Uneven global and racial representation in major orthopaedic clinical trials: Trends over a decade.

Background: The presence of geographic and demographic disparities in randomized controlled trials (RCTs) may affect the external validity of trials. While some studies have addressed racial or ethnic disparities, they have been limited to a certain region, and there is limited information about the global representation in orthopaedic research. Methods: RCTs published in major medical and orthopaedic journals from 2010 to 2019 were identified. After screening 6961 articles, 1769 trials enrolling 323,506 patients were included. The details of individual trials such as the country of origin, the proportion of women, and the proportion of different racial groups were recorded. Factors associated with reporting and representation of specific demographic groups, and annual changes were assessed. Results: Majority of the trials were from were from United States (US) (N = 380, 21.5%). US (30.7%, N = 99,356), United Kingdom (15.7%, N = 50,691) and Canada (8.3%, N = 26,890) accounted for majority of the enrolled patients. 59.1% of the patients were women. Among US trials reporting race, 81.2% were White, and 9.9% were African American. There was no significant variation in the global distribution (p = 0.056), percentage of women (p = 0.811), or percentage of Whites (p = 0.389) over the years. Conclusion: The top three countries contributed to about 55% of the enrolled patients, whereas they contributed to only 6% of the world population. Overall, women appeared to be adequately represented in the trials, while racial minorities were underrepresented. There has not been any considerable improvement in the representation of developing regions or minorities over the last decade.