Demographic Trends in NCI-Sponsored Early Phase Clinical trials (2000–2023): A Cohort Study

Abstract We analyzed demographic trends among patients enrolled in National Cancer Institute Cancer Therapy Evaluation Program-sponsored early phase clinical trials in 2000–2023. Using a large patient subset (N = 16,609; 15,308 U.S. residents), we assessed enrollment trends via three-year rolling averages and Joinpoint analysis. U.S. residents were matched to Census demographics, rurality, geographic, and poverty data by ZIP code, and Surveillance, Epidemiology, and End Results 2022 cancer incidence rates. Enrollment increased among patients aged 65-74 (24.6% to 32.3%) and 75-84 (6.2% to 12.4%), and Hispanic/Latino (4.5% to 7.7%), Asian/Pacific Islander (2.2% to 4.4%), and non-Hispanic Black patients (6.1% to 7.2%). However, participation remained below cancer incidence rates for Hispanic/Latino and non-Hispanic Black patients, and was negligible among American Indian and Alaska Native populations. Representation improved significantly following the 2014 implementation of the Experimental Therapeutics Clinical trials Network, accompanied by a reduction in the average distance between patients' residences and enrolling institutions.