Eligibility criteria add to race gap in pancreatic cancer clinical trials

Traditional eligibility criteria differentially exclude Black patients from participating in clinical trials for pancreatic ductal adenocarcinoma (PDAC), according to a study published online March 22 in the Journal of Clinical Oncology.

Andrea N. Riner, M.D., M.P.H., from University of Florida in Gainesville, and colleagues assessed the impact of eligibility criteria on disparities in PDAC clinical trial candidacy. The analysis included 676 patients with PDAC who sought care at Virginia Commonwealth University Health (2010 to 2019).

The researchers found that using traditional criteria, Black patients were more likely to be ineligible for participation versus White patients (42.4 versus 33.2 percent) due to hypoalbuminemia (14.1 versus 7.9 percent), HIV (3.1 versus 0.3 percent), hepatitis B (1.7 versus 0 percent), and hepatitis C (9.1 versus 3.4 percent). Furthermore, Black patients were also more likely to be ineligible because of renal dysfunction, recent coronary stenting, and uncontrolled diabetes mellitus. White patients were excluded more often due to prior cancer treatment (14.0 versus 9.1 percent).

"Strategic eligibility criteria revisions could equalize ineligibility rates between Black and White patients," the authors write. "Revised criteria may improve participant diversity, without compromising safety or study results."

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