Spine Disease Clinical Trial Representation: An Analysis of Racial, Ethnic, and Gender Diversity.

BACKGROUND AND

OBJECTIVES

Spine diseases significantly burden individuals' health and quality of life, affecting millions worldwide. Ensuring diverse representation in spine disease-related clinical trials, particularly concerning race, ethnicity, and gender, is essential for developing effective and safe therapies for all populations. The objective of this study was to analyze whether spine disease clinical trials have adequate representation.

METHODS

Detailed trial records from all US clinical trials (up to January 1, 2024) registered in ClinicalTrials.gov relating to spine disease that were completed, had results, and included participants aged older than 18 years were analyzed. Data for race, ethnicity, and gender were collected and compared with state Census demographic estimates. Trends in demographic reporting and representation of trials over time, how trial factors are correlated with these trends, and the type of trial interventions were analyzed.

RESULTS

One hundred and ninty-three clinical trials met our inclusion criteria. From this cohort, we found that only 48.19% of trials reported race and 30.05% reported ethnicity. Most participants were White (median: 93.43%), which exceeded the state Census estimate of White representation (median: 76.58%, Asymp. Sig. P < .001). Asian, Native Hawaiian, Pacific Islander, Black, and Hispanic participants were significantly under-represented (Asymp. Sig. P < .001). For gender, men were significantly under-represented between 2008 and 2016 (Asymp. Sig. P = .027) and over-represented between 2018 and 2022 ( P = .036).

CONCLUSION

These results indicate that racial and ethnic minorities in spine disease-related clinical trials remain under-represented relative to the US population even after the Revitalization Act of 1993, the Food and Drug Administration Amendments Act of 2007, Section 801, and the Final Rule policy. Furthermore, gender representation fluctuated after the enactment of the policies. For this reason, clinical trials should be more aware of having adequate representation during enrollment and more transparent in reporting race, ethnicity, and gender.