(Press-News.org) (WASHINGTON, May 4, 2023) – Numerous studies have shown that people from racial and ethnic minority groups are underrepresented in clinical trials of new medical treatments for multiple myeloma. A study published today in Blood suggests that, for clinical trials of new treatments for multiple myeloma (a type of blood cancer), one reason for this underrepresentation may be that the parameters set to determine who can – and cannot – enroll in trials disproportionately exclude minority patients.
“Our study suggests that, in multiple myeloma clinical trials, some eligibility criteria specified in trial protocols may be contributing to racial and ethnic disparities in enrollment,” said Bindu Kanapuru, MD, a medical officer with the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and first author of the study. “We found that, compared with white patients, those who were Black or of other races (American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders) were more likely to be deemed ineligible for trial enrollment.”
All clinical trials set criteria that patients must satisfy to enroll, she said. For example, patients may be required to have already been treated unsuccessfully with specific medications, received a minimum number of prior treatments, have blood cell counts above or below a specified level, or not have other health conditions such as heart disease or a history of asthma.
“To our knowledge, this is the first study to evaluate trial eligibility criteria as a potential barrier to the enrollment of patients from underrepresented racial and ethnic subgroups into clinical trials for multiple myeloma,” Dr. Kanapuru said.
Multiple myeloma is the second most common type of blood cancer in the United States, with about 34,500 new cases diagnosed in 2022, she said. In the United States, Black people are twice as likely as whites to be diagnosed with multiple myeloma and have the highest rates of death from the disease, followed by American Indians and Alaska Natives. Yet Black patients comprise less than 5% of those enrolled in clinical trials that are intended to lead to the approval of new treatments for multiple myeloma, Dr. Kanapuru said, while the proportion of American Indians and Alaska Natives who are enrolled is even smaller.
For this study, she and her colleagues analyzed information submitted to the FDA for 9,325 patients who were evaluated for enrollment in 16 clinical trials of novel treatments for multiple myeloma that were performed between 2006 and 2019. Twelve percent of the patients were evaluated in the United States and 88% in other countries. Eighty-three percent of the patients were white, 7% Asian, 4% Black, 4% of unknown race, and 2% of “other” races (which included American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders). Four percent of patients reported being of Hispanic ethnicity.
Overall, 17% of the evaluated patients were deemed ineligible for trial enrollment. The ineligibility rate was highest for Black patients (24%), followed by those of ‘other’ races (23%). Seventeen percent of white patients were deemed ineligible. Patients of Asian heritage had the lowest rate of ineligibility (11%). Black patients were most likely to be considered ineligible because of their blood cell counts or because they had not previously received specific treatments or a minimum number of prior treatments. White patients were most likely to be ineligible due to not meeting specific disease-related criteria.
“Previous studies in patients with multiple myeloma have shown that ‘normal’ levels of neutrophils (a type of white blood cell) may be lower among Black patients than whites and that Black patients have higher rates of anemia (a shortage of red blood cells) than whites,” Dr. Kanapuru said. “This suggests that trials should set criteria for blood counts that take racial and ethnic variations into account.”
Other studies, she said, have shown that Black patients with multiple myeloma are less likely to receive certain standard therapies. “This can result in a cycle in which Black patients aren’t enrolled in trials because they haven’t previously received certain treatments, which in turn means there’s a lack of evidence to show whether or not those treatments are effective in Black patients.”
One notable finding from the current study is that a subset of Black patients were enrolled in trials despite not meeting some of the eligibility criteria such as low blood counts, said Dr. Kanapuru. “This suggests that some physicians may already be factoring in racial and ethnic variations in things like blood counts when they evaluate patients for trial eligibility,” she said. “While this is encouraging, the actions of individual physicians are unlikely to be enough to solve the problem of racial and ethnic disparities in trial enrollment.”
The FDA has published guidance for industry on strategies for increasing the enrollment of underrepresented racial and ethnic groups in clinical trials, she said.
A limitation of the study findings, she said, is that because so few patients from racial and ethnic minorities were evaluated for trial enrollment, the researchers could not perform a rigorous statistical analysis to determine with greater precision why patients were deemed ineligible.
“The very small numbers of minority patients who were evaluated makes it impossible for us to draw definitive conclusions,” she said. “However, we hope that our study will raise awareness of this issue.”
# # #
In 2021, the American Society of Hematology (ASH) issued a statement addressing diversity, equity, and inclusion in hematology research, practice, and training, and the Society continues to engage with key federal and non-federal stakeholders about the importance of promoting diversity in hematologic trials.
Blood (www.bloodjournal.org), the most cited peer-reviewed publication in the field of hematology, is available weekly in print and online. Blood is a journal of the American Society of Hematology (ASH) (www.hematology.org).
