TOPLINE:

Geographic and socioeconomic characteristics are almost never reported in randomized cancer clinical trial publications, with no trials reporting rurality, income, or area-level deprivation among 441 US-based trials published from 2020 to 2025. In contrast, reporting of age and sex was nearly universal. Also, race and ethnicity reporting increased from approximately 62% in 2020 to more than 93% in 2025.

METHODOLOGY:

• Patients from rural areas demonstrate worse outcomes, and area-level measures of socioeconomic deprivation are associated with worse cancer outcomes in population studies and even among patients receiving protocol-directed care. The extent to which geographic and socioeconomic characteristics are reported in primary cancer clinical trial publications is unknown.
• Researchers conducted a systematic review of 441 US-based randomized phase 2 or phase 3 cancer treatment trials published in seven high-impact journals (The New England Journal of Medicine, Journal of Clinical Oncology, JAMA, JAMA Oncology, The Lancet, The Lancet Oncology, and Annals of Oncology) from 2020 through 2025.
• The analysis included manual abstraction of reporting frequencies for 15 geographic, socioeconomic, and demographic variables: rurality, area-level deprivation, insurance status, income, education, age, sex, and eight race and ethnicity categories (American Indian and Alaskan Native, Asian, Black, Hispanic, Native Hawaiian or other Pacific Islander, White, multiple races, or other).
• The primary outcome was the proportion of trials reporting each characteristic. Temporal trends were assessed using logistic regression models for binary outcomes, and negative binomial regression was used to evaluate the number of reported race and ethnicity categories by sponsor type, time period, and their interaction.
• A validation sample of 20 randomly selected studies demonstrated 99.7% concordance (299 of 300 data items) in item-level abstraction reliability.

TAKEAWAY:

• Reporting of any race or ethnicity category increased from 65.7% (94 of 143 trials) before 2022 to 90.9% (271 of 298 trials) during or after 2022, representing more than a fivefold increase in the odds (odds ratio, 5.23).
• Federally or academically sponsored trials reported 19% more race and ethnicity categories than industry-sponsored trials (incidence rate ratio [IRR], 1.19). Trials published during or after 2022 reported 64% more categories than earlier trials (IRR, 1.64).
• Among the 441 trials reviewed, age was reported in 100% of trials and sex in 99.8% (440 trials), whereas White race was reported in 80.7% (356 trials), Asian race in 74.8% (330 trials), and Black race in 72.6% (320 trials).
• No trials reported participant rurality, area-level deprivation, or income. Only two trials (0.5%) reported education, and one trial (0.2%) reported insurance status, with all three of these being federally sponsored cooperative group trials.

IN PRACTICE:

“Geographic and socioeconomic characteristics were rarely reported despite increasing attention to social determinants of health. Limited reporting of these characteristics may constrain assessment of trial generalizability and interpretation across diverse populations and care settings,” wrote the authors of the study.

SOURCE:

The study was led by Joseph M. Unger, PhD, Fred Hutchinson Cancer Center in Seattle. It was published online on June 23 in JAMA Network Open.

LIMITATIONS:

The review focused on primary trial publications from high-impact journals, which may not generalize to reporting norms in broader oncology research. The focus on reporting practices in primary trial publications does not preclude the possibility that some variables may have been collected and reported elsewhere, such as trial registries or regulatory submissions. The review was conducted by a single investigator, which may introduce potential for misclassification despite prespecified criteria and high validation concordance. Initial screening was AI-assisted, which may introduce study-level misclassification, although this approach is consistent with PRISMA guidance. Temporal analyses reflected associations with publication year and could not establish causal links between regulatory guidance or advocacy efforts and changes in reporting practices. The analysis was restricted to US-based randomized cancer treatment trials, which may limit generalizability to nonrandomized studies and trials conducted exclusively outside the US.

DISCLOSURES:

Arnold Ventures provided funding support for this study. It had no involvement in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. Unger disclosed receiving personal fees from Lilly and AstraZeneca outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.