Many patients with cancer do not have access to clinical trials based on where they live
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Key takeaways:
- Most U.S. counties do not have any active cancer clinical trials, and more than half do not have an oncologist.
- A higher percentage of nonmetropolitan than metropolitan counties had no trials.
Most counties in the United States do not have active cancer clinical trials, according to results of an ASCO analysis.
More than half of the country’s counties had neither a trial nor an oncologist within their border.
“We were expecting to see an uneven spread of trials across the country, and potentially one that clusters around large cancer centers,” Kelsey Kirkwood, MPH, associate director of data science at ASCO, told Healio. “That said, we were surprised by the number of counties without any active trials and with limited cancer portfolios that might lack suitable trials for patients with less-common cancers.”
Background and methods
More than 20% of people with cancer participate in clinical studies, according to study findings published this spring. Involvement in treatment trials more than doubled during the past 30 years; however, the participation rate for cancer treatment trials still stands at only 7.1%.
Many individuals are unable to participate due to personal or care-specific barriers, including location, Kirkwood said.
Prior research showed 55% of individuals with cancer did not have access to an appropriate clinical trial at their place of care, and 54% of counties in the U.S. did not have a hematologist or oncologist, according to study background.
Kirkwood and colleagues used ClinicalTrials.gov to investigate the location of phase 1 to phase 3 cancer treatment clinical trials conducted in the United States that enrolled adults from 2017 through 2022.
Researchers identified 6,710 trials active in 2022 (30% phase 1; 40% phase 2; 43% institution sponsored; 40% industry sponsored) that met their criteria.
Kirkwood and colleagues focused on individuals aged at least 55 years because 80% of new cancer diagnoses come from that demographic.
Quantity of trials per county and the characteristics of those areas — such as population and rurality — served as primary endpoints. Association between trial sites and social vulnerability, cancer incidence and mortality, as well as whether the region had an oncologist, served as secondary endpoints.
Results
The number of active trials increased from 4,791 in 2017 to 6,710 in 2022. However, the number of trial sites decreased from 1,847 to 1,836 over that period, with a low of 1,804 in 2020.
Researchers determined 70% of U.S. counties did not have an active trial in 2022. Those counties represented 74% of the country’s land area, and 19% of the nation’s 55-and-older population.
Additionally, 51% of counties — home to 9% of people aged at least 55 years — did not have a trial or an oncologist. Twenty percent of counties — home to 10% of the nation’s 55-and-older population — had an oncologist but no trial.
Conversely, 9% of counties — home to 48% of people aged at least 55 years — had at least 100 trials. One-quarter (26%) of individuals aged at least 55 years lived more than an hour drive away from a site with broad cancer trial offerings.
Kirkwood and colleagues also reported 86% of nonmetropolitan counties did not have a trial compared with 44% of metropolitan ones.
A higher percentage of counties with the highest cancer mortality rate than those with the lowest mortality rate had no trials (85% vs. 65%).
However, more counties in the top quartile of highest cancer incidence had at least one trial compared with counties in the other three quartiles (46% vs. 24%).
Researchers acknowledged study limitations, including the fact some trials are not registered with ClinicalTrials.gov.
Efforts to improve trial access
Earlier this year, ASCO made four recommendations to improve trial access.
One called for “fixing the improper use of the Food and Drug Administration’s Form 1572,” Kirkwood said. “This is the form that clinical trial investigators must complete to confirm they will follow FDA regulations, but many experts say the form’s unclear language leads to additional paperwork and trainings, which discourages investigators from allowing trial participants to receive basic care and testing closer to their homes.
“ASCO also called for trial sponsors and clinical research organizations to clarify their protocols, accommodate flexible approaches to enable local participation, and promote consistent data collection to streamline processes that enable decentralization,” Kirkwood added.
Researchers are exploring how these data can be used to recruit research sites in a range of geographic areas, with the goal to improve diversity so that trial participation better reflects the population of people seeking cancer treatment.
Kirkwood also emphasized the need for additional funding for federal research, as well.
“NIH- and NCI-funded research has played a role in every major advancement related to cancer prevention, early detection, treatment and survivorship over the last 50 years,” Kirkwood said. “And because of that investment in cancer research, more than 18 million cancer survivors are alive today in the United States. We continue to call on lawmakers to robustly fund these agencies to save even more lives.”
References:
- Kirkwood MK, et al. JCO Oncol Pract. 2024;doi:10.1200/OP.24.00261.
- Thota R, et al. J Clin Oncol. 2024;doi:10.1200/JCO.24.00961.
For more information:
Kelsey Kirkwood, MPH, can be reached at kelsey.kirkwood@asco.org.
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