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.

FIG 1.

Clinical trial ineligibility for select traditional criteria, by racial group. The percentage of patients deemed ineligible for clinical trial participation on the basis of individual criterion are shown by race. Albumin, HIV, hepatitis B, and hepatitis C contributed significantly to higher rates of ineligibility for Black patients compared with White patients (*P < .05).

FIG 2.

Overall clinical trial ineligibility for traditional and revised criteria, by racial group. Traditional criteria led to a significantly higher percentage of Black patients being ineligible, but revised criteria eliminated this disparity (*P = .023).

FIG A1.

Pancreatic cancer clinical trials Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagram. Trials registered in ClinicalTrials.gov were reviewed to identify commonly used eligibility criteria to screen patients for possible enrollment.