In a workshop conducted by the FDA and the AACR, working groups came together to address disparities in the representation of African Americans in multiple myeloma clinical trials and to create a set of recommendations in an attempt resolve them.
The FDA, in partnership with the American Association for Cancer Research (AACR), held a workshop on February 13, 2019 in Wardman Park, Washington D.C. to examine the under-representation of African Americans in multiple myeloma trials.1
“To address disparities in cancer care, it is important to consider the entire scope of clinical development,” Lola A. Fashoyin-Aje, MD, MPH, acting deputy director of the Division of Oncology 3 at the Office of Oncologic Diseases, said in a press release.2 “Our hope is that incorporating these recommendations early and throughout clinical development programs will lead to better outcomes for African American patients with multiple myeloma and other populations traditionally underrepresented in clinical trials.”
Recommendations were given by 3 separate working groups on how to better obtain data on racial and ethnic minorities in order to better inform the FDA’s assessment of safety and efficacy prior to the approval of new therapeutic treatments for multiple myeloma, understand the effectiveness and safety of therapies in racial and ethnic minorities, and utilize real-world data to inherently understand the outcomes.
Some of the recommendations provided by the working groups, which consisted of physicians, researchers, and industry professionals, included:
Craig E. Cole, MD, from the Michigan State University Breslin Cancer Center, who presented the first set of recommendations, added, “Editors and reviewers for papers should demand change and demand ethnicity in enrollment criteria for their papers and the idea was that if editors and reviewers demanded change, then the researchers will have to follow, so I think that’s an important point.”
Notably, Fashoyin-Aje specified that “the FDA does not have the regulatory or statutory authority to require that sponsors include demographic subgroups as participants in clinical trials.”
1. FDA-AACR Workshop to Examine Under-representation of African Americans in Multiple Myeloma Clinical Trials. Held Feb. 13, 2020. Wardman Park, Washington D.C.
2. FDA-AACR Workshop to Address Multiple Myeloma Clinical Trial Disparities [news release]. AACR. Published February 4, 2020. aacr.org/professionals/blog/fda-aacr-workshop-to-address-multiple-myeloma-clinical-trial-disparities/. Accessed February 13, 2020.