Racial, ethnic, sex, and age representation in clinical trials of radiopharmaceutical tumor therapy: a systematic review and meta-analysis

作者：Mingye Zhao, Yunlin Jiang, Taihang Shao, Wenxi Tang · 发表于：BMC Cancer · 年份：2025 · DOI：10.1186/s12885-025-14527-9 · 被引用次数：3 · 研究领域：Radiopharmaceutical Chemistry and Applications、Prostate Cancer Treatment and Research、Lung Cancer Research Studies

BACKGROUND: Radiopharmaceutical therapy (RPT) is an emerging precision oncology approach. However, disparities in racial, ethnic, gender, and age representation in RPT cancer clinical trials may limit trial generalizability and equity. This study aims to quantify demographic disparities in RPT cancer clinical trials compared to US population data and examine trends and trial characteristics associated with these disparities. METHODS: Systematic searches of PubMed, Web of Science (via MEDLINE), and ClinicalTrials.gov were conducted through November 2024. Population-based cancer data were obtained from the Surveillance, Epidemiology, and End Results (SEER) databases. All RPT clinical trials reporting age, race, ethnicity, or gender data and recruiting entirely in the US were included. Two reviewers independently extracted trial characteristics and demographic data. Enrollment incidence ratios (EIRs; < 1 indicates underrepresentation, > 1 indicates overrepresentation) were calculated for race, ethnicity, and gender, while median-age ratios (MRs; < 1 indicates younger trial participants compared to disease median diagnosis age) were used for age. Meta-analysis and meta-regression were performed to analyze disparities and trends over time. RESULTS: Among 116 trials (5317 patients), reporting rates were 36.21% for race, 22.41% for ethnicity, 98.04% for gender, and 95.69% for median age. White participants were overrepresented (EIR: 1.04, 95% CI: 1.01-1.07), while Black (EIR: 0.32, ...