Exclusion of people from oncology clinical trials based on functional status and other criteria.

Abstract

e23002 Background: To improve equity in cancer care, oncology clinical trials should include populations experiencing health care disparities, including people with disabilities – 28.7% of U.S. adults in 2022. Recent attention has focused on discriminatory exclusion of people with disabilities from clinical trials, counter to federal legislation and research guidelines. The purpose of this study was to examine exclusion of people with disabilities from clinical trials based on performance status (PS) and discretionary decisions by investigators. Methods: We reviewed eligibility criteria in approved interventional Phase III and IV oncology clinical trials listed on ClinicalTrails.gov between 01/01/2019 - 12/31/2023. Eligibility criteria often included functional status thresholds assessed using the Eastern Cooperative Oncology Group (ECOG) Performance Status scale or Karnofsky Performance Scale (KPS). We used qualitative methods to review criteria relating to functional impairments and investigators’ discretionary exclusions. Results: Among 96 oncology clinical trials, approximately 40% had restrictive ECOG and KPS scale thresholds, explicitly including only patients with ECOG 0 or 1, or equivalent KPS 70 or greater. Only 20% of studies included patients with ECOG 2 and KPS 60. 82 (85.4%) allowed broad investigator discretion to determine eligibility. Content analysis of discretionary criteria revealed concerns about safety, compliance, and informed consent. Multiple studies contained miscellaneous exclusion criteria that could potentially exclude people with disability (e.g., inability to tolerate imaging, needle-phobia). No studies described making reasonable accommodations for participation. Conclusions: 2024 Food and Drug Administration guidelines and the 2021 recommendation by the American Society of Clinical Oncology (ASCO) - Friends of Cancer Research collaborative recommend including patients with ECOG 2 and KPS 60 in oncology trials. We found that oncology trials often exclude people with more restrictive PS scores than the FDA guidelines, as well as other criteria that relate to disability. Furthermore, oncology trials allow investigators broad discretion in determining eligibility. These criteria may particularly target persons with psychiatric or cognitive disabilities. Further research should examine whether rationales for excluding these populations are appropriate. To ensure that participants represent the populations that will receive interventions, clinical trials should make efforts to provide reasonable accommodations for trial participation.