Key Takeaways
- In 2020, only 3.6% of adult cancer patients in the US enrolled in therapeutic clinical trials
- From 2000-2017, the overall participation rate in NCI-sponsored trials was 2.5% among US cancer patients
- Pediatric cancer trial participation reached 70% for eligible patients in Children's Oncology Group studies in 2019
- Black patients comprised only 5% of participants in SWOG trials from 2010-2020 despite 13% cancer incidence
- Hispanic patients represented 4.2% in NCI trials 2010-2019, while comprising 19% of US population
- Asian Americans made up 2.1% of phase I-III trial participants in 2018
- Patients with annual income below $50,000 had 40% lower odds of trial participation
- Uninsured patients participated at 1.2% rate vs. 4.1% for privately insured in 2017 data
- Medicaid enrollees showed 2.3 times lower participation than Medicare patients in oncology trials
- 62% of US cancer centers are in urban areas, leading to 3x lower rural participation
- Travel distance >50 miles reduced enrollment by 35% in NCI Community Oncology Research Program
- In Appalachia, trial participation was 1.1% vs. national 3.4% average in 2018
- Adults over 65 years enrolled at 25% rate of those under 65 in phase III trials 2010-2020
- Women comprised 62% of breast cancer trial participants but only 38% in lung cancer trials in 2019
- Patients aged 18-39 had 1.8% participation vs. 4.2% for 40-64 in 2017 surveys
Cancer clinical trial participation is alarmingly low and suffers from significant inequities.
Age and Gender Differences
- Adults over 65 years enrolled at 25% rate of those under 65 in phase III trials 2010-2020
- Women comprised 62% of breast cancer trial participants but only 38% in lung cancer trials in 2019
- Patients aged 18-39 had 1.8% participation vs. 4.2% for 40-64 in 2017 surveys
- Men over 70 underrepresented by 40% in prostate cancer trials despite high incidence
- Pediatric trials saw 85% enrollment for ages 0-14 vs. 45% for adolescents 15-19 in 2022
- Elderly (75+): 12% of trial participants despite 40% diagnoses
- Gender imbalance in GI trials: 55% male vs. 45% female 2015-2020
- Young adults (18-39): 2.1% overall participation 2018
- Women underrepresented in bladder cancer trials by 25%
- Teens (15-19) accrual: 52% of COG targets in 2021
- 80+ year olds: 8% enrollment despite 25% diagnoses
- Males in breast cancer trials: 1.2% despite 1% incidence
- Children 0-4: 92% COG accrual 2020
- Females in pancreatic trials: 48% vs. 52% male 2016-2021
- AYA (15-39): 1.5% of all cancer trial slots 2019
- 65-74 age group: 32% of participants 2021
- Males dominate liver cancer trials 78%
- Infants <1 year: 88% enrollment in rare trials
- Gender parity improving: 51% female overall 2022
- Seniors 70+: comorbidity exclusion 42% cases
Age and Gender Differences Interpretation
General Participation Rates
- In 2020, only 3.6% of adult cancer patients in the US enrolled in therapeutic clinical trials
- From 2000-2017, the overall participation rate in NCI-sponsored trials was 2.5% among US cancer patients
- Pediatric cancer trial participation reached 70% for eligible patients in Children's Oncology Group studies in 2019
- In phase III cancer trials from 2011-2020, average accrual was 68% of target, taking 3.2 years on average
- US cancer clinical trial enrollment dropped to 1.8% during COVID-19 peak in 2020
- In 2021, NCI trials showed 28% enrollment from patients over 70, up from 20% in 2010
- Phase I trials had 5.2% participation rate among advanced cancer patients in 2018
- Community-based trials enrolled 1.9% vs. 5.1% academic centers in 2019
- Lung cancer trials averaged 512 participants per trial from 2015-2020
- Overall US adult oncology trial accrual was 27,000 patients annually pre-COVID
- Basket trials saw 4.1% enrollment rise 2017-2022
- Immunotherapy trials: 6.3% participation among eligible 2020
- 45% of trials failed to meet accrual in under 2 years 2019
- Precision medicine trials: 3.8% uptake in metastatic cancers
- Global trials: US contributes 60% of participants 2021 data
- Master protocols accelerated accrual by 12% in 2022
- CAR-T trials: 7.2% eligible participation 2021
- 32% trials amended targets due to slow accrual 2018
- Head/neck cancer: 2.9% participation rate 2020
- International collaboration boosted enrollment 25% per trial
- NCI MATCH trial: 4.5% screen-to-enroll success 2019
