Older adults (OA) in clinical trials: Where are they? Representation of OA in clinical trials conducted at the national cancer institute (NCI) clinical center.

Abstract

e18517 Background: Clinical trials are a significant source of evidence for diagnostic and management strategies in cancer patients. Diversity, equity, and inclusion are necessary to provide access to clinical trials and improve care. Despite the increase of OA in the United States (US), OA are still under-represented in clinical trials, with a lack of information on clinical outcomes and safety. The NCI provides oncologic care on research studies conducted at the Clinical Center (CC), the research hospital of the National Institutes of Health (NIH) where third-party payers are neither notified nor invoiced for treatments received. Participants come from all over the US and are primarily referred by their primary oncologists. We sought to evaluate the participation of OA in clinical trials at the NCI-CC. Methods: In this retrospective analysis, OA were defined as participants aged ≥65 years. The demographic data of OA enrolled from 2005 to 2019 were retrieved from the Biomedical Translational Research Information System (BTRIS), the NIH clinical research data repository. Data on the incidence of new cancer diagnoses in the US population for the same period (2005-2019) were obtained from the Surveillance, Epidemiology, and End Results (SEER) program. We compared the proportions of OA enrolled in NCI-CC clinical trials with the corresponding data from SEER program. We further stratified the OA into four age subcategories: from 65 to 69, from 70 to 74, from 75 to 79, and older than 80 years of age. No inferential statistical analyses were performed. Results: A total of 37,326 participants were enrolled from 2005 to 2019 on NCI-CC clinical trials. The number of OA = 7,934 (21.3%). According to the SEER program, 11,017,070 people were diagnosed with cancer from 2005 to 2019, and 5,971,607 (54.2%) were OA. Notably, the proportions of OA enrolled in NCI-CC was lower than the SEER data in all the subcategories. Patients ≥75 years accounted for the most under-represented (Table). Conclusions: OA are under-represented in clinical trials conducted at the NCI-CC from 2005 to 2019, emphasizing the need to “geriatricize” clinical trials. Adaptations of trial design such as expansion of eligibility criteria, utilization of geriatric assessment tools, and inclusion of OA-specific enrollment targets may reduce barriers to enrollment. Outreach initiatives to the oncology community to reinforce the need for increased referral of OA along with incorporation of telehealth for trial screening and assessments could also be considered to expand enrollment and increase the evidence base to guide treatment of OA with cancer. [Table: see text]