In a collaborative effort, researchers from the Dana-Farber Cancer Institute, the U.S. Food and Drug Administration (FDA), and the American Association for Cancer Research (AACR) released their recommendations for increasing the representation of African American patients in clinical trials for multiple myeloma (MM).
The new recommendations were published in Blood Cancer Discovery.
Despite literature establishing a higher risk of MM for African Americans, this population is notably underrepresented in clinical trials for novel treatments for this malignancy.
“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,” said co-author Kenneth C. Anderson, MD, medical oncologist at Dana-Farber and program director of the Lebow Institute for Myeloma Therapeutics and the Jerome Lipper Multiple Myeloma Center, in a press release.
To develop these recommendations, researchers, providers, patients, and industry partners came together with regulators at an FDA-AACR sponsored workshop to outline a “roadmap” to improved enrollment.
Suggestions for increasing representation of African Americans in these trials include:
- Broadening eligibility criteria whenever possible;
- Requiring trial sponsors to complete diversity study plans to set enrollment targets;
- Appointing a diversity officer to aid with trial design and recruitment;
- Continuing to gather data on racial and ethnic differences in treatment safety and efficacy during the post-approval period.
“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,” Dr. Anderson said.
Science in Society— FDA-AACR Recommendations on Eliminating Racial Disparities in Multiple #Myeloma Therapies: A Step toward Achieving Equity in Healthcare. @FDAOncology @AACR @fredhutch @theNCI @EmoryMedicine @DanaFarberNews https://t.co/uL5xm7ABJB pic.twitter.com/LEFlxT1BdI
— Blood Cancer Discovery (@BCD_AACR) February 18, 2021
FDAOncology’s @pkluetz @LolaFashoyinAje and Dr. Nicole Gormley participated in the Feb 2020 FDA-@AACR workshop to develop recommendations to improve representation of African Americans in multiple myeloma clinical trials. @BCD_AACR https://t.co/Z6sN85K6zS https://t.co/FipsZFY3mD
— FDA Oncology (@FDAOncology) February 18, 2021