- PROACTIVE initiative raised community accrual 11%
- 58% phase II trials closed early for poor accrual 2020
- Leukemia trials: 8.4% pediatric participation 2021
- EU-US trials: 45% faster accrual than domestic
General Participation Rates Interpretation
Geographic and Access Issues
- 62% of US cancer centers are in urban areas, leading to 3x lower rural participation
- Travel distance >50 miles reduced enrollment by 35% in NCI Community Oncology Research Program
- In Appalachia, trial participation was 1.1% vs. national 3.4% average in 2018
- Telehealth interventions increased remote enrollment by 22% during 2020-2021
- Southern US states had 1.9% participation rate vs. 4.2% in Northeast in 2019 data
- Patients >100 miles from site: 42% non-enrollment rate
- Midwest rural enrollment: 1.4% vs. 3.9% urban 2017-2021
- Lack of local trials: 68% barrier in underserved areas 2020
- Mobile units boosted enrollment 18% in remote areas 2022 trial
- Western states participation: 2.8% vs. 1.7% in South 2019
- Frontier areas (low population density): 0.8% enrollment 2019
- Northeast urban: 5.1% vs. Southwest rural 1.2% 2021
- No trials within 75 miles for 25% rural patients
- Virtual screening raised enrollment 15% in 2022 pilots
- Pacific territories: <0.5% US trial participation 2018
- Travel burden >2 hours: 51% decline rate 2020
- Alaska Natives rural: 0.7% participation 2018
- Trial deserts in 15% US counties 2022 map
- Decentralized trials: 28% accrual improvement 2023 data
- Border states higher Hispanic enrollment 3.1%
Geographic and Access Issues Interpretation
Racial and Ethnic Disparities
- Black patients comprised only 5% of participants in SWOG trials from 2010-2020 despite 13% cancer incidence
- Hispanic patients represented 4.2% in NCI trials 2010-2019, while comprising 19% of US population
- Asian Americans made up 2.1% of phase I-III trial participants in 2018
- Native American/Alaska Native patients enrolled at 0.3% rate in cancer trials 2004-2016
- In breast cancer trials, Black women enrollment was 7.5% vs. 12.4% white women from 2011-2018
- African American men in prostate cancer trials: 8.2% enrollment despite 20% higher mortality
- Latinos in colorectal cancer trials: 3.7% vs. 11% incidence share 2012-2019
- South Asian subgroup in trials: 0.8% participation in 2020 meta-analysis
- American Indian patients in NCI trials: 0.2% from 2000-2018
- Black women in ovarian trials: 5.1% enrollment 2010-2020
- Whites: 80% of trial participants despite 75% cancer cases
- Pacific Islanders: 0.1% in NCI database 2010-2020
- Multiracial patients: 1.2% enrollment 2018
- Hispanic blacks: 0.4% in melanoma trials
- Asians in liver cancer: 15% enrollment matching incidence
- Recruitment strategies improved black enrollment by 14% 2021
- Non-Hispanic whites: 84% in CAR-T trials 2020
- Middle Eastern/North African: 0.6% reported 2019
- Enrollment disparities narrowed 2% yearly for Hispanics 2015-2020
- Blacks in MM trials: 4.8% 2012-2021
Racial and Ethnic Disparities Interpretation
Socioeconomic Factors
- Patients with annual income below $50,000 had 40% lower odds of trial participation
- Uninsured patients participated at 1.2% rate vs. 4.1% for privately insured in 2017 data
- Medicaid enrollees showed 2.3 times lower participation than Medicare patients in oncology trials
- Low education (high school or less) correlated with 55% reduced trial enrollment likelihood
- Rural patients had 28% lower enrollment rates than urban counterparts in 2015-2020 trials
- Household income <$30k: 52% less likely to enroll per 2016 study
- Public insurance holders: 1.5% participation vs. 3.8% private in 2020
- No high school diploma: 0.9% enrollment rate in surveys
- Cost concerns cited by 47% of low-SES decliners in 2019 poll
- Unemployment linked to 33% lower odds in multivariate analysis
- Poverty rate >20% counties: 1.6% participation
- College grads: 4.7x higher enrollment odds 2020
- Transportation costs deterred 39% low-income
- Blue-collar workers: 28% lower rate than white-collar
- Food insecurity linked to 22% drop in willingness
- Income $75k+: 5.1% participation 2017 survey
- VA patients: 3.2% enrollment higher than average
- Lost wages feared by 35% non-enrollees low-SES
- Graduate degree: 6.2% participation rate
- Housing instability: 19% barrier in qualitative study






