Diversity within pancreatic cancer clinical trials has not improved over the past 15 years, according to a new study published in Gastroenterology.
Researchers from the Virginia Commonwealth University (VCU) Massey Cancer Center and the University of Florida sought to evaluate trends in enrollment of Black, Hispanic, Indigenous, and Asian American patients in clinical trials for pancreatic cancer treatments.
Pancreatic cancer disproportionately impacts patients who are racial or ethnic minorities, the authors note. Twelve percent of pancreatic cancer cases occur among Black patients, 9% of cases are among Hispanic patients.
15-Year Analysis of Pancreatic Cancer Clinical Trial Populations
For this study, the investigators analyzed the clinicaltrials.gov database for pancreatic cancer clinical trials conducted in the U.S. from 2005 through 2020. The team focused on trials that reported patient racial and ethnic demographics. In total, 207 trials were included, comprising 8,429 patients.
Improvement in Reporting of Patient Race
The researchers found a steady increase in trials reporting participant race and ethnicity. A significant increase in reporting occurred after the practice became federally mandated in 2017. All of the clinical trials for pancreatic cancer from 2020 that were included in this study reported participant demographics.
Despite this increase in reporting, however, the actual rate of inclusion of racial and ethnic minorities did not improve over the study period.
“We’re just now making it a requirement to report, but there’s no true requirement as far as who needs to be included in clinical trials,” said lead author Kelly Herremans, MD, surgical resident at the University of Florida College of Medicine, via a press release. “I find that shocking.”
Low Enrollment Rates for Minorities
Overall, only 8% of total participants were Black and 6% of participants were Hispanic. Asian patients accounted for 2% of trial enrollment, despite making up 3% of pancreatic cancer cases. Indigenous American patients made up 0.3% of trial enrollment, compared 0.4% of pancreatic cancer diagnoses.
“If we don’t have good diversity in clinical trials, how will we ever know whether we have certain drugs that work better in some populations than others?” said study senior author Jose Trevino, MD, surgeon-in-chief at Massey Cancer Center. “We could be throwing away a really good treatment option for racial and ethnic minority patients.”
Why Do Disparities Exist in Pancreatic Cancer Trials?
According to the researchers, the lack of diversity in pancreatic cancer clinical trials may be due to several factors, including:
- mistrust of medical establishment
- implicit bias among clinicians
- strict clinical trial inclusion criteria
- lack of diversity among recruiting clinicians
In their paper, the authors provide recommendations for addressing these barriers. For example, chronic comorbidities such as hypertension, diabetes, and human immunodeficiency virus (HIV) may automatically exclude patients from certain clinical trials. However, the authors challenge this notion as these conditions are common among some ethnic and racial minority communities and this exclusion may be contributing to reduced diversity among study populations.
“There are a ton of obstacles to get these patients into clinical trials,” said Dr. Trevino. “But this is how we’re going to understand the disease better. And it’s critically important for the future of cancer health disparities.”