Ethnic disparities in clinical trials for FDA-approved drugs in lung cancer: A post-COVID era analysis (2020-2024).

Abstract

e13819 Background: In the post- COVID era, disparities in healthcare have become more apparent, highlighting the urgent need to address inequities in cancer research. Although lung cancer treatments have advanced, racial minorities are still underrepresented in clinical trials, raising concerns about fair access to new therapies. The pandemic further exacerbated challenges, specially access to health care and increased socioeconomical barriers, affecting disproportionately minority communities. This study evaluates racial representation in lung cancer clinical trials that lead to FDA approval in the post Covid Era compared to SEER incidence rates to identify gaps and address barriers to equitable participation. Methods: We analyzed racial demographics from twenty-two industry-sponsored lung cancer trials, from which only fifteen (68.18 %; NCT03703297, NCT03800134, NCT03456076, B7461006, NCT04025879, NCT03600883, NCT05060016, NCT04035486, NCT02409342, NCT03425643, NCT03785249, NCT03157128, NCT04487080, NCT04538664) included racial and ethnic data comprising 6694 participants. The observed racial distribution was compared against SEER incidence data for lung cancer. Expected counts were derived by normalizing SEER incidence rates to the total trial enrollment. A chi-square test was performed to assess statistical significance. Results: Among trial participants, 56.9% were White, 1.0 % were Black, 38.6 % were Asian and 0.04 % were Hispanic. In contrast, SEER data suggests and expected distribution of 24.45 % White, 23.19 % Black, 13.79 % Asian, and 11.83 % Hispanic. Chi-square analysis confirmed significant disparities across all racial groups (p < 0.001), with White (χ² = 44.82, p < 0.001), and Asian (χ² = 48.12, p < 0.001) participants overrepresented, while Black (χ² = 21.65, p < 0.001), and Hispanic (χ² = 12.18, p < 0.001) participants were underrepresented. These findings highlight the need to address inequities in lung cancer clinical trial participation. Some of the trials were international and domestic. Conclusions: Our findings demonstrate persistent racial and ethnic disparities in lung cancer clinical trials, with White and Asian participants significantly overrepresented while Black and Hispanic population remain underrepresented. This underrepresentation raises significant concerns about the applicability of trial results and the fair development of new lung cancer treatments. Moreover, inconsistencies in reporting race and ethnicity in trials highlight the urgent need to prioritize diversity in clinical research. Tackling these disparities requires immediate action, such as implementing targeted recruitment strategies and standardized reporting practices, to ensure clinical trials represent the diverse populations most impacted by lung cancer and provide equitable treatment outcomes for everyone.