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Guidance Offered for Improving Diversity in Multiple Myeloma Trials

WEDNESDAY, March 10, 2021 -- In an initiative from the Dana-Farber Cancer Institute in Boston, the U.S. Food and Drug Administration, and the American Association for Cancer Research, published online Feb. 18 in Blood Cancer Discovery, recommendations are presented for increasing representation of African Americans in clinical trials of multiple myeloma (MM).

Noting that African Americans are at higher risk for MM but are underrepresented in clinical trials and are not benefiting from advances in treatment, Nicole Gormley, M.D., from the U.S. Food and Drug Administration in Silver Spring, Maryland, and colleagues developed recommendations to improve their representation in trials.

The authors recommend broadening eligibility criteria for trials, including considering expansion cohorts with broader eligibility criteria within registration trials. Furthermore, trial sponsors should complete a diversity study plan, which sets targets for trial enrollment based on disease epidemiology that aim to meet predetermined diversity targets and include plans for meeting the target in the postapproval setting; prespecifies analyses and end points to be assessed in racial subgroups; outlines strategies for enrollment and retention of a diverse population within the trial; and shares examples of strategies that help meet target enrollment. A diversity officer can be appointed to phase II and III clinical trials to assist with design and recruitment strategies. Trial design should include disease subtypes and features that are mainly seen in African-American patients.

"The current discrepancy between the percentage of patients diagnosed with MM who are African American and the percentage enrolled in MM clinical trials is troubling on many levels but can be addressed on multiple fronts," the authors write.

Several authors disclosed financial ties to the pharmaceutical industry.

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