May 12, 2021
By Kayle Waterhouse
African Americans must be properly represented in clinical trials to ensure equal treatment for multiple myeloma and other cancers, top oncologists told SurvivorNet Connect.
Dr. Ajay Nooka, a hematologist-oncologist at the Winship Cancer Institute, says Blacks are underrepresented in clinical trials. He states that “20% of the patients that we treat for myeloma are Black, and when you see, of all the approved drugs that went to the registration trials, only 4.9% were representing the Black population.”
Dr. Luciano Costa, a hematologist-oncologist at the University of Alabama, provides insight on the underrepresentation on a greater scale. “The majority of trials that lead to registration of pharmaceuticals in the US are done mostly overseas. So that already, by itself, dilutes the representation of Black Americans in those clinical trials,” he says. Additionally, Dr. Costa and his colleagues looked at a US-based clinical trial stats and observed that “over half of the US-based clinical trials in myeloma didn’t even care to report race or ethnicity. Then, for the ones that did, the observed versus expected participation of Black patients was 0.5.”
Dr. Vincent Rajkumar, a hematologist-oncologist at the Mayo Clinic Cancer Center, worries that without adequate Black inclusion in trials, drug approvals could be unsafe. “There is a danger here that you are approving drugs with 2% or 3% of African-Americans in the whole trial… how are we sure that the dose is correct? How are we sure that the toxicity is the same? How are we even sure that the drug works in that population? We are not,” Dr. Rajkumar says.
Dr. Rajkumar says he’s asked the Food and Drug Administration (FDA) to implement clinical trial requirements for participation by race. This would include a mandate that least 10% of trial participants are Black in order to for a drug to be considered for approval.
Dr. Costa supports Dr. Rajkumar’s position on a mandate.”We have cohorts and subsets in our trials based on biological grounds and that’s totally acceptable. We have trials that have inclusion based on gender, we have trials that have inclusion based on age and we accept that,” he notes. “A racial subset is justifiable on the moral fairness grounds, but if you don’t want to go there, it’s justifiable under biological grounds.”
As a starting point, Dr. Brandon Blue, a hematologist-oncologist at Moffitt Cancer Center, recommends that oncologists and institutions be proactive at offering trials to Black patients.