DEC 30, 2022
Over the last two decades, the number of female lead clinical trial investigators has remained static and lower than expected, considering improvements in female representation among practicing ophthalmologists.
The authors searched ClinicalTrials.gov to assess female representation among lead investigators in all ophthalmology clinical trials taking place in the United States from 2001 to 2021 and analyzed factors that may be associated with gender differences.
Of 276 clinical trials that met the inclusion criteria, 20% listed a lead female author and 80% listed a lead male author, with no significant change in the trend for lead female authors during the study period. Males and females showed similar patterns of distribution across subspecialities. Analysis of factors such as clinical trial phase, geographic location, and treatment modality revealed no significant gender associations. However, practice setting (P = 0.04) and industry funding (P = 0.012) were significant, with 79% of female lead authors in university-based practices and male lead authors more likely to receive funding than females (70% vs 45%).
Listing of clinical trials on ClinicalTrials.gov was not required prior to 2007, so older trials may have been underrepresented in this cohort. The identification of the lead investigator may also have been erroneously attributed to the corresponding author (first author) in some cases, since the lead author may have been positioned elsewhere in the list of authors.
The proportion of female lead investigators in clinical trials remains below the estimates of females practicing ophthalmology, but the number of female ophthalmology trainees is rising. Awareness of the lack of proportional representation, especially within the factors of practice setting and industry funding, is important to promote continued improvements in the number and percentage of female ophthalmologists leading clinical trials.
Financial disclosures: Dr. Shriji Patel discloses financial relationships with Alcon Laboratories (Grant Support); Genentech (Advisory Board); Eyepoint (Advisory Board).