Why Diversity in Dermatology Clinical Trials Should No Longer Be Optional

Abstract

While race and ethnicity reporting in dermatology clinical trials has slightly improved in the last 5 years, 1,2 the proportion of studies with adequate racial and ethnic diversity remains unchanged. Despite National Institutes of Health (NIH) diversity mandates 3 and 2020 Food and Drug Administration (FDA) guidelines, 4 dermatology continues to underreport race and ethnicity demographic data in clinical trials.Why is diversity in clinical trials a critical aim for dermatology as a specialty? Reporting race and ethnicity in clinical trial publications signifies its value and importance. Ensuring diversity among clinical trial participants should no longer be optional, as it accomplishes several important aims: it increases generalizability of the trial results, ensures safety and clinical benefit for diverse populations, and imparts fairness and equity. 5 A diverse study population helps to ensure that all members of society, regardless of race, ethnicity, gender identity, age, sex, or socioeconomic status, have access to new therapies and to incur the benefits and risks of a trial intervention equally. This includes both the potential benefits of high-quality tertiary care, new advanced therapies, and access to subspecialty physicians, as well as the potential risks of adverse effects of novel agents or interventions. Lack of equitable participation in clinical trials is a manifestation of systemic racism. If the dermatologic research community prioritizes addressing the systemic racism that results in the lack of equitable participation in clinical trials, previously marginalized patients move one step closer toward improved health outcomes and justice.Why does a lack of diversity in dermatologic clinical trials exist? Dermatology's troubled relationship with racism in clinical research may serve as part of the underpinnings of the mistrust of institutionalized medicine by racial and ethnic minority communities. For example, the ethical abuses of the Tuskegee syphilis study are widely known-Black study participants were prevented from accessing syphilis treatment even as they were incurring permanent morbidity, including, but not limited to, dermatologic gummas, tissue destruction, and death from an otherwise treatable illness. But few may know of the experiments conducted at Holmesburg Prison in Philadelphia , led by dermatologist Albert Kligman, MD. 5,6 For 23 years, Kligman performed clinical trials using mostly incarcerated Black men to test the efficacy and safety of several dermatological treatments with funding from both pharmaceutical companies and government agencies. The most notable drug developed from these experiments is the widely used acne medication tretinoin. In the Holmesburg Prison experiments, research participants were subjected to significant harms of participation in clinical trials by way of exploitation, lack of informed consent, and coercion. These experiments highlight a disregard for margin-Opinion EDITORIAL jamadermatology.com (Reprinted)

Objective response to immune checkpoint inhibitor therapy in NRAS-mutant melanoma: A systematic review and meta-analysis

“…It is well known that non-cutaneous melanoma subtypes carry unique mutation patterns distinct from ultraviolet radiation-related signatures and often respond poorly to current therapies ( 43 – 45 ). Further investigation of this diverse population is warranted to better guide therapy and improve outcomes ( 46 , 47 ).…”

Why Increased Diversity in Dermatologic Clinical Trials Is Not Inherently Ethical—An Evidence-Based, Community-Engaged Approach to Diverse Trial Recruitment

“…To the Editor Kamal et al aptly name the historical and contemporary factors that shape limited ethnoracial diversity in dermatologic clinical trials and articulate the urgency of leveraging community relationships for trial diversification. We agree with the promise of partnering with influential community members to address the lack of diversity in clinical trials .…”

“…To the Editor Kamal et al aptly name the historical and contemporary factors that shape limited ethnoracial diversity in dermatologic clinical trials and articulate the urgency of leveraging community relationships for trial diversification. We agree with the promise of partnering with influential community members to address the lack of diversity in clinical trials . However, for historically marginalized populations, limited trial participation is a natural consequence of and an adaptive response to a health care system that has not adequately met their needs .…”

“…Second, to increase community buy-in, dermatologists committed to diversifying clinical trials should apply cultural humility and prioritize continuous shared decision-making . Kamal et al articulate the importance of cultural competency. Cultural humility contrasts cultural competency in that it emphasizes curiosity and respect vs the elusive goal of competence in another’s culture .…”

“…The final community engagement principle within this framework is representation. Kamal et al note the importance of increasing workforce diversity in dermatology to demonstrate meaningful institutional commitment to antiracism. However, we posit that increasing workforce diversity has benefits beyond restorative justice.…”