Eligibility Criteria Perpetuate Disparities in Enrollment and Participation of Black Patients in Pancreatic Cancer Clinical Trials

Abstract

PURPOSE Clinical trials determine safety and efficacy of cancer therapeutics and establish standards of care. Minority patient participation in cancer clinical trials is dismal. We aimed to determine the impact of eligibility criteria on disparities in pancreatic ductal adenocarcinoma (PDAC) clinical trial candidacy. METHODS Traditional PDAC trial eligibility criteria were obtained from ClinicalTrials.gov. Patients with PDAC who sought care at Virginia Commonwealth University Health from 2010 to 2019 were included. Clinical data were obtained from billing codes and discrete values in the electronic medical record. Eligibility criteria differences between racial groups were determined using chi-squared tests and unconditional maximum likelihood-based odds ratios. RESULTS Among 676 patients, most identified as Black or White race (42.5% and 51.6%, respectively). Using traditional criteria, Black patients were more likely to be ineligible for participation compared with White patients (42.4% v 33.2%, P = .023) secondary to hypoalbuminemia (14.1% v 7.9%, P = .023), HIV (3.1% v 0.3%, P = .010), hepatitis B (1.7% v 0%, P = .043), and hepatitis C (9.1% v 3.4%, P = .005). Black patients were also numerically more likely to be ineligible because of renal dysfunction, recent coronary stenting, and uncontrolled diabetes mellitus. Prior cancer treatment excluded fewer Black than White patients (9.1% v 14.0%, P = .072), most attributable to lower rates of neoadjuvant chemotherapy received. Strategic eligibility criteria revisions could equalize ineligibility rates between Black and White patients (26.8% v 24.8%, P = .581). CONCLUSION Traditional eligibility criteria differentially exclude Black patients from participating in PDAC clinical trials. These criteria perpetuate disparities, limit generalizability, and are often not medically justifiable. Revised criteria may improve participant diversity, without compromising safety or study results.

Clinical Trial Eligibility Criteria: A Structural Barrier to Diversity in Clinical Trial Enrollment

“…AFFILIATION 1 Brody School of Medicine at East Carolina University, Greenville, NC CORRESPONDING AUTHOR Rebecca A. Snyder, MD, MPH, Surgery and Public Health, Brody School of Medicine at East Carolina University, 600 Moye Blvd Suite 4S-24, Greenville, NC 27834; Twitter: @RSnyder_MD; e-mail: snyderre19@ecu.edu.…”

“…Perhaps the most important finding reported by Riner et al 1 is that when traditional clinical trial eligibility criteria are revised, there is no longer any difference in eligibility among Black and White patients. Despite a plethora of studies identifying and describing racial disparities in cancer treatment and outcomes, few offer specific, tangible solutions like those proposed here.…”

“…In the article that accompanies this editorial, Riner et al 1 apply pancreatic cancer clinical trial eligibility criteria to a real-world cohort of patients, finding that Black patients are less likely to be eligible to participate compared with White patients. These findings suggest that restrictive eligibility criteria are a structural barrier that disproportionately affects minority populations, which, if addressed, could improve diversity of clinical trial enrollment.…”

“…7 As the authors point out, poorly controlled diabetes can be a manifestation of limited access to primary and subspecialty endocrinology care, nutritional counseling, and access to healthy foods. Each of the identified comorbidities by Riner et al 1 reflect the historical disadvantage experienced by minorities in the United States, which then amplifies downstream disparities in cancer treatment, including clinical trial representation. Not surprisingly, the only criteria for which White patients were excluded at higher rates was receipt of prior therapy, a likely surrogate for better health care access and more favorable social determinants of health.…”

“…As Riner et al 1 propose in their study, underlying structural barriers, specifically overly restrictive clinical trial eligibility criteria, may inadvertently disqualify the very patients that we most need to enroll. In an analysis of 20 SWOG clinical trials, the mean number of study eligibility criteria was 16.1, of which 60% (9.8) were directly related to comorbidities or performance status.…”