Abstract
Background: To understand the changing trends in reporting of
race and sex as a demographic variable in phase III lung cancer clinical
trials published over the last 35 years.
Methods: A total of 426 articles reporting results of phase 3
lung cancer clinical trials published from 1984 to 2019 were identified
in PubMed. Statistical analysis on trends over time on percentage of
minority and female participation were performed.
Results: Only 137 (32.2%) of the 426 studies analyzed reported
race of participants. Among those studies, we found that the mean
participation rate of white participants was significantly higher
(82.65%) (p < 0.001). We found a decrease in African
American participants and an increase in Asian participants over time.
When looking at sex, we found that although the rate of male
participation (69.02%) was significantly higher than that of female
participation (30.98%), the female participation has improved with time
at a rate of 0.65% per year.
Conclusions: We found that the reporting and participation of
minority races continues to lag that of other demographic factors like
sex in phase III clinical trials in lung cancer. Especially in African
Americans, where the participation in lung cancer phase III clinical
trials has declined despite the rising incidence in lung cancer.
Keywords: Lung cancer, clinical trials, disparities, NIH
Revitalization Act, race, sex