Although lack of clinical trial participation is associated with worse survival outcomes in some malignancies, data show that Black patients with cancer represent just 7.3% of participants—and only 4.5% for such cancers as multiple myeloma—in cancer clinical trials, compared with 84.2% for White patients. Studies also show that enrollment of Black patients in cancer clinical trials is hindered by clinical trial design, which includes strict inclusion or exclusion criteria.
The results from a study by Riner et al investigating the impact on eligibility criteria on disparities in pancreatic cancer clinical trial participation showed that standard criteria, such as those related to nutrition and infectious diseases (including serum albumin levels and HIV and hepatitis B and C status) may disproportionately exclude Black patients.
Standard criteria perpetuate racial disparities, limit generalizability to real-world clinical scenarios, and are often not medically justifiable, concluded the study authors. The study was presented at the virtual 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved.
Study Methodology
The researchers simulated a screening process for a pancreatic cancer clinical trial using data from 676 patients—42% Black and 52% White—with pancreatic ductal adenocarcinoma who sought care at VCU Massey Cancer Center between 2010 and 2019. They compiled common eligibility criteria for phase II and phase III pancreatic cancer trials listed in ClinicalTrials.gov, and modeled inclusion and exclusion based on clinical variables determined from billing codes and medical records. Chi-squared tests were utilized to identify statistically significant differences in patient eligibility between racial groups.
KEY POINTS
- The criteria that had the highest propensity for clinical trial exclusion between Black and White patients with pancreatic cancer included serum albumin levels, HIV status, hepatitis B status, and hepatitis C status.
- Black patients were also more likely to be ineligible based on albumin, a history of coronary stenting in the past 6 months, and uncontrolled diabetes, although differences in these criteria did not achieve statistical significance at 5% level.
- After applying all criteria, Black patients were more likely to be ineligible for participation compared to White patients (42.0% vs 33.3%).
Results
The researchers found that Black patients were significantly more likely than White patients to be deemed ineligible based on creatinine levels (6.08% vs 2.27%, P = .036), HIV status (3.136% vs 0.286%, P = .01), hepatitis B status (1.742% vs 0%, P = .043), and hepatitis C status (9.06 vs 3.43%, P = .005). Black patients were also more likely to be ineligible based on albumin (12.45% vs 7.47%, P = .076), a history of coronary stenting in the past 6 months (1.39% vs 0%, P = .087), and uncontrolled diabetes (8.96% vs 6.07%, P = .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 fewer Black patients than White patients (9.06% vs 14.0%, P = .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 = .039).
“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,” concluded the study authors.
“The results of our study confirmed our suspicion that standard criteria lead to significantly fewer Black patients being eligible for pancreatic cancer clinical trials than White patients,” said Andrea N. Riner, MD, MPH, a research fellow and general surgery resident at the University of Florida in Gainesville, and lead author of the study, in a statement. “We are creating bias in who may even qualify to participate, and we are sometimes doing so without a truly valid medical reason to exclude someone. Modifications should be made on a trial-by-trial basis given the range of therapeutics being investigated. These decisions could be made between the sponsor of the trial and an advisory board of medical experts that would be able to decide which criteria are absolutely necessary.”
Disclosure: Members of the research team received salary and research support from the National Human Genome Research Institute, the National Cancer Institute, the VCU Massey Cancer Center Informatics Core, and the Joseph and Ann Matella Fund for Pancreatic Cancer Research.
