Gender, race, and ethnicity in lung cancer clinical trial participation: Analysis of 253,845 patients from 2002 to 2021

肺癌临床试验参与者的性别、种族和民族:对2002年至2021年253,845名患者的分析

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Abstract

BACKGROUND: Lung cancer remains the greatest cause of cancer-related death, and multiple large studies have identified persistent racial disparities in lung cancer outcomes. In this study, we used 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 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 the Student t test and χ(2) test. Trends were analyzed using Spearman testing in Python (VSCode). RESULTS: Rates of minority (ie, nonwhite) and female participation in US lung cancer clinical trials have increased significantly (P < .01) over the 20-year period from 2002 to 2021 but still do not represent parity with lung cancer incidence. Subset analysis by intervention offered did not show any significant differences in race, gender, or ethnic participation between studies that offered surgical intervention and those involving noninvasive interventions. National Institutes of Health-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 also increased significantly over the study period. 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.

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