The importance of diversity in clinical trials has been a topic of discussion for many years. Without diverse representation, we do not know how the many drugs, medical devices, and treatment plans born out of clinical trials will affect diverse groups. People of color continue to be underrepresented in clinical studies, which limits their access to cutting-edge treatments. It also restricts the gathering of medical data that could help support the health and wellness of minority communities.
The Division of Pediatric Allergy and Immunology at Johns Hopkins University School of Medicine studied how the seminal randomized controlled trials (RCT) for benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab were lacking in representation of diverse groups. They argued that these underrepresented groups are prevalent in everyday practice, and so there may be discrepancies between the efficacy of these drugs in the studies and their effectiveness in real life.
The researchers extracted data about the trial participants from the medication guides for these drugs and from peer-reviewed journals. They then compared this data against data from the 2005-2012 National Health and Nutrition Examination Survey (NHANES) to generate a nationally representative sample. In comparison to the NHANES, the RCTs were found to be significantly lacking in child, female, and Black participants and participants who smoked or had obesity. Moreover, only one-third of the RCTs studied reported including Hispanic participants.
The researchers ultimately concluded that participants enrolled in RCTs studying the use of biologics to treat severe, uncontrolled asthma were older, more likely to be Caucasian, have never smoked, and have lower BMIs compared with a nationally representative sample of participants with uncontrolled asthma. These findings suggest that given the studies’ lack of representation of diverse groups, the estimated treatment effect size of these biologic medicines may be skewed [1].
Source:
[1] Akenroye, A., & Keet, C. (2020). Underrepresentation of blacks, smokers, and obese patients in studies of monoclonal antibodies for asthma. The Journal of Allergy and Clinical Immunology: In Practice, 8(2), 739-741.e6. https://doi.org/10.1016/j.jaip.2019.08.023
