Black Americans are far less likely to be included in clinical trials of pancreatic cancer drugs than white Americans, and eligibility criteria are a significant factor in that gap, according to a new study.
"The standard of care in cancer treatment is informed by studies conducted with predominantly non-Hispanic white patients," said study author Dr. Jose Trevino, chairman of surgical oncology at Virginia Commonwealth University School of Medicine.
"Revising the standard criteria for clinical trial enrollment could have a profound effect on increasing eligibility of underserved populations, reducing disparities in trial participation and creating results that are more reflective of the patients that we serve," he said in a university news release.
Clinical trials determine a drug's safety and effectiveness. Because they lead to nearly all standards of care in the United States, a lack of Black participants can affect their treatment, the researchers noted.
Their analysis of data on pancreatic cancer patients treated in the United States between 2010 and 2019 found that 42% of Black patients were ineligible for trials compared to 33% of white patients.
That's because traditional eligibility criteria disproportionately prevent Black patients from participating, according to the study, published recently in the Journal of Clinical Oncology.
More than 62,000 people in the United States will be diagnosed with pancreatic cancer this year, according to the American Cancer Society.
Black, Asian, Pacific Islander, American Indian, Alaskan Native and Hispanic patients have long been underrepresented in pancreatic cancer trials, and eligibility criteria haven't gotten sufficient attention, the researchers said.
Other factors linked to under-representation of minorities in clinical trials include distrust of the health care system, racism, lack of diversity among health care providers, and barriers to health care access.
Although clinical trial criteria are meant to reduce risk and create a similar patient population, they often inadvertently prevent large groups from receiving experimental therapies, the authors said.
In many cases, patients are excluded because they have manageable health conditions such as HIV, hepatitis, chronic kidney disease, diabetes, obesity and malnutrition.
"These criteria are often not medically justifiable," said lead author Dr. Andrea Riner, a surgical resident at the University of Florida College of Medicine. "Given the deadliness of pancreatic cancer, newer, FDA-approved treatments are often administered for cancer patients with these medical conditions despite the absence of such patients in clinical trials."
Researchers propose that many of these conditions be removed from eligibility criteria for pancreatic cancer trials, she added.
Enlisting specialists who can help manage other health problems during a cancer clinical trial could enable more patients to be enrolled, the authors said.
To learn more about clinical trials, go to the U.S. National Institutes of Health.
SOURCE: Virginia Commonwealth University, news release, March 29, 2022