Patient-reported outcomes, race, and ethnicity in high-impact lung cancer clinical trials.

Abstract

e23015 Background: Lung cancer clinical trials enroll disproportionately low numbers of Black and Hispanic patients. Patient-reported outcomes (PRO) accurately assess adverse events and are also widely advocated for by patient groups but are not uniformly included in clinical trials. This study reports updated race/ethnicity enrollment and rate of PRO reporting in the highest-impact lung cancer trials. Methods: New England Journal of Medicine (NEJM), Journal of Clinical Oncology (JCO), and Lancet Oncology (LO) were systematically searched to identify clinical trials including patients with lung cancer published between 2020-2024. In the event of multiple publications, each study was included once, and the index publication date recorded. Chi-square tests were used to calculate statistical significance between groups and for trend, with p < .05 cutoff for significance. Results: 128 lung cancer trials were published in NEJM, JCO, and LO between 2020 and 2024. Across all trials, a total of 440 Black patients and 65 Hispanic patients were enrolled. 53% of studies specified the race of patients. 89% NEJM, 41% LO, and 47% JCO publications reported the race of participants (p < .05). Among trials that reported race, 1.8% of patients were Black and 61% were white. 10% of trials specified enrolling patients of Hispanic ethnicity; amongst these trials, Hispanic patients comprised 2.2% of participants. Reporting of race increased with advancing publication year (p < .05). The proportion reporting enrollment of least one Black or Hispanic patient also increased with advancing year, though this did not reach significance (p = .29 and p = .38, respectively). 63% included PRO collection in their protocol and 47% published a PRO. 74% of trials that collected PRO published the outcomes. 38% of PRO were published in the index publication and 62% in a secondary publication, 65% of which were peer-reviewed papers. 52% of trials investigating therapies that were for non-curative or palliative intent reported PRO; 29% of trials for curative-intent treatment reported PRO (p < .05). There was no increase in PRO reporting over time (p = .27). Conclusions: Race is under-reported, and Black patients are under-enrolled in high-impact lung cancer publications. Only 10% of trials specified Hispanic ethnicity, though this group of trials enrolled a proportion of Hispanic patients that approximated the relatively lower incidence of NSCLC in Hispanic patients. The minority of trials published PRO. Structured efforts should continue to encourage aligning trials with demographics and values of patients. PRO and reported race in NSCLC trials by publication year. Publication date n Published PRO (%) Reported race (%) % enrolling >/= 1 Black patient % enrolling >/= 1 Hispanic patient Black + Hispanic participants (%) <2020 14 79 35 22 0 1.2 2020 23 48 47 33 4 0.7 2021 15 53 43 30 0 0.6 2022 23 26 70 52 9 0.6 2023 27 37 73 42 11 1.8 2024 26 54 36 29 15 1.2