In a retrospective cohort study reported in JAMA Oncology, Green et al found that only 1% to 2% of Medicare fee-for-service beneficiaries aged ≥ 65 years with cancer were enrolled in interventional cancer clinical trials.
Study Details
The study assessed clinical trial participation among patients with Medicare fee-for-service insurance aged ≥ 65 years with cancer from January 2014 through June 2020. Claims data from Medicare fee-for-service were linked with ClinicalTrials.gov to determine trial participation through unique National Clinical Trial (NCT) identifiers. Proportions of patients with newly diagnosed or newly recurrent cancer in 2015 participating in an interventional clinical trial and receiving active cancer treatment from January 2014 to June 2020 were estimated.
Key Findings
Based on claims, 1,150,978 patients with Medicare fee-for-service insurance had newly diagnosed or newly recurrent cancer in 2015. Of these, 12,028 (1.0%) had a billing claim with an NCT identifier indicating enrollment in an interventional clinical trial between January 2014 and June 2020.
Among 429,343 patients receiving active cancer treatment in 2015, 8,360 (1.9%) had one or more billing claims with at least one NCT identifier corresponding to an interventional clinical trial. A total of 1,309 (0.3%) had billing claims with two or more unique NCT identifiers, indicating participation in multiple interventional trials over the study period.
Compared with patients not enrolled in interventional trials, those enrolled in such trials were less likely to be Black (5.8% of trial participants vs 8.0% of those not participating), more likely to be male (55.3% vs 49.5%), more likely to be younger than 75 years (79.6% vs 59.2%), more likely to reside in a metropolitan area (87.2% vs 81.7%) and in the Northeast (24.5% vs 18.3%), more likely to reside in zip codes with a median income greater than $60,430 (57.0% vs 47.4%), and more likely to have a Charlson Comorbidity Index score of 0 (69.2% vs 51.6%).
The investigators concluded: “Findings of this cohort study show that clinical trial enrollment among older adult patients with cancer remains low, with only 1.0% to 1.9% of patients with newly diagnosed or recurrent cancer in 2015 participating in an interventional cancer clinical trial as measured by the presence of NCT identifiers in Medicare claims. These data provide a contemporary estimate of trial enrollment, persistent disparities in trial participation, and only limited progress in trial access over the past 2 decades.”
Angela K. Green, MD, MSc, of Memorial Sloan Kettering Cancer Center, is the corresponding author for the JAMA Oncology article.
Disclosure: The study was supported by the National Cancer Institute, ASCO Conquer Cancer Foundation, and others. For full disclosures of all study authors, visit jamanetwork.com.
