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Dr Robert Dellavalle Discusses the Importance of Diversity in Clinical Trials


Unless all populations are represented adequately in trials, it will be hard to know if a drug works the same in all populations as it does in one specific one, explained Robert Dellavalle, MD, PhD, MSPH, of University of Colorado School of Medicine and Rocky Mountain Regional VA Medical Center.

Adequate representation in clinical trials is important to ensure therapies work the same in various populations, said Robert Dellavalle, MD, PhD, MSPH, professor, Department of Dermatology, Department of Epidemiology, University of Colorado School of Medicine, and chief of Dermatology, Rocky Mountain Regional VA Medical Center. However, a review of recent trials for hidradenitis suppurativa found certain populations were underrepresented.

In a poster1 presented at the American Academy of Dermatology annual meeting, Dellavalle and colleagues searched PubMed and ClinicalTrials.gov for phase 2 and 3 trials for hidradenitis suppurativa to gain an understanding of the current state of clinical trials for the disease in 2022. Of the 59 trials included in the analysis, 34 had monoclonal antibodies as the primary intervention. Of the studies that included race/ethnicity information, 82.86% of patients with data were White, which indicated non-White patients with hidradenitis suppurativa were underrepresented in the studies in 2022.

Dellavalle spoke with The American Journal of Managed Care® (AJMC®) about the results of the poster and the importance of diversity in clinical trials.

AJMC: A poster you presented at the annual meeting of the American Academy of Dermatology found Black patients have the highest prevalence of HS but are disproportionately underrepresented in trials. What implications does this have for treatment decisions in the real world?

Dellavalle: How different is the response in different groups to medications? How generalizable are the clinical trials? Until we have representative populations in the clinical trials we do, it will be hard to say that the drugs work as well in all of the different populations as they do in one particular population. I think that's the goal in dermatology—to bring more diversity to our patient population and clinical trials. To do that, we're going to have to build trust as a medical enterprise with people that have not been well served in the past that have rightful suspicions with the medical enterprise. Acknowledging that problem is the first step.

AJMC: What are the benefits of using biologic treatments to treat hidradenitis suppurativa over nonbiologic treatments and vice versa?

Dellavalle: Hidradenitis suppurative is a terrible disease; I would not wish on anybody to have festering sores in your private areas and underarms that really inhibit your quality of life. And we just do not have any treatments that adequately address this problem. And it's wonderful to have a new treatment like biologics that can be used to improve the quality of life of some of those patients. It's not a magic bullet, but it is an addition to the armamentarium that we can use for this terrible disease.


Mulligan KM, O’Connell KA, Kim L, et al. Demographic and therapeutic trends in clinical trials for hidradenitis suppurativa. Presented at: 2023 American Academy of Dermatology annual meeting; March 17-21, 2023; New Orleans, LA. Poster 42824.

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