Use of real-world data to understand barriers to interventional clinical trial enrollment in community oncology clinics (COC).

Abstract

2061 Background: Increasing enrollment in clinical trials remains a national priority, yet there are limited data from COCs on the degree to which common trial exclusion criteria (EC) and socioeconomic factors play a role in low enrollment rates. Methods: We analyzed data from the nationwide Flatiron Health electronic health record (EHR) derived de-identified database. COC were eligible if they had given a clinical trial study drug to ≥2 patients (pts)/year. We included pts with one of eight advanced or metastatic solid tumors who received ≥1 line of systemic anticancer therapy between 1/1/2014 and 11/30/2019. We defined EC as either: creatinine > 1.5 mg/dl or Ccl < 45 ml/min, Hb < 9 g/dL, ANC < 1500/ul, plts < 100,000/ul, bilirubin > 1.5 upper limit of normal (uln) or AST/ALT > 2.5 uln within 30 days or ECOG performance status (PS) ≥ 2 within 60 days prior to start of therapy. We calculated the percentage of pts with ≥1 EC relative to the group of candidate pts, stratified by therapy line (1L, 2L, 3L+). We used multivariate logistic regression models to evaluate the effect of EC and socioeconomic factors (age, race, Medicaid) on the likelihood of receiving a clinical study drug for each line of therapy. Results: In this sample of 35 COCs, 26,988 pts received ≥1 systemic therapy. Pts with ≥ 1 EC: 28.4% in 1L, 34.2% in 2L, 37.4% in 3L. Percentages of pts with an ECOG PS ≥ 2 were: 15.6% (1L), 18.2% (2L), 19.8% (3L). Pts receiving a clinical study drug: 1.7% of 26,988 in 1L, 2.0% of 12,738 in 2L, 2.9% of 5,333 in 3L+, and 3.1% in any line. Excluding pts with ≥1 EC from the denominator modestly improved overall accrual: 2.0% of 19,729 in 1L, 2.3% of 8,588 in 2L, 3.7% of 3,470 in 3L+. In multivariate logistic regression, ECOG PS ≥ 2 was strongly associated with not receiving a study drug [odds ratio (95% CI); 1L: 0.25 (0.16-0.4); 2L: 0.28 (0.17-0.49); 3L: 0.21 (0.1-0.44)]. The likelihood of receiving a clinical study drug (any line) was lower for pts who are Black [0.63 (0.48-0.82)], Latino [0.49 (0.32-0.75)], and pts older than 70 years [0.63 (0.54-0.72)]. Medicaid pts were not significantly less likely to receive study drug [0.83 (0.64-1.07)]. Conclusions: In COC, common trial EC reduce pt availability for trials by > 25%. Poor PS is highly prevalent and influential. These EC and complex trial requirements challenge COC’s ability to recruit representative pt populations. Future efforts to increase enrollment in trials must consider common EC along with well known barriers to enrollment of unrepresented groups.