Multiple myeloma can be a fatal disease. But if you are black or African American, you are particularly vulnerable. Research shows that you are more than twice as likely to be diagnosed with this blood cancer and die from it.

There are several reasons for this, but one concern is that blacks are not adequately represented in clinical trials. These are research studies that use human subjects to find out how safe and effective an experimental treatment is.

While Black people make up one-fifth of all people diagnosed with multiple myeloma, between 2003 and 2017 only 4.5 percent of people in multiple myeloma drug trials were Black. But it’s important that they are represented to better understand how they may be affected, says Nicole Gormley, MD, director of the FDA’s Division of Hematologic Malignancies 2. She is co-author of a research article on the topic.

“At the FDA, we use information obtained from clinical trials to understand the safety and effectiveness of drugs proposed to treat multiple myeloma,” Gormley says. “Diversity is needed in clinical trials so that we can 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, says Anne Quinn Young, MPH, chief mission officer of the Multiple Myeloma Research Foundation. They include:

Lack of information. Doctors play an important role when it comes to clinical trial enrollment. However, previous research has found that most black cancer patients, for example, say their doctors have never talked to them about the possibility of participating in a clinical trial.

“There’s a lot of implicit bias out there, meaning doctors have a lot of stereotypes or assumptions about their African-American patients that they don’t even realize,” Young says. A common one is that blacks will be less compliant with a study due to difficulties such as arranging transportation or medical care.

Distrust in the medical system. In the past, black people have been enrolled in clinical trials without their consent. An example is the infamous Tuskegee Syphilis Study, where patients were not offered available treatments. “As an African American physician, I understand the reluctance to participate in clinical trials based on historical injustices,” Gormley says. “But clinical trials often present patients with the best opportunity to receive cutting-edge therapy and advanced clinical care.”

Financial barriers. Research shows that people living in households earning less than $50,000 a year are 27 percent less likely to participate in clinical trials. The median family income for black households is approximately $40,000. Some treatments require you to take time off work from 2 weeks to a month, Quinn says. Other experimental treatments may require you to spend 48 to 72 hours in the hospital. That’s just not possible for some people, Quinn says, especially since days off from work and childcare are not covered by clinical trials. Additionally, some patients may have difficulty getting to enrollment sites for clinical trials, Gormley says.

Strict inclusion criteria. A study of 235 African American cancer patients found that fewer than 10 percent were eligible, and most patients were excluded for coexisting illnesses such as respiratory failure, HIV, or anemia. “There are also differences in laboratory values ​​such as hemoglobin. African Americans tend to have lower values ​​than (whites),’ Quinn says. As a result, they may be excluded from a trial simply because of normal laboratory differences due to race.

In April 2022, the FDA issued new draft guidance to drug developers on ways to develop plans that will include more minority participants in clinical trials.

“Addressing this problem will require a concerted effort from the entire community: physicians, industry, academia, patient advocacy groups and regulatory agencies,” Gormley says.

Some ways include:

Expand eligibility criteria. Some studies automatically reject patients with conditions such as high blood pressure and kidney disease. But black people are more likely to suffer from these diseases. If restrictions are relaxed, researchers can collect more data on certain racial and ethnic groups.

Require diversity curricula. This would mean that trial sponsors must complete a plan that establishes goals for enrolling a diverse set of patients. If it is not possible to do this during a trial, then they should plan to achieve that goal after the drug gains FDA approval.

Appoint diversity managers. They can help with trial design to ensure it includes disease subtypes and characteristics most commonly seen in black people, as well as recruitment. “It helps ensure a continued focus on diverse representation in clinical trials,” Gormley says.

Take advantage of community medical centers. Clinical trials are usually carried out in large academic and research centers in major cities. However, 70 to 80 percent of African Americans receive health care locally in their community, Quinn says. “The Multiple Myeloma Research Foundation has tried to reach these patients directly, through a research study known as CureCloud, to encourage them to enroll in clinical trials, and we have found that it doesn’t work,” Quinn says. “To convince them we need the help of their doctors.”

Provide financial assistance. Groups like the Multiple Myeloma Research Foundation have started initiatives to ensure that funding is available for things like childcare, transportation, and lack of work, so they are not barriers to participation, Quinn says.

Study the specific features of multiple myeloma unique to African Americans. A landmark study by the Multiple Myeloma Research Foundation known as the CoMMpass Study found that there are important differences in key cancer genes in African Americans with multiple myeloma. Certain genetic defects, for example, appear to explain why the disease is more common in African Americans. These genetic differences must be recognized and addressed during trials, Gormley says.