“The importance of diverse representation cannot be underscored enough and is critical to ensure that safe and effective products are available to the [United States] patient population,” wrote the study authors, who were led by Nicole Gormley, MD.
In a paper published in Blood Cancer Discovery, working groups comprised of investigators, physicians, patients, statisticians, and regulators detailed steps that clinical trial sponsors and other stakeholders can take to improve the representation of African Americans in studies evaluating multiple myeloma indications.1
“The importance of diverse representation cannot be underscored enough and is critical to ensure that safe and effective products are available to the [United States] patient population,” wrote the study authors, who were led by Nicole Gormley, MD. “The current discrepancy between the percentage of patients diagnosed with [multiple myeloma] who are African American and the percentage enrolled in [multiple myeloma] clinical trials is troubling on many levels but can be addressed on multiple fronts.”
The working group recommended a number of changes to the design of preapproval clinical trials of drugs. The recommendations included:
Other recommendations detailed in the paper focused on gathering clinical trial data in the post-approval period. Studies conducted after the drug has entered clinical use could better inform myeloma therapeutics among racial and ethnic subpopulations with regard to safety and efficacy.
Moreover, the recommendations also detailed the importance of using existing real-world data for further assessment should the conduct of a randomized trial not be feasible. Real-world studies offer the ability to flag potential differences in outcomes and adverse effects for patient subgroups or to generate critical hypotheses for further evaluation.
“There hasn’t been as much progress in African Americans as there has been in other groups,” corresponding author Kenneth C. Anderson, MD, program director of the Lebow Institute for Myeloma Therapeutics and the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, said in a press release.2 “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.”
Of note, African Americans with multiple myeloma are not the only underrepresented and underserved population disproportionately affected by this disease. Therefore, the experts indicated that these recommendations should be generalized to other groups and diseases in an effort to improve both their representation in the drug development process and the understanding of each drugs performance in the population in which they will be used following regulatory approval.
“Our patients are truly the inspiration and heroes of this collaborative effort to eliminate the glaring issue of racial disparities in clinical trials,” added 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.”
1. Gormley N, Fashoyin-Aje L, Locke T, et al. Recommendations on eliminating racial disparities in multiple myeloma therapies: a step toward achieving equity in healthcare. Blood Cancer Discov. 2021;2:1-6. doi: 10.1158/2643-3230.BCD-20-0123
2. New recommendations aim to eliminate racial bias in myeloma trials. News release. Dana-Farber Cancer Institute. Published February 18, 2021. Accessed February 23, 2021. https://www.eurekalert.org/pub_releases/2021-02/dci-nra021721.php