Black patients are significantly more likely than White patients to be excluded from clinical trials for a wide range of eligibility criteria, according to researchers who used a simulated pancreatic cancer clinical trial screening process.
Andrea N. Riner, MD, MPH, a research fellow and general surgery resident at the University of Florida in Gainesville, presented the findings at the American Association for Cancer Research Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved (Abstract PR-10).
She told a press briefing that prior research has consistently demonstrated that racial and ethnic minorities are significantly underrepresented in clinical trials, and that clinical trials not including diverse populations may present an incomplete or inaccurate picture of how patients will respond to various medications.
"Inequitable representation of participants leaves gaps in our knowledge, limits opportunities to receive investigational therapeutics, and subsequently perpetuates disparities in survivorship."
Research Findings
Under the mentorship of Jose G. Trevino, MD, Surgeon in Chief of VCU Massey Cancer Center, Riner and her teammates examined criteria that are typically used to determine whether patients are qualified to participate in a clinical trial. They found that many trials use criteria that have been in place for a long time. Depending on several factors, she noted that "these criteria may not be medically justifiable."
The researchers simulated a screening process for a pancreatic cancer clinical trial, using data from patients with pancreatic ductal adenocarcinoma who sought care at VCU Massey Cancer Center in Richmond, Va., from 2010 to 2019. They then compiled common eligibility criteria for Phase II and Phase III pancreatic cancer trials listed in http://clinicaltrials.gov, and modeled inclusion and exclusion based on clinical variables determined from billing codes and medical records.
The criteria that had the highest propensity for exclusion of Black patients were related to nutrition and infectious diseases. These included the following:
* albumin (14.07% of Black patients were excluded, compared with 7.91% of White patients);
* HIV (3.136% of Black patients were excluded, compared with 0.286% of White patients);
* hepatitis B (1.742% of Black patients were excluded, compared with 0% of White patients); and
* hepatitis C (9.06% of Black patients were excluded, compared with 3.43% of White patients).
Several other criteria also disproportionately excluded Black patients, although the results did not reach statistical significance. The only criteria that excluded more White patients than Black patients was a history of prior cancer treatment, Riner said.
Fourteen percent of White patients were excluded based on prior cancer treatment, compared with 9.06 percent of Black patients. This difference reflects more White patients receiving neoadjuvant therapy for their current pancreatic cancer, she explained.
When criteria were removed that the researchers felt were not crucial to patient safety or well-being, the difference in eligibility was minimized.
"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," Riner said. "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."
She noted the findings could be used to modify existing clinical trial enrollment to be more racially and ethnically inclusive.
"Modifications should be made on a trial-by-trial basis given the range of therapeutics being investigated," she said, noting that chemotherapy trials may require different criteria than immunotherapy trials based upon how the drugs work. "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.
"Alternative eligibility criteria can improve the diversity of participants, provide more equitable access to investigational therapeutics, and reduce disparities in survivorship without compromising patient safety or study results," Riner added.
One limitation of the study is that it was based on data from a single cancer center, so the results may not be generalizable to the broader public. Also, based on the demographics of the patients in the study, researchers were only able to compare eligibility Black patients being eligible for pancreatic cancer clinical trials than White patients.
Riner noted that the team suspects their findings may be applicable to other minority groups, but further research would be necessary to confirm the results.
"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," she said.
"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 and provide more equitable access to investigational therapy."
Kurt Samson is a contributing writer.