En español | African Americans are hit harder than any other group by the blood cancer multiple myeloma. Yet the already small percentage of Black patients enrolled in clinical studies of this disease has dropped.
Researchers say this disparity needs to be reversed, and they've released recommendations designed to address the issue in an article published in the American Association for Cancer Research (AACR) journal Blood Cancer Discovery.
Between 2003 and 2017, there was a 3.5 percent decrease in the number of African Americans enrolled in studies related to multiple myeloma, a disease that is twice as deadly for Blacks as for whites. This rare and incurable blood cancer accounts for just 2 percent of all cancers but is the most common blood cancer among Blacks.
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"The number of African Americans enrolled in clinical trials of novel agents or treatments of multiple myeloma has been tragically low,” says study corresponding author Kenneth C. Anderson, M.D., program director of the Dana-Farber Cancer Institute's LeBow Institute for Myeloma Therapeutics and the Jerome Lipper Multiple Myeloma Center. “When they have enrolled, their outcome to treatment with novel therapies has been the same or even better than other patients.”
Adoption of recommendations needed
Researchers from the AACR, the U.S. Food and Drug Administration and Harvard Medical School's Dana-Farber Cancer Institute found that only 4.5 percent of patients in clinical trials for myeloma treatments were African Americans. However, African Americans make up about 20 percent of the 30,000 Americans diagnosed each year with the blood cancer.
The disease claims an estimated 5.6 deaths per 100,000 African Americans annually, compared with 2.4 deaths per 100,000 whites.
The researchers say the racial disparity found in clinical trials is concerning because the results may not properly reflect underlying genetic and biological differences that have been discovered between African American and white myeloma patients.
They point in particular to disparities in trials for novel therapies — an area of promise for this presently incurable disease, as studies have found improved outcomes in recent years for patients diagnosed with multiple myeloma.
Among the recommendations offered by the researchers:
- Broaden eligibility criteria for clinical trials. Set diversity targets for trials and, when possible, avoid rejecting patients from clinical trials with underlying conditions such as high blood pressure or kidney disease that disproportionately impact African Americans.
- Appoint a diversity officer to assist with trial design and recruitment.
- Engage with advocacy groups to build trust and encourage participation in trials and studies.
- Devise strategies to overcome clinical, social and socioeconomic impediments to trial access.
- Incentivize inclusiveness through funding, regulation or legislation as has been done for other types of trials, including for orphan drugs.
The study concludes by emphasizing the need to include those most impacted by multiple myeloma in studies and trials.
"The importance of diverse representation cannot be underscored enough and is critical to ensure that safe and effective products are available to the U.S. patient populations,” the researchers wrote in the report. They added that the goal was for the recommendations to “lead to a more inclusive ‘real-world’ drug development paradigm."