Abstract
Purpose :
Numerous studies have raised concerns that clinical trial cohorts are demographically different from the affected population. Data regarding the composition of ocular oncology clinical trials is lacking. In this cross-sectional study, we assessed the diversity in racial and ethnic, age, and gender representation of participants in global ocular oncology trials using public databases.
Methods :
Ocular oncology trials were identified from ClinicalTrials.gov, ClinicalTrialsRegister.eu, the European Organization for Research and Treatment of Cancer Clinical Trials Database, and the World Health Organization International Clinical Trials Registry Platform. Demographics including age, race, ethnicity, and gender were extracted. Single-nation trials were compared to national incidence data, with U.S. data sourced from the National Cancer Institute - Surveillance, Epidemiology, and End Results (SEER) database for chi-square analyses.
Results :
A total of 43 ocular oncology clinical trials were identified worldwide, with 32 (74.4%) studying uveal melanoma (UM), 10 (23.3%) studying retinoblastoma (Rb), and 1 (2.3%) studying conjunctival neoplasms. Fifteen (34.9%) trials involved trial sites in multiple countries, while 27 (62.8%) took place in a single nation. Among all trials, 25 (58.1%) had complete demographic information. Of these 25 trials, 17 were single-nation trials conducted in the U.S. and 8 were multi-institutional trials that involved at least one U.S. trial site. Of the 17 single-nation trials, 4 studied Rb and represented 66 patients, while 13 trials studying UM represented 419 patients and were able to be compared with the SEER database. UM trial demographics in the U.S. matched SEER data: White (98.3% [n = 209] vs. 97.7% [n = 5800]), Asian/Pacific Islander (0.4% [n = 3] vs. 0.8% [n = 45]), Black (0.5% [n = 2] vs. 0.7% [n = 43]), and American Indian/Alaskan American (0.0% [n = 0] vs 0.1% [n = 8]) (p = 0.68) with no significant gender or age differences compared to the affected population.
Conclusions :
Global ocular oncology trials lack comprehensive racial and ethnic data reporting. Consequently, enhancing this reporting globally is crucial to uncover and address disparities in these trials.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.