes2
  • More diverse clinical trial participation helps reduce care disparities within ophthalmology2

An analysis of participation in clinical trials from around the globe completed by the US Food and Drug Administration (FDA) in 2020 found that among nearly 292,537 participants, 76% were White, underrepresenting the diversity of the world.1 “Data for global populations are lacking, and current guidelines and clinical decisions are based on insufficiently diverse trials and studies,” according to A. Sharma and L. Palaniappan.1

A similar analysis of ClinicalTrials.gov trial enrollees from 2000 to 2020 found that 79.7% of participants were White and 10% were Black, with much smaller percentages for other minority groups.3 Of the 20,692 trials in the analysis, only 43% reported race and ethnicity data.3

Within ophthalmology specifically, the lack of diversity within clinical trials also appears to be an overarching trend, based on the following studies:

  • An analysis of 25 National Institutes of Health (NIH)-sponsored and industry-sponsored trials for diabetic retinopathy and diabetic macular edema (DME) found that Black patients were under-represented by a 3.0 disparity in NIH studies and by a 4.5-fold disparity in industry trials for DME. Among diabetic retinopathy trials, researchers found a 2.1-fold disparity compared with disease burden4
  • Research from Kaakour and coauthors found similar discrepancies when analyzing 23 randomized controlled trials related to DME and retinal vein occlusion.5 Their research compared racial/ethnic makeup for the trial participants compared with the U.S. 2010 Census Bureau results and found that White participants were most frequently overrepresented, while Hispanic participants were most frequently underrepresented.5 “The representation gap for Hispanic/Latino participants is particularly concerning, given the burden of diabetes and hypertension in this community and the fact that this is the fastest-growing demographic subset in the US,” writes Sally L. Baxter, MD, MSC, in a commentary on the work from Kaakour and coauthors5,6
  • An analysis of race, ethnicity, and sex reporting for ophthalmology clinical trials from 1997 to 2022 found that only 43.6% provided this type of demographic information7
  • A cohort study examining 20 years of data from participants in age-related macular degeneration (AMD), open-angle glaucoma (OAG), and diabetic retinopathy trials found that Black, Hispanic or Latino, and other non-White participants were underrepresented.8 The trials included in the study were those that led to FDA drug approvals. While there was some improvement in representation between 2000 and 2020, the researchers concluded that more diversity is needed. If the current trends remain, there could be a continued overrepresentation of White participants by 2050, particularly in AMD trials.8
  • A study reviewing trials supportive of nine approved ophthalmological New Molecular Entities (NMEs) from 2006-2016 across a variety of eye diseases revealed significant enrollment variation across the trials, with 1%-15% Black participation and 2%-18% Hispanic participation.9
  • Racial and ethnic minority groups had a low participation rate in primary OAG clinical trials, according to a meta-analysis of clinical trials taking place from 1994 to 2019.10 Among the 105 trials with a total 33,428 participants, 70.7% were White, 16.8% were Black, 3.4% were Hispanic/Latino, and 9.1% were from other races/ethnicities. This imbalance exists despite the fact that primary OAG is most likely to affect Black individuals.
  • Geographical access is a barrier to trial access. Outside of the Northeastern United States, there was a higher travel burden associated with clinical trial sites for diabetic eye disease, according to researchers in a cross-sectional, retrospective study published in 2021.11 Geographical access to trials can have an effect on participant diversity.

Factors Affecting Clinical Trial Participation

There may be several reasons why clinical trials within ophthalmology and medicine in general have had more underrepresentation:6

  • Less recruitment among underrepresented minorities
  • Linguistic barriers
  • Cultural barriers
  • Structural distrust toward the health system
  • Difficulties accessing health services
  • Geographic barriers11

Improving Diversity in Clinical Trials: Implications for Ophthalmologists

Increasing diversity within ophthalmic clinical trials, including those within the retina subspecialty, has various underlying factors that need to be addressed to foster trust, enhance awareness, and facilitate participation. Efforts on the individual and collective level can do several things to improve diversity within clinical trials.

On the collective level, the American Academy of Ophthalmology (AAO) has established a task force focused on health equity in eye care. This task force takes a closer look at topics, such as the social determinants of health and medical care, access to care, and care outcomes. The AAO is also committed to developing meaningful patient and provider resources to help address this need for greater diversity, equity, and inclusion.12

Additionally, both pharmaceutical companies and the FDA are making efforts to focus on inclusion within clinical trials for all specialties. In its November 2020 “Enhancing the Diversity of Clinical Trial Populations” document, the FDA suggested several ways that clinical trials can increase diversity and inclusion.13 Some of its recommendations, along with recommendations from other sources, include:

