Panelists discuss how historical underrepresentation of patients with darker skin tones in clinical trials has limited understanding of treatment efficacy and safety across diverse populations, hampering real-world clinical decision-making.
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Clinical trials in atopic dermatitis have historically underrepresented patients with darker skin tones, creating significant gaps in understanding treatment efficacy and safety across diverse populations. This underrepresentation has limited researchers’ ability to answer critical questions about variations in safety and efficacy profiles, differences in baseline characteristics and comorbidities, biomarker variations, and quality-of-life impacts across racial and ethnic groups. The lack of diverse representation has particularly hindered understanding of postinflammatory hyperpigmentation effects and other considerations specific to patients with skin of color.
The implications of this underrepresentation extend beyond academic interest to real-world clinical practice, where providers need confidence in treatment recommendations for their diverse patient populations. Without adequate clinical trial data reflecting the demographics of actual patient populations, clinicians have been forced to extrapolate efficacy and safety data from study participants with lighter skin tones to their patients with darker skin tones.
Andrew Alexis, MD, MPH, notes that the field has reached an “inflection point” with newer clinical trials specifically designed to include adequate representation of patients with skin of color. This shift represents a crucial advancement in dermatologic research methodology and promises to provide the evidence base necessary for confident treatment recommendations across all patient populations. The movement toward more inclusive clinical trials reflect growing recognition that medication responses may vary across different populations and that representative data are essential for equitable health care delivery.
Managed Care Reflections: A Q&A With A. Mark Fendrick, MD, and Michael E. Chernew, PhD
December 2nd 2025To mark the 30th anniversary of The American Journal of Managed Care (AJMC), each issue in 2025 includes a special feature: reflections from a thought leader on what has changed—and what has not—over the past 3 decades and what’s next for managed care. The December issue features a conversation with AJMC Co–Editors in Chief A. Mark Fendrick, MD, director of the Center for Value-Based Insurance Design and a professor at the University of Michigan in Ann Arbor; and Michael E. Chernew, PhD, the Leonard D. Schaeffer Professor of Health Care Policy and the director of the Healthcare Markets and Regulation Lab at Harvard Medical School in Boston, Massachusetts.
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