Background <p>There is a lack of representation of most racial and ethnic populations in clinical trials in ophthalmology. In 2017, Roche/Genentech began to introduce a range of initiatives to improve the diversity of trial participants.</p> Objective <p>To assess whether company initiatives improved the racial/ethnic representation of participants in Roche/Genentech-sponsored phase 3 trials for the indications of neovascular age-related macular degeneration (nAMD)/geographic atrophy (GA), retinal vein occlusion (RVO), and diabetic retinopathy (DR)/diabetic macular oedema (DMO).</p> Methods <p>Proportions for each group were calculated and a Chi-Square test with continuity correction used to determine the statistical significance of difference between pre-2017 (2003–2017) and post-2017 (2018–2021) proportions (based on first-patient-in dates). Analyses were conducted for United States (US) sites only and for all global sites (including US).</p> Results <p>The noted significant improvements in enrolment were: in the global population, the proportion of Asians/Native Hawaiians/Pacific Islanders included in the trials for each indication increased significantly from pre-2017 to post-2017 (for nAMD/GA by eight-fold, for RVO by seven-fold, for DR/DMO by two-fold); for nAMD/GA trials, both the US and global populations had a significant (about four-fold) increase in the proportion of Black/African American participants from pre-2017 to post-2017, although the proportion was still very low (0.8%); for RVO trials, the proportion of Hispanic participants increased from pre-2017 to post-2017 both in the US and globally.</p> Conclusions <p>Company initiatives have improved the racial/ethnic diversity of participants in Roche/Genentech-sponsored phase 3 trials for ophthalmology. Roche/Genentech will continue efforts to enhance the representation of underserved populations in clinical trials.</p>

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Racial and ethnic diversity in ophthalmology: a meta-analysis of industry-sponsored phase 3 clinical trials from a single company

  • Adrienne W. Scott,
  • Jeremiah Brown Jr,
  • Alisa J. Prager,
  • Oluwatobi O. Idowu,
  • Steven Blotner,
  • Carlos Quezada-Ruiz,
  • Christopher Brittain,
  • Alicia Menezes

摘要

Background

There is a lack of representation of most racial and ethnic populations in clinical trials in ophthalmology. In 2017, Roche/Genentech began to introduce a range of initiatives to improve the diversity of trial participants.

Objective

To assess whether company initiatives improved the racial/ethnic representation of participants in Roche/Genentech-sponsored phase 3 trials for the indications of neovascular age-related macular degeneration (nAMD)/geographic atrophy (GA), retinal vein occlusion (RVO), and diabetic retinopathy (DR)/diabetic macular oedema (DMO).

Methods

Proportions for each group were calculated and a Chi-Square test with continuity correction used to determine the statistical significance of difference between pre-2017 (2003–2017) and post-2017 (2018–2021) proportions (based on first-patient-in dates). Analyses were conducted for United States (US) sites only and for all global sites (including US).

Results

The noted significant improvements in enrolment were: in the global population, the proportion of Asians/Native Hawaiians/Pacific Islanders included in the trials for each indication increased significantly from pre-2017 to post-2017 (for nAMD/GA by eight-fold, for RVO by seven-fold, for DR/DMO by two-fold); for nAMD/GA trials, both the US and global populations had a significant (about four-fold) increase in the proportion of Black/African American participants from pre-2017 to post-2017, although the proportion was still very low (0.8%); for RVO trials, the proportion of Hispanic participants increased from pre-2017 to post-2017 both in the US and globally.

Conclusions

Company initiatives have improved the racial/ethnic diversity of participants in Roche/Genentech-sponsored phase 3 trials for ophthalmology. Roche/Genentech will continue efforts to enhance the representation of underserved populations in clinical trials.