Gender, Race, and Ethnicity in Lung Cancer Clinical Trial Participation: Analysis of 253,845 Patients From 2002 - 2021.

Objective: Lung cancer remains the largest cause of cancer-related death, and multiple large studies have identified persistent racial disparities in lung cancer outcomes. In this study, we utilize public recording of lung cancer data on clinicaltrials.gov to sample age, gender, racial, and ethnic characteristics of participants in lung cancer clinical trials.

Methods: Clinicaltrials.gov, a US federal government repository of clinical trials was queried for the term "lung cancer" and several other related terms. A list of all studies matching these criteria was generated and information regarding age, gender, ethnicity, and racial breakdown of participants was analyzed. Studies that did not report results to clinicaltrials.gov or had at least one non-US site were excluded. Hypothesis testing was performed with Student's T-test and Chi-squared testing. Trends were analyzed using Spearman testing in Python (VS Code, Microsoft, Redmond, WA 2023) RESULTS: Rates of minority (non-white) and female participation in US lung cancer clinical trials have exhibited a significant increase (p<0.01) over the last 20 years (2002-2021, Figures 1) but still do not represent parity with lung cancer incidence. Subset analysis by offered intervention did not show a significant difference between studies that offered surgical or non-invasive intervention in race, gender, or ethnic participation. NIH-funded studies do not appear to have recruited any Hispanic participants as assessed by reporting on clinicaltrials.gov. The rates of race and ethnicity reporting have also significantly increased over the last 20 years (Figure 1C).

Conclusions: Our data demonstrate that there are persistent but improving racial and ethnic disparities in lung cancer clinical trials. Limitations of this study include poor reporting of results on clinicaltrials.gov. These findings demonstrate significant progress in the recruitment of minority participation, but also identify a significant role for policy changes to align participation with lung cancer incidence.