Health Disparities
Evaluation of participation in non-small cell lung cancer clinical trials in the US by race/ethnicity Meghann Wheeler* Meghann Wheeler Shama Karanth Hyung-Suk Yoon Joel Divaker Jae Jeong Yang Mindaugas Rackauskas Hiren J Mehta Dejana Braithwaite
Introduction: Despite efforts by organizations such as the NIH to increase diversity in clinical trial enrollment, significant racial/ethnic disparities remain. Given the significant disparities in NSCLC treatment and outcomes, improving diversity in lung cancer trials is of critical importance. Therefore, we sought to evaluate the distribution of racial/ethnic minority enrollment in NSCLC clinical trials using data from ClinicalTrials.gov.
Methods: We queried ClinicalTrials.gov for trials with the following restrictions: condition or disease: NSCLC; country: US; start date: on or after January 1, 2010 and before December 31, 2019; study type: interventional trials; study status: completed with results. We then extracted relevant trial characteristics and the number of participants by race and Hispanic origin from ClinicalTrials.gov or linked published results. Annual NSCLC incidence data was obtained from SEER*Stat 22 registries for each racial/ethnic group for the corresponding study years. A two-sample test for equality of proportions with continuity correction was applied to assess differences between incidence and trial participation. All data was analyzed in R.
Results: A total of 147 studies were included in the final analysis. Of the total 28,540 participants, 79.6% were White, 3.0% were Black, 10.4% were Asian or Pacific Islander, and 3.4% were Hispanic. Most participants were enrolled in trials that were phase 3 (63.8%), industry-sponsored (93.9%), and open-label (67.7%). When comparing trial participation to annual incidence data, we found overrepresentation among White participants (Difference: 5.8%) and underrepresentation among Black (Difference: -7.9%) and Hispanic participants (Difference: -3.2%).
Conclusion: There is persistent underrepresentation in NSCLC clinical trials among Black and Hispanic patients. Improving diversity in clinical trial accrual is critical to reducing health disparities and advancing the field of precision medicine.