On the path to eradicating racial bias in melanoma

New research published today in the American Association for Cancer Research journal Blood Cancer Discovery proposes an approach aimed to address racial discrepancies in clinical trials for multiple myeloma. Multiple myeloma is a blood cancer that reports a death rate twice as high in African Americans as compared to white Americans. The recommendations outlined in the paper from Dana-Farber Cancer Institute, the FDA, and AACR, intend to improve the representation of African American patients in clinical trials.

Although African Americans are more than twice as likely as white Americans to be diagnosed with multiple myeloma and to die from it, enrollment of African Americans in clinical trials has decreased by 3.5% in the last decade. African Americans account for 20% of people diagnosed with myeloma but made up only 4.5% of patients in new drug and biological license applications for myeloma from 2003-2017.

"There hasn't been as much progress in African Americans as there has been in other groups," says Kenneth C. Anderson, MD, the corresponding author of the study from Dana-Farber Cancer Institute. "The number of African Americans enrolled in clinical trials of novel agents or treatments of multiple myeloma has been tragically low. When they have enrolled, their outcome to treatment with novel therapies has been the same or even better than other patients," he commented.

The recommendations that the paper puts forth include the following, as reported by Dana Farber:

• “Broadening eligibility criteria whenever possible. For example, study criteria that reject patients with conditions like high blood pressure and kidney disease may disproportionately exclude African Americans. Including such patients may allow researchers to collect more data in racial and ethnic subpopulations.”
• “Requiring trial sponsors to complete a diversity study plan that sets targets for enrolling diverse participants.”
• “Appointing a diversity officer to assist with trial design and recruitment. Trial design should encompass disease subtypes and features most commonly seen in African Americans. Patients and patient advocates involved in the workshop strongly supported the recommendation of a diversity officer "to define strategies that support African American participation in clinical trials." The presence of a diversity officer "will hold researchers and industry accountable to conduct more inclusive and patient-centric trials," the recommendations stressed.”

The recommendations were developed at a workshop that took place last year and involved patients and patient advocates. "Our patients are truly the inspiration and heroes of this collaborative effort to eliminate the glaring issue of racial disparities in clinical trials," says Anderson. "If we can make clinical trials more inclusive and representative of real-world patients, we may not only enhance participation of African American patients, but also provide a paradigm for new drug development more broadly."

Sources: Blood Cancer Discovery, Dana Farber