Clinical trials are responsible for determining the safety and efficacy of drugs, and lead to virtually all standards of cancer care in the U.S. However, a recent study conducted by researchers from VCU Massey Cancer Center, the University of Florida College of Medicine and UF Health Cancer Center found that minority patient participation in cancer clinical trials is alarmingly low. This significant disparity creates a substantial gap between the patient populations in which the drugs are tested and those that are treated after drugs are federally approved. One reason for this gap is standard clinical trial criteria that disproportionately excludes Black patients.
In recent findings published in the Journal of Clinical Oncology, the researchers determined that traditional eligibility criteria — a set of standardized requirements that must be met for a patient to enroll in a clinical trial — disproportionately prevents Black patients from participating in pancreatic cancer clinical trials. Looking at pancreatic cancer patients treated between 2010 and 2019, the researchers found that 42% of Black patients were ineligible for clinical trials compared to 33% of white patients.
“The standard of care in cancer treatment is informed by studies conducted with predominantly non-Hispanic white patients,” said study co-corresponding author Jose Trevino, M.D., FACS, surgeon-in-chief at Massey Cancer Center and chair of the Division of Surgical Oncology at the VCU 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.”
The American Cancer Society estimates that more than 62,000 people will be diagnosed with pancreatic cancer in 2022. Historically, Black, Asian or Pacific Islander, American Indian or Alaskan Native and Hispanic patients have been underrepresented in pancreatic cancer clinical trials. There are a number of known factors that contribute to the underrepresentation of minorities in clinical trials, including distrust in the health care system, systemic racism, lack of diversity among medical providers, barriers to health care access, among others. However, a factor that has been largely ignored is eligibility criteria.
Although criteria are intended to reduce risk and help define a similar patient population, they often inadvertently prevent large subsets of patients from receiving investigational therapies. Medical conditions that can often be medically controlled are associated with underserved populations can exclude many patients from being eligible for a trial, including HIV, hepatitis, chronic kidney disease, diabetes, obesity and malnutrition.
“These criteria are often not medically justifiable. 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,” said study lead author Andrea Riner, M.D., M.P.H., surgical resident at the University of Florida College of Medicine. “We propose that many of these medical conditions be removed from eligibility criteria for pancreatic cancer clinical trials.”
The study’s authors suggest that collaborating with specialists who can comanage these additional medical conditions during a cancer clinical trial could allow for more patients to be safely enrolled instead of being denied eligibility.
Because many pancreatic tumors directly trigger diabetes, the researchers propose that uncontrolled diabetes should not exclude a patient from enrolling in a pancreatic cancer clinical trial if they agree to be closely monitored by an additional specialist throughout the trial.
“Diabetes can be well controlled in a relatively short period of time for a majority of patients,” said Trevino, who also holds the Walter Lawrence, Jr., Distinguished Professorship in Oncology at Massey Cancer Center. “However, poorly controlled diabetes may reflect the impact of underlying social determinants of health and inadequate access to care, and thus, clinical trial centers may need to facilitate diabetes care with providers in local communities or via telehealth.”
Additionally, health insurance coverage can affect a patient’s ability to enroll in a clinical trial. Black patients tend to be diagnosed with pancreatic cancer at a younger age than white patients and therefore are less likely to be covered by Medicare. Not all testing and treatment within a clinical trial is wholly covered by the trial or payers, leading some patients to have higher out-of-pocket expenses and further perpetuating disparities in clinical trial participation.
The study authors argue that effectively changing the standards by which eligibility criteria are developed and evaluated cannot be accomplished by individual researchers, but rather through a collective effort by a variety of stakeholders influential to the implementation of clinical trials.
“Everyone has a part to play in changing this. Patient advocacy groups and professional societies can demand policy change; trial funders and regulatory agencies should require medical justification for each eligibility criteria prior to funding or approving a study; and industry partners or other stakeholders should be held accountable for their role in the development of a clinical trial that creates undue barriers for patients to participate,” said study co-corresponding author Thomas George, M.D., FACP, associate director for clinical research at UF Health Cancer Center and professor of medicine at the University of Florida College of Medicine.
Diverse participation is not only important for providing equal access to investigational drugs, but it is critical to inform a more comprehensive evaluation of how drugs will affect a wider range of patients. People from different racial and ethnic backgrounds have unique genetic compositions. Therefore, one patient’s treatment resistance or response could be unlike another’s based on their individual genes. Increased diversity in clinical trial participation can potentially help reduce disparities in cancer survivorship.
Although this study looked at pancreatic cancer patients, the researchers believe their findings are likely applicable to clinical trials for other cancer types as they reflect common barriers that are not specific to pancreatic cancer.
Additional collaborators on this research include Nitai Mukhopadhyay, Ph.D., and Tamas Gal, Ph.D., research members at VCU Massey Cancer Center; Nevena Skoro, M.P.H., and Selamawit Girma, M.P.H., of Massey’s Cancer Informatics Core; Devon Freudenberger, M.D., and Vignesh Vudatha, M.D., of the VCU Department of Surgery; and Kelly Herremans, M.D., of the University of Florida College of Medicine.
This research was supported by the VCU Massey Cancer Center Cancer Informatics Core. Researchers were also supported by the National Human Genome Research Institute; the National Cancer Institute; the Joseph and Ann Matella Fund for Pancreatic Cancer Research; and, in part, by funding from Massey’s NIH-NCI Cancer Center Support Grant P30 CA016059.
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