Contact:
Kira Sampson, American Society of Hematology
ksampson@hematology.org; 202-499-1796
END
PHILADELPHIA — (MAY 4, 2023) — The p53 gene is one of the most important in the human genome: the only role of the p53 protein that this gene encodes is to sense when a tumor is forming and to kill it. While the gene was discovered more than four decades ago, researchers have so far been unsuccessful at determining exactly how it works. Now, in a recent study published in Cancer Discovery, a journal of the American Association for Cancer Research, researchers at The Wistar Institute have uncovered a key mechanism ...
A pilot project for energy self-sufficient schools is now starting in the County of Friesland, Northern Germany, in which school buildings will be equipped with vertical-axis wind turbines. This will be facilitated by a research group led by Professor Uygun from Constructor University. This group is studying and developing vertical wind turbines, which will be produced in its own 3D printer on the campus in Bremen and will be tested in practice within this project. This creates a fully functional test field that provides important data and experience for technology transfer.
In the current energy ...
Monash University researchers have discovered a key mechanism in the body’s immune system that helps control the inflammatory response to infection. The discovery could help pave the way for more targeted therapies in a range of inflammatory conditions, such as autoimmunity and neuroinflammatory disease.
The innate immune system is the body’s first line of defence against pathogens. Innate immune proteins detect foreign bodies such as bacteria and viruses and respond by mounting a protective inflammatory ...
There’s no question that watermelon is both delicious and nutritious, but new research underscores this nutrient-rich fruit’s contributions to overall diet quality and heart health.
A recent study published in Nutrients suggests that watermelon can increase nutrient intake and overall diet quality in both children and adults.1 The study analyzed National Health and Nutrition Examination Survey (NHANES) data and found that total diet quality was higher in watermelon consumers as compared to non-consumers. ...
PLYMOUTH MEETING, PA [May 4, 2023] —The National Comprehensive Cancer Network® (NCCN®) has announced the 2023 recipients of awards honoring individuals who made a remarkable difference in improving the lives of people with cancer over the past year.
2023 NCCN Award Recipients:
Theresa J. Franco, MSN, RN, Vice President, Cancer Clinical Operations, Nebraska Medicine
NCCN Board of Producers Award recipient for exemplary service of NCCN’s mission
F. Marc Stewart, MD, Professor, Vice Chair, Department of Hematology and ...
DALLAS, May 4, 2023 — A recent study revealed that, in the United States, Black and Latinx entrepreneurs receive only 2.6% of venture capital investment. [1] The American Heart Association®, the world’s leading nonprofit organization focused on longer, healthier lives for all, has opened the application window for submissions to the EmPOWERED to Serve Business Accelerator™. The Accelerator program has been established to support local communities, small businesses, social entrepreneurs and innovators who are working to increase health equity and create groundbreaking social change at the zip code level.
Now in its seventh year, the Business ...
In Florida alone, thousands of acres of marine seagrass beds have died. Major seagrass die-offs also are occurring around the world. Stressors such as high temperature, hypersalinity and hypoxia or lack of oxygen affect seagrasses’ ability to resist and recover from these stressor-related mortality events or when disturbances lead to seagrass die-off events.
Seagrass die-offs also are linked to exposure to sediment-derived hydrogen sulfide, a well-known phytotoxin that accumulates as seagrass ecosystems become more enriched in nutrients. While hydrogen sulfide intrusion into seagrass tissue is considered a leading cause of recurring mortality ...
In 2019, scientists in the joint School of Engineering and School of Life Sciences Laboratory of Protein Design and Immunoengineering (LPDI) led by Bruno Correia developed MaSIF: a machine learning-driven method for scanning millions of protein surfaces within minutes to analyze their structure and functional properties. The researchers’ ultimate goal was to computationally design protein interactions by finding optimal matches between molecules based on their surface chemical and geometric ‘fingerprints’.
Four years later, they have achieved ...
Genome editing is used to modify the genes of living organisms to elicit certain traits, such as climate-resilient crops or treating human disease at the genetic level. It has become increasingly popular in agriculture, medicine and basic science research over the past decade, and will continue to be relevant and utilized well into the future. Given this prevalence, researchers at the University of California San Diego have started an outreach program that introduces genome-editing technologies to high school students.
Assistant Professor of Chemistry and Biochemistry Alexis Komor, and Ph.D. candidates Mallory ...
DALLAS, May 4, 2023 — Teams of research scientists from three universities will lead an innovative $15 million project to study the biological mechanisms of chronic stress that can increase cardiovascular disease risk. The Strategically Focused Research Network (SFRN) on Biologic Pathways of Chronic Psychosocial Stressors on Cardiovascular Health of the American Heart Association, the world’s leading voluntary organization dedicated to a world of longer, healthier lives, will focus on learning more about how the body responds to chronic stress, as well as how certain interventions may help reduce health risks.
Chronic stress is recognized as an independent ...