Multiple myeloma can be a fatal disease. But if you are Black or African American, you are especially vulnerable. Research shows that you are more than twice as likely to be diagnosed with and die from this blood cancer.
There are several reasons for this, but one concern is that Black people are not adequately represented in clinical trials. These are research studies that use humans to find out how safe and effective experimental treatments are.
One in five people diagnosed with multiple myeloma are black, but between 2003 and 2017, only 4.5 percent of multiple myeloma trials were black. But Nicole Gormley, M.D., chief of the FDA's Division of Hematologic Malignancies, said she was willing to represent them to better understand how they might be affected. states that it is important. She is a co-author of a research paper on this topic.
“FDA uses information learned from clinical trials to understand the safety and effectiveness of drugs proposed to treat multiple myeloma,” Gormley says. “Diversity in clinical trials is needed to learn the activity and side effects of these products in all patients who may ultimately receive the drug.”
There are several reasons why Black people are less likely to participate in clinical trials, said Anne Quinn Young, MPH, chief mission officer at the Multiple Myeloma Research Foundation. They include:
Lack of information. Physicians play a big role when it comes to enrollment in clinical trials. But past research has shown that most black female cancer patients, for example, have never been approached by a doctor about potentially participating in a clinical trial.
„There's a lot of implicit bias out there, which means doctors have a lot of stereotypes and assumptions about African-American patients that they don't even realize they have,“ Young says. Often, black people are less likely to participate in research because they have difficulty arranging transportation and medical care.
Distrust in the medical system. In the past, black people have participated in clinical trials without their consent. One example is the infamous Tuskegee Syphilis Study, which provided no available treatment to patients. „As an African American physician, I understand the reluctance to participate in clinical trials based on historical injustices,“ Gormley said. “However, clinical trials are often the best opportunity for patients to receive cutting-edge treatments and advanced clinical care.”
Economic barriers. Studies have shown that people living in households with an annual income of less than $50,000 are 27 percent less likely to participate in clinical trials. The median household income for Black households is approximately $40,000. Depending on the treatment, people may need to take time off from work for two weeks to a month, Quinn said. Other experimental treatments may require hospitalization for 48 to 72 hours. Quinn said that's not possible for some people, especially since time off from work or childcare is not covered in clinical trials. Additionally, some patients may have trouble getting to a clinical trial registration site, Gormley said.
Strict inclusion criteria. One study of 235 African American cancer patients found that fewer than 10 percent were included, with most patients excluded due to comorbidities such as respiratory failure, HIV, and anemia. It has been found. „There are also differences in test values such as hemoglobin. African Americans tend to have lower values than (white) people,“ Quinn says. As a result, they may be excluded from clinical trials simply because of routine laboratory differences based on race.
In April 2022, the FDA issued new draft guidelines for drug developers on how to plan to include more minority participants in clinical trials.
„Addressing this issue will require a concerted effort from the entire community, including physicians, industry, academia, patient advocacy groups, and regulators,“ Gormley said.
Some methods include:
Expand eligibility criteria. Some studies automatically reject patients with medical conditions such as high blood pressure or kidney disease. However, black people are more likely to contract these diseases. Easing restrictions would allow researchers to collect more data on specific racial and ethnic groups.
Request a diversity learning plan. This means trial sponsors must complete targeted plans to enroll diverse patients. If this is not possible during the clinical trial, a plan must be developed to achieve that goal after the drug receives FDA approval.
Appoint a diversity officer. They will assist with trial design and recruitment to ensure trials include disease subtypes and characteristics most commonly seen in Black people. “It helps us continue to focus on diverse representation in clinical trials,” Gormley says.
Use community-based medical centers. Clinical trials are often conducted in large research or academic centers located in large cities. But Quinn said his 70 to 80 percent of African Americans receive treatment locally in the community. „The Multiple Myeloma Research Foundation has attempted to reach these patients directly through a research study known as CureCloud to encourage enrollment in clinical trials, but we have found that to be unsuccessful.“ Quinn says. „We need a doctor's help to convince them.“
Provide financial assistance. Quinn said organizations such as the Multiple Myeloma Research Foundation are working to secure funding to ensure that child care, transportation and missed work are no longer barriers to participation.
Study the characteristics of multiple myeloma that are unique to African Americans. A groundbreaking study conducted by the Multiple Myeloma Research Foundation, known as the CoMMpass study, found important differences in key cancer genes in African Americans with multiple myeloma. For example, certain genetic defects appear to explain why the disease is more common in African Americans. Gormley says these genetic differences need to be recognized and addressed during clinical trials.