Older Adult Participation in Cancer Clinical Trials: Barriers & Future Implications
According to the FDA, most of what researchers know about the risks and benefits of cancer therapeutics derives from clinical trials conducted in younger, healthier patients (Singh, Beaver, Kim, & Pazdur, 2017), leading to systemic differences in treatment and disparities in health outcomes between older and younger patients with cancer. Additionally, with diagnostic and management strategies extrapolated from data on younger patients, delivering informed cancer care among the more aging population is quite challenging (Habr, McRoy, & Papadimitrakopoulou, 2021). Since age is the most significant risk factor for cancer (Lackman, Vickers, & Hsu, 2020), older cancer patients remain vastly underrepresented in clinical research. Thus, it is critical to identify potential barriers impacting cancer treatment studies among this population.
A more detailed evaluation of older adult patients is needed to capture factors other than chronologic age that predict morbidity and mortality, such as a comprehensive geriatric assessment (Hurria, 2007). A SWOG study from 2012 (S0316) found that the primary reasons for the non-accrual of older adults were trial unavailability, patient ineligibility, and strict exclusion criteria such as functional status and organ function comorbidities (Javid, et al., 2012). Additionally, treatment toxicity is the most cited reason by physicians for not enrolling older adults in clinical trials (Sedrak, et al., 2021). Therefore, suggested interventions include the availability of clinical research staff to explain the protocols and to have supportive care measures evaluated to improve treatment tolerance.
Further, given the substantial cancer burden among the elderly, policies and initiatives surrounding the current research infrastructure may need to be modified to accommodate the needs of older patients by meeting the patients where they are rather than where they should be to fit the current structure. With that suggestion, broadening the clinical study design to be less restrictive concerning excluding patients based on comorbidity and functional status may help improve enrollment of older adults to studies (Lackman, Vickers, & Hsu, 2020).
