Despite the fact that certain racial and ethnic minorities get pancreatic cancer more often, are diagnosed at a younger age, and die sooner, clinical trials fail to include representative proportions of non-White patients at every phase of study, according to research that was selected for presentation at Digestive Disease Week® (DDW) 2021.
“We see disparities in representation across all kinds of clinical trials, so we were not surprised to see that it also occurs in pancreatic cancer trials. But hopefully we can make a change in that arena in the future,” said Kelly Herremans, MD, lead researcher on the study and surgical research fellow at the University of Florida College of Medicine, Gainesville.
Researchers analyzed data from 8,429 participants in 207 clinical trials in the U.S. for treatments for pancreatic ductal adenocarcinoma on ClinicalTrials.gov, a national registry of clinical trial data. Gender was reported in 99% of the trials, while race and ethnicity were reported in 49.3% and 34.7% of trials, respectively.
Minorities were substantially underrepresented in trials:
- Black patients represented 8.2% of trial participants vs. 12.4% of the U.S. incident cases.
- Hispanic patients represented 6% of trial participants compared to 8.5% of the U.S. incident cases.
- Asian or Pacific Islander patients represented 2.4% of trial participants vs. 3.3% of the U.S. incident cases.
- American Indians and Alaska Native patients represented 0.3% of trial participants compared to 0.4% of the U.S. incident cases.
White patients were overrepresented, making up 84.7% of the total trial participants, while they account for 82.3% of the total U.S. incident cases. In all, 54.8% of trial participants were male and 45.2% female.
Diversity is important for clinical trials because previous research has shown racial differences in tumor biology, Herremans said. For example, Black patients have different rates of both somatic and germline mutations when compared to other racial subgroups, which means they may respond differently to treatment.
“We are treating everybody as if they were the same and their tumors would react the same to treatments, but it’s important to look at the ancestral differences of tumor biology and therapeutic response,” Herremans said.
Edited by Gary Cramer