  • Using more inclusive strategies for trial outreach
  • Working with community members on trial design to pinpoint where trials may discourage participation, so changes can be made to modify those areas
  • Using clinical trial sites located in racially and ethnically diverse areas
  • Holding frequent recruitment events, including evenings and weekends
  • Considering the use of online and social media recruitment strategies
  • Involving anthropologists to help reach communities with systemic distrust due to previous health-related injustice4
  • Recruiting a more diverse staff; research from Bains et al. found that trial participation increased when patients were approached by an ophthalmic staff member of the same race or ethnicity14
  • Enhancing health literacy and encouraging trial participation for individuals with limited English comprehension by translating educational and trial resources, as well as related documents (including informed consent), into native languages of community patients.13,15

Although studies such as Yu et al.16 have shown some narrowing of disparities and racial/ethnicity reporting in ophthalmic trial underrepresentation, continued efforts for engagement with underrepresented groups to diversify trial composition are vital to ensure the quality and validity of trial results.5 Programs, such as the National Institute of Health’s All of Us bring focused efforts to increase diversity in clinical trials.6

References

  1. Sharma A, Palaniappan L. Improving diversity in medical research. Nat Rev Dis Primers. 2021;7:74. https://www.nature.com/articles/s41572-021-00316-8
  2. Younossi A, Sanhai W, Shh S, Chang C. Enhancing clinical trial diversity. November 11, 2021. https://www2.deloitte.com/us/en/insights/industry/life-sciences/lack-of-diversity-clinical-trials.html
  3. Turner BE, Steinberg JR, Weeks BT, Rodriguez F, Cullen MR. Race/ethnicity reporting and representation in US clinical trials: A cohort study. Lancet Reg Health Am. 2022;11:100252. https://www.sciencedirect.com/science/article/pii/S2667193X22000692
  4. Sanjiv N, Osathanugrah P, Harrell M, et al. Race and ethnic representation among clinical trials for diabetic retinopathy and diabetic macular edema within the United States: A review. J Natl Med Assoc. 2022;114:123-140. https://www.sciencedirect.com/science/article/abs/pii/S0027968421002340
  5. Kaakour AH, Hua HU, Rachitskaya A. Representation of race and ethnicity in randomized clinical trials of diabetic macular edema and retinal vein occlusion compared to 2010 US Census data. JAMA Ophthalmol. 2022;140:1096-1102. https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2797004
  6. Baxter SL. Representation matters—Diversity in clinical trials. JAMA Ophthalmol. 2022;140:1103‑1104. https://jamanetwork.com/journals/jamaophthalmology/article-abstract/2797007
  7. Montazeri F, Wang M, Atkuru A, Estrada MM, Liu YA, Emami-Naeini P. Racial, ethnic, and gender diversity in United States ophthalmology clinical trials. Ophthalmol Sci. 2024;4:100402. https://www.ophthalmologyscience.org/article/S2666-9145(23)00134-3/fulltext
  8. Berkowitz ST, Groth SL, Gangaputra S, Patel S. Racial/ethnic disparities in ophthalmology clinical trials resulting in US Food and Drug Administration clinical trials from 2000 to 2020. JAMA Ophthalmol. 2021;139:629-637. https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2778782
  9. Birnbaum FA. Gender and ethnicity of enrolled participants in US Food and Drug Administration (FDA) clinical trials for approved ophthalmological new molecular entities. J Natl Med Assoc. 2018;110:473-479. https://www.sciencedirect.com/science/article/abs/pii/S0027968416302036
  10. Allison K, Patel DG, Greene L. Racial and ethnic disparities in primary open-angle glaucoma clinical trials: A systemic review and meta-analysis. JAMA Netw Open. 2021;4:e218348. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2779939
  11. Soares RR, Parikh D, Shields CN, et al. Geographic access disparities to clinical trials in diabetic eye disease in the United States. Ophthalmol Retina. 2021;5:879-887. https://www.sciencedirect.com/science/article/abs/pii/S2468653020304875
  12. American Academy of Ophthalmology. Diversity, Equity, Inclusion, and Accessibility. https://www.aao.org/diversity-equity-and-inclusion
  13. US Food and Drug Administration. Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. November 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial
  14. Bains A, Osathanugrah P, Sanjiv N, et al. Diverse research teams and underrepresented groups in clinical studies. JAMA Ophthalmol. 2023;141:1037-1044. https://jamanetwork.com/journals/jamaophthalmology/article-abstract/2810430
  15. Coney JM. Racial bias in clinical trials: What you need to know. Retina Today. March 2021. https://retinatoday.com/articles/2021-mar/racial-bias-in-clinical-trials-what-you-need-to-know
  16. Yu AJ, Masalkhi M, Brown R, Chen B, Chhablani J. Racial and ethnic distribution in diabetic macular edema trials in the United States (2002-2021). Ophthalmol Retina. 2023;7:1035-1041.

All URLs accessed February 21, 2024

This activity is provided by Med Learning Group.
This activity is supported by an independent medical education grant from Regeneron Pharmaceuticals, Inc.

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