Richmond, Va. — According to a study published today in Gastroenterology by researchers at Virginia Commonwealth University Massey Cancer Center and University of Florida Health, Black, Hispanic, Indigenous and Asian Americans remain conspicuously absent from pancreatic cancer clinical trials aimed at testing the most recent treatment advances for this deadly disease.
Not only does this lack of diversity hurt patients belonging to these minority groups – who already shoulder a disproportionate pancreatic cancer burden – but it hurts science too.
“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, M.D., surgeon-in-chief at VCU Massey Cancer Center, chair of surgical oncology at the VCU School of Medicine and associate professor of surgery. “We could be throwing away a really good treatment option for racial and ethnic minority patients.”
For this study, Trevino and colleagues searched the clinicaltrials.gov database for pancreatic cancer treatment trials conducted in the U.S. between 2005 - 2020. Since demographics aren’t typically reported during recruitment, the researchers focused on trials with results – a total of 207 trials, with 8,429 participants altogether.
These data revealed that over the last 15 years, there has been a steady increase in the proportion of pancreatic cancer trials reporting participants’ race and ethnicity, with a sizeable bump after reporting became federally mandated in 2017. In 2020, all of the trials included in this study reported the race and ethnicity of participants.
Yet, the actual inclusion of racial and ethnic minorities has stayed flat over time, stuck at the same disproportionately low rates for more than a decade.
“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 study lead author Kelly Herremans, M.D., a surgical resident at the University of Florida College of Medicine. “I find that shocking.”
During the study period, only 8% of pancreatic cancer clinical trial participants were Black, even though 12% of pancreatic cancer cases occur among the Black community. Likewise, Hispanic patients make up 6% of trial participants but 9% of cases, Asians account for 2% of trial participants but 3% of cases and Indigenous Americans make up 0.3% of trial participants but 0.4% of cases.
The researchers attribute this lack of diversity to several factors, including mistrust of the medical establishment, implicit bias among clinicians, strict clinical trial inclusion criteria and lack of diversity among the clinicians who are recruiting patients to trials. The paper lays out concrete steps to address these issues.
For instance, the authors challenge the idea that hypertension, diabetes and HIV – chronic diseases more common among Black, Hispanic and Indigenous American communities – should automatically exclude a person from a cancer trial, so long as symptoms are well controlled.
“There are a ton of obstacles to get these patients into clinical trials,” said Trevino, who also holds the Walter Lawrence, Jr., Distinguished Professorship of Oncology at VCU. “But this is how we’re going to understand the disease better. And it’s critically important for the future of cancer health disparities.”
Additional authors on the study include Andrea Riner, M.D., M.P.H., a surgical resident at the UF College of Medicine; and Robert Winn, M.D., director and Lipman Chair in Oncology at VCU Massey Cancer Center.
Funding for this research was provided by the National Human Genome Research Institute (grant T32 HG008958), the National Cancer Institute (grant R01CA242003) and the Joseph and Ann Matella Fund for Pancreatic Cancer Research.
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About VCU Massey Cancer Center
VCU Massey Cancer Center is working toward a future without cancer – one discovery, one successful therapy and one life saved at a time. Among the top 4 percent of cancer centers in the country to be designated by the National Cancer Institute to lead and shape America’s cancer research efforts, Massey is dedicated to saving and improving lives by discovering, developing, delivering and teaching effective means to prevent, detect and treat cancer and to making those advancements equally available to all. Massey is leading the nation in establishing a 21st-century model of equity for cancer research and care, in which the community is informing and partnering with Massey on its research to best address the cancer burden and disparities of those the cancer center serves. Massey conducts cancer research spanning basic, translational, clinical and population sciences; offers state-of-the-art cancer therapies and clinical trials, including a network that brings trials to communities statewide; provides oncology education, teaching and training; and promotes cancer prevention. At Massey, subspecialized oncology experts collaborate in multidisciplinary teams to provide award-winning, comprehensive cancer care at multiple sites throughout Virginia. Visit Massey online at masseycancercenter.org or call 877-4-MASSEY for more information.
About UF Health
UF Health is a world-class academic health center that combines leading-edge research at campuses around Florida with outstanding clinical care at a network of hospitals around the state. The flagship is UF Health Shands Hospital, ranked the No. 1 hospital in Florida in the 2020-21 U.S. News & World Report Best Hospitals survey, with nine adult and three pediatric specialties in the top 50 in the nation, more than any other hospital in Florida.
With main campuses in Gainesville and Jacksonville as well as satellite sites in Central Florida and several other locations, UF Health provides exemplary health care to patients across the third-most populous state in the nation. UF Health consists of six health colleges, nine research centers and institutes,10 hospitals — including two teaching hospitals and five specialty hospitals — and a host of physician medical practices and outpatient services.
The backbone of UF Health is a talented and dedicated workforce of more than 33,000 people who provide lifesaving care and research breakthroughs for more than 3 million patients who come to UF Health each year from around the U.S. and more than 30 countries.
UF Health is committed to improving lives and health through a variety of community-based programs and activities. As part of the state’s “safety-net’’ hospital system, caring for people who have little or no medical coverage, UF Health provided more than $254.9 million in unsupported charity care and social responsibility across its Gainesville and Jacksonville campuses in fiscal year 2019. Annually, UF Health contributes more than $4.6 billion to Florida’s overall economy.
Our mission is to promote health through outstanding and high-quality patient care, innovative and rigorous education in the health professions and biomedical sciences, and high-impact research across the spectrum of basic, translational and clinical investigation. Visit www.UFHealth.org to learn more.
Method of Research
Subject of Research
Diversity and Inclusion in Pancreatic Cancer Clinical Trials
Article Publication Date
The authors have no conflicts of interest to disclose