Demographic Trends in NCI-sponsored Early-phase Clinical Trials (2000-2023): A Cohort Study

Area of Science:

• Oncology
• Clinical Trials
• Health Disparities

Background:

• Early phase clinical trials are crucial for cancer therapy evaluation.
• Demographic representation in clinical trials has historically been uneven.
• Understanding enrollment trends is key to improving equitable access.

Purpose of the Study:

• To analyze demographic trends in National Cancer Institute (NCI)-sponsored early phase clinical trials from 2000-2023.
• To assess changes in patient representation across age, race, and ethnicity.
• To identify factors influencing trial enrollment and geographic accessibility.

Main Methods:

• Analysis of a large patient subset (N=16,609) from NCI Cancer Therapy Evaluation Program trials.
• Utilized three-year rolling averages and Joinpoint analysis for enrollment trends.
• Matched U.S. resident data to Census, geographic, and cancer incidence data.

Main Results:

• Increased enrollment observed in older adults (65-84 years) and Hispanic/Latino, Asian/Pacific Islander, and non-Hispanic Black patients.
• Participation for Hispanic/Latino and non-Hispanic Black patients remained below cancer incidence rates.
• Negligible enrollment noted for American Indian and Alaska Native populations.
• Improved representation and reduced travel distance after the 2014 Experimental Therapeutics Clinical Trials Network implementation.

Conclusions:

• While demographic representation in early phase cancer trials has improved, significant disparities persist.
• The Experimental Therapeutics Clinical Trials Network has positively impacted trial access and geographic reach.
• Further efforts are needed to ensure equitable participation across all patient populations, particularly underrepresented racial/ethnic groups.