1123 Spine Disease Clinical Trial Representation: An Analysis of Racial and Ethnic Diversity

INTRODUCTION: Spine diseases pose a significant burden on individuals' health and quality of life, affecting millions worldwide. However, ensuring diverse representation in spine disease-related clinical trials, particularly concerning race and ethnicity, is essential for developing therapies that are effective and safe for all populations. METHODS: Detailed trial records from all US clinical trials registered in ClinicalTrials.gov relating to spine disease that were completed and included patients over the age of 18 were analyzed. Data for race, ethnicity, and gender were collected and compared to the US Census demographic estimates. Wilcoxon signed-rank tests were conducted to assess differences in the representation of minority and women participants compared to the overall trial population. RESULTS: 191 clinical trials met our inclusion criteria. From this cohort, we found that only 48.69% of trials reported race and 24.61% reported ethnicity. The only races that had at least 1 participant in most of the studies are Asian (74.47%), Black (75.53%), and White (98.94%). Hispanics (85.96%) and non-Hispanics (87.71%) were reported in a majority of the studies. Many participants were White (87.78%), which exceeded the US Census estimate of White representation (75.5%, p<0.05). Asian, Native Hawaiian and Pacific Islander, Black, and Hispanic were significantly underrepresented (p<0.05). For gender, women were in most studies and equally represented to male enrollment (p=0.21). CONCLUSIONS: These results are a clear indication of how minorities in spine disease-related clinical trials remain underrepresented relative to the US population even after the Revitalization Act of 1993. For this reason, greater diversity is required for clinical trial enrollment to ensure effective treatment for spinal pathology among all races and ethnicities.