Abstract PR-09: Eligibility criteria perpetuate disparities in enrollment and participation in pancreatic cancer clinical trials
Authors: Riner Andrea N. , Girma Selamawit , Skoro Nevena , Gal Tamas S. , Herremans Kelly M. , Mukhopadhyay Nitai , Vudatha Vignesh , Raman Shreya , George Thomas , Trevino Jose G. 
Published: January 2022

Introduction: Clinical trials determine efficacy and safety of cancer therapeutics and set the standard of care. Inequitable representation of participants leaves gaps in our knowledge, limits opportunities to investigational therapeutics and subsequently perpetuates disparities in survivorship. Clinical trial eligibility criteria have been postulated to differentially impact certain racial/ethnic groups which have higher prevalence of infectious and chronic diseases. We aimed to determine the impact of eligibility criteria on disparities in pancreatic cancer clinical trial candidacy. Methods: Common eligibility criteria for Phase 2 and 3 pancreatic cancer trials listed in clinicaltrials.gov were compiled for simulation of a clinical trial screening process. Patients with pancreatic ductal adenocarcinoma who sought care at VCU Massey Cancer Center (Richmond, VA) from 2010-2019 were included. Clinical variables pertaining to eligibility criteria were obtained from billing codes and discrete values in the medical record. Inclusion/exclusion criteria were applied to determine overall eligibility and for individual criterion. Chi-squared tests were utilized to identify statistically significant differences in patient eligibility between racial groups. Results: A total of 676 patients with pancreatic cancer were identified, with Black (42%) and White (52%) patients comprising the majority of the patient population. Black patients were significantly more likely than White patients to be deemed ineligible based on Creatinine (6.08% vs 2.27%, p = 0.036), HIV (3.136% vs 0.286%, p = 0.01), Hepatitis B (1.742% vs 0%, p = 0.043), and Hepatitis C (9.06 vs 3.43%, p = 0.005). Black patients were also more likely to be ineligible based on Albumin (12.45% vs 7.47%, p = 0.076), history of coronary stenting in the past 6 months (1.39% vs 0%, p = 0.087), and uncontrolled diabetes (8.96% vs 6.07%, p = 0.244), although differences in these criteria did not achieve statistical significance at 5% level. History of prior cancer treatment was the only variable that excluded less Black patients than White patients (9.06% vs 14.0%, p = 0.072) and was attributable to more White patients initiating neoadjuvant chemotherapy for their pancreatic cancer prior to seeking care at VCU. After applying all criteria, Black patients were more likely to be ineligible for participation compared to White patients (42.0% vs 33.3%, p = 0.039). Conclusion: Standard pancreatic cancer clinical trial eligibility criteria differentially exclude Black patients from participating in clinical trials. These criteria perpetuate racial disparities, limit generalizability to real world clinical scenarios, and are often not medically justifiable. Alternative eligibility criteria can improve representation of diverse participants, provide more equitable access to investigational therapeutics and reduce disparities in survivorship, without compromising patient safety or study results.

Citation Format: Andrea N. Riner, Selamawit Girma, Nevena Skoro, Tamas S. Gal, Kelly M. Herremans, Nitai Mukhopadhyay, Vignesh Vudatha, Shreya Raman, Thomas George, Jose G. Trevino. Eligibility criteria perpetuate disparities in enrollment and participation in pancreatic cancer clinical trials [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PR-09.