In order to ensure that individuals of all genders, races, and ethnicities receive the best possible health care — taking into account known and potential differences between and among various populations — it is important for research on diseases and conditions to include diverse participants. This extends to clinical trials of medications.
Now a new study in JAMA Oncology has shown that clinical trials for new cancer medications rarely analyze data on safety and effectiveness by race. In addition, the study found that black and Hispanic patients are consistently underrepresented among participants compared to their relative proportion of cancer incidences in the general U.S. population.
This study, published Aug. 15, follows earlier research findings that women are underrepresented in studies of cancer, certain types of heart disease, and HIV. A 2016 study conducted by WHRY and the University of California, San Francisco also found that few medical devices are assessed by sex and gender with regard to safety and effectiveness.
“People inherently have biological differences, and these differences can have significant consequences for health and disease,” said Dr. Carolyn M. Mazure, Director of Women’s Health Research at Yale. “In 2019, we are long past the point where we should be arguing about this truth. Now we must make sure that all research explores sex, gender, race, and ethnicity and analyzes the data so that we can establish safe and effective standards of care for everyone.”
We must make sure that all research explores sex, gender, race, and ethnicity so that we can establish safe and effective standards of care for everyone.
Dr. Carolyn M. Mazure
Of the 230 trials for oncology drugs approved by the U.S. Food and Drug Administration (FDA) between 2008 and 2018, only 8 percent reported data on all four major racial groups in the United States (white, Asian, black, and Hispanic), according to the new study. In addition, only 25 percent of the studies included analysis of potential racial differences in the findings.
Among the clinical trials examined, researchers compared the percentage of participants from each racial subgroup who were included in the trials compared with the general US incidence of cancer for that subgroup. Researchers found that only 22 percent of the expected number of black participants and only 44 percent of the expected number of Hispanic participants were included in trials. In contrast, white participants were represented at similar levels to the larger population (98 percent), and Asian participants were overrepresented by more than four times compared to the general population of cancer patients.
The National Institutes of Health (NIH) requires that research receiving the agency’s grants include information about sex/gender and race/ethnicity of participants. Pharmaceutical companies submitting data for approval of new medications should also provide representative data in reference to sex/gender and race/ethnicity, and this should be enforced by the U.S. Food and Drug Administration.