Underrepresentation of patients with skin of color in clinical trials is an issue in medical research, including in research about dermatological conditions. A study in the January Journal of Drugs in Dermatology looked at the diversity of patients enrolled in melasma clinical trials to determine if there are any disparities in representation.
I interviewed author Jared Jagdeo, MD, MS, associate professor of dermatology and director of the Center for Photomedicine at SUNY Downstate Medical Center.
What led you to investigate representation in clinical trials about melasma?
Our interest in analyzing representation in melasma clinical trials arose from evidence showing that melasma disproportionately affects individuals with darker skin tones — groups that are historically underrepresented in dermatological research. At the same time, there was a clear gap in understanding gender, race, and Fitzpatrick skin type (FST) representation in melasma trials. By examining demographic data within melasma trials, we aimed to uncover any disparities in representation and ultimately improve research and treatment strategies for the populations most affected by this condition.
How did you conduct your research?
We utilized the U.S. National Library of Medicine’s ClinicalTrials.gov database to identify trials focusing on melasma. We specifically looked for completed trials and analyzed available data on participant demographics, including gender, race, and Fitzpatrick skin types.
Before you conducted your investigation, what did you think you would find? Did the results affirm or negate your hypothesis? Were any of the results surprising?
We initially hypothesized that we would find an underrepresentation of skin of color populations, given the traditional underrepresentation of these groups in clinical trials across other dermatological conditions. However, the results were somewhat unexpected as they showed a substantial representation of skin of color populations in melasma trials. This was a positive finding that contrasted with the previously identified underrepresentation of skin of color patients across other dermatological conditions.
How do gender, race, and skin type representation in melasma clinical trials compare to the known prevalence of the disease?
Overall, the demographic breakdown in melasma trials aligns closely with what is known about melasma prevalence. Melasma predominantly affects women and is more prevalent among certain racial and ethnic groups, which were adequately represented in the trials we analyzed.
What groups, if any, should be more represented in melasma clinical trials?
Based on our analysis, participants from different ethnic backgrounds, skin types, and genders are generally well-represented in melasma clinical trials. This inclusion reflects a deliberate effort to include those populations most affected by the condition, thereby improving the real-world applicability of study findings. While current trials show robust representation, continued attention to maintaining inclusivity across all demographics will help ensure that future research remains both equitable and comprehensive.
What advice do you have for researchers conducting clinical trials about conditions that primarily affect people with skin of color in ensuring a study population that is representative of those affected?
Researchers should prioritize the inclusion of patients across diverse racial and ethnic groups, particularly for conditions known to be disproportionately affected by skin of color populations. Such representation in clinical trials is essential because it ensures the efficacy and safety of treatments across diverse populations. Engaging with community organizations, addressing cultural or logistical barriers to participation, and highlighting the importance of inclusive research are all strategies that can enhance representation and improve the real-world relevance of trial outcomes.
What advice do you have for researchers in what demographic data, such as race, ethnicity, and skin type, should be obtained from study participants? How may a researcher best categorize this data so that representation in studies may be compared?
It’s critical for researchers to collect detailed demographic data using standardized categories for race, ethnicity, and skin type. Clear and consistent categorization allows for accurate comparisons across studies and can help identify trends and gaps in research.
Are there any other key takeaways from your study?
One of the main takeaways is the importance of inclusivity in clinical research; it not only strengthens the validity of clinical trial findings but also ensures that the treatments developed are safe and effective for everyone affected by a condition. While our study demonstrates progress in this area for melasma research, ongoing efforts to maintain broad representation remain essential to advancing equitable care in dermatology.
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