Social determinants of health and medical comorbidities led to clinical trial ineligibility in 72% of patients with solid tumors, with no significant differences by race.
Observational (n=151)
No
A substantial proportion of patients with solid tumors at a safety-net hospital face medical and social barriers to clinical trial participation, with no significant differences across racial groups.
e17152 Background: In 2025, the FDA approved 14 therapies across multiple malignancies, reflecting advances in tumor genomics, targeted agents, and immuno-oncology that have reshaped outcomes. Despite these gains, clinical trials underrepresent populations burdened by cancer, raising equity concerns. We evaluated the impact of social determinants of health (SDOH) and medical comorbidities on clinical trial non-enrollment at a safety-net hospital. We hypothesize that SDOH contribute substantially to trial ineligibility. Methods: We conducted a retrospective study of patients with solid tumors in Memphis, TN from 2020–2025. Cases were identified via EMR query. Demographic, clinical, and social variables were collected using prespecified definitions. Based on common criteria for ineligibility, medical ineligibility (MI) was defined as ECOG ≥2, major organ dysfunction or uncontrolled infection. Social ineligibility (SI) included missed appointments > 30%, tobacco/alcohol/substance use, or psychiatric illness impairing adherence. Descriptive statistics summarized cohort characteristics, and χ² tests compared eligibility patterns by race and by medical vs social criteria. Results: In this cohort of N = 151 patients, the median age was 67 years; 64% were male; 71% were African American (AA) and 22% were Caucasian. Cancer types included: prostate (N = 33), other genitourinary cancers (N = 24), colorectal (N = 23), gastric/esophageal (N = 6), other GI cancers (N = 14), lung (N = 19), breast (N = 17), other (N = 15). Overall, 72% were ineligible. MI accounted for 21%, SI for 25%, and both for 26%. Top medical comorbidities were uncontrolled pain (15%), ECOG ≥2 (13%) and concomitant cancers (11%, Table 1). Top social barriers were tobacco use (31%), alcohol use (30%) and non-compliance (13%). There was no significant difference by race in MI (60.6% vs 50.0%, p = 0.28). Similarly, there was no significant difference between Caucasians and AAs in SI (51.5% vs 43.9%, p = 0.40). When comparing eligibility, MI (53%) and SI (49%) were similar, with no significant difference (p = 0.51). Conclusions: A substantial proportion (73%) of patients at our safety-net hospital face medical and/or social barriers to clinical trial eligibility, irrespective of race. χ² analyses demonstrated no racial differences in either MI or SI, indicating that barriers were similar across racial groups. These findings informed development of an ongoing prospective study examining how SDOH and patient perspectives contribute to underrepresentation in clinical trials. Breakdown of trial ineligibility and top medical and social barriers (N=151). Eligibility Medical barriers Social barriers Eligible (28%) Uncontrolled pain (15%) Tobacco use (31%) Ineligible (medical barriers, 21%) ECOG > or = 2 (13%) Alcohol use (30%) Ineligible (social barriers, 25%) Concomitant cancer (11%) Non-compliance (13%) Ineligible (both barriers, 26%)
Aksionav et al. (Thu,) conducted a observational in Solid tumors (n=151). Social determinants of health and medical comorbidities was evaluated on Clinical trial ineligibility. Social determinants of health and medical comorbidities led to clinical trial ineligibility in 72% of patients with solid tumors, with no significant differences by race.
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