INTRODUCTION: Traumatic brain injury (TBI) has higher mortality in minority populations, but these individuals are less likely to participate in TBI trials than non-minorities due to reasons ranging from historical abuse to socioeconomic status. Therefore, it is imperative barriers to minority inclusion in TBI trials are overcome. METHODS: 350 out of 592 TBI studies with published results were compared to the general population statistics on race/ethnicity and sex from the U.S. census and TBI statistics from the CDC. RESULTS: Trials with a completed status compared to withdrawn status were 128 times more likely to publish their findings. While sex was frequently reported (males- 68% of the study participants), the majority of studies did not report race/ethnicity. 9.9% of enrolled subjects are Black even though they represent 12.3% and 19% of TBI cases and mortalities, respectively. This same trend is seen in all other populations, except White people, who were found to be overrepresented in trials as 65.3% of participants are White even though they account for 63.1% and 52.0% of TBI cases and mortalities, respectively. Black patients were 1.9 more times likely to die from head injuries compared to White patients. The average number of days/sessions involved in TBI trials was 12 and the average trial duration was 6.3 years. 14 (29%) trials required phone calls for follow up visits and 14 trials specifically excluded non English speakers. CONCLUSION: The majority of TBI clinical trials reported sex, but not report race/ethnicity. Factors that may influence participation include trial duration and effort commitment. Our results demonstrate the need for demographic reporting to ensure the population being studied accurately reflects the population suffering from the burden of disease.
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