Introduction: Participation in neuro-oncology clinical trials has been independently associated with improved outcomes. However, previous reports have identified a significant underrepresentation of racial and ethnic non-majority populations in these trials. To address this concern, the U.S. FDA issued strong recommendations in 2016 for reporting race in clinical trials. Here, we assess the effect of these recommendations on trends in race reporting and racial/ethnic diversity of neuro-oncology trials.
Methods: Trials were identified using the National Institutes of Health (NIH) Clinical Trials database with the following search criteria: Condition/Disease = “Brain and Central Nervous System Tumors” AND Date = 1/1/2000 to 3/1/2024. Trials that did not include patients with CNS malignancies, have available results, or report race or ethnicity were excluded.
Results: There were 10,384 participants in the 162 trials analyzed. Trials reporting results before 2016 were more likely to report race (81% pre-2016 vs 50% post-2016, p< 0.00001).The percentage of participants self-identifying as White was decreased in pre- versus post-2016 trials (81.3% before 2016 vs 75.3% after 2016, p< 0.0001), while the percentage of participants identifying as Asian increased (5.5% before 2016 vs 13.7% after 2016, p< 0.0001). In all trials reporting race, 77.5% were White (n=8056), 12.0% Asian (n=1139), 5.2% Black (n=540), 0.32% Native Hawaiian/Other Pacific Islander (n=33), 0.42% more than one race (n = 44), and 5.5% reported as Other (n = 572). Among patients that participated in clinical trials that reported ethnicity, 78.3% (n=6472) were non-Hispanic, 7.5% (n=622) were Hispanic, and 14.2% (n=1172) were listed as unknown.
Conclusion : Underrepresentation of racial and ethnic minority groups persists in neuro-oncology clinical trials. Since the FDA’s recommendation to improve race reporting in 2016, race reporting in neuro-oncology clinical trials has decreased, while the proportion of trial participants self-identifying as white has decreased. Further studies should identify factors contributing to decreased reporting of race and identify strategies to increase diversity in neuro-oncology clinical trials.
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