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.