Clinical Trial Participation Among Older Adult Medicare Fee-for-Service Beneficiaries With Cancer

Abstract

ImportanceClinical trials play a critical role in the development of novel cancer therapies, and precise estimates of the frequency with which older adult patients with cancer participate in clinical trials are lacking.ObjectiveTo estimate the proportion of older adult Medicare Fee-for-Service (FFS) beneficiaries with cancer who participate in interventional cancer clinical trials, using a novel population-based methodology.Design, Setting, and ParticipantsIn this retrospective cohort study evaluating clinical trial participation among older adult patients with cancer from January 1, 2014, through June 30, 2020, claims data from Medicare FFS were linked with the ClinicalTrials.gov to determine trial participation through the unique National Clinical Trial (NCT) identifier. The proportion 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 was estimated. Data analysis was performed from November 18, 2020, to November 1, 2021.ExposuresPatients with cancer aged 65 years or older with Medicare FFS insurance, with and without active cancer treatment.Main Outcomes and MeasuresEnrollment in clinical trials among all patients with cancer 65 years and older and among patients receiving active cancer treatments as defined by the presence of at least 1 NCT identifier corresponding to an interventional cancer clinical trial in Medicare claims.ResultsAmong 1 150 978 patients (mean [SD] age, 75.7 [8.4] years; 49.9% men and 50.1% women) with newly diagnosed or newly recurrent cancer in 2015, 12 028 (1.0%) patients had a billing claim with an NCT identifier indicating enrollment in an interventional cancer clinical trial between January 2014 and June 2020. In a subset of 429 343 patients with active cancer treatment, 8360 (1.9%) were enrolled in 1 or more interventional trials. Patients enrolled in a trial tended to be younger, male, a race other than Black, and residing in zip codes with high median incomes.Conclusions and RelevanceFindings 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.

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“…Underrepresentation of diverse racial and ethnic populations in clinical trials is also concerning. In a recent study on Medicare beneficiaries with cancer, only 1% to 1.9% of participants had medical claims for interventional clinical trials, and most participants were younger and a race other than Black …”

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“…Therefore, the broader clinical implications of the data may be limited, as trial participants are often not a fair representation of the real-world patient population. Clinical trial participants tend to be younger, fitter, a race other than Black, and residing in zip codes with high median incomes . Consequently, the effect of ARSI therapy on an older, socioeconomically underserved patient population might be even greater than presented by Nowakowska et al…”

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“…Inadequate and skewed enrollment into clinical trials has been recognized for more than 30 years, generating calls for action and policy remedies. In a retrospective cohort study of more than 1 million Medicare beneficiaries in this issue of JAMA Oncology , Green et al report that the crisis in cancer research enrollment continues: fewer than 1 out of every 50 older adults who are undergoing active cancer therapy were enrolled in a clinical trial. They also found substantial disparities by race, age, socioeconomic status, and comorbidity.…”

“…The study by Green et al also found that fewer than 2% of older adult patients undergoing cancer-directed therapy were enrolled in therapeutic trials. This is a distressingly low number, but not a surprising one.…”

“…Given the mission-critical need to track and improve research participation, future work should refine our ability to accurately track trial enrollment at the institutional and national level. The efforts of Green et al are a good step in this direction. A national report on clinical trial enrollment would go a long way toward ensuring transparency, improving accountability, and identifying opportunities for improving our ongoing crisis of skewed and inadequate trial enrollment.…”