Redefining standards: Improving community-reflective practices in dermatology clinical trials

IMPORTANCE: Clinical trial participation in the United States remains disproportionately low among underrepresented racial, ethnic, and gender-diverse populations, limiting the generalizability of research findings and the development of treatments that address all patients' needs. Dermatology, where skin type, pigmentation, and cultural practices directly influence disease presentation and treatment response, exemplifies these challenges. This communication examines historical and contemporary efforts to improve inclusivity in clinical research, highlights barriers to equitable participation, and evaluates the role of federal regulations and patient-centered outcomes in promoting representative clinical trials. OBSERVATIONS: Evidence indicates persistent underrepresentation of Black, Hispanic, American Indian, Pacific Islander, and transgender populations in clinical trials despite longstanding federal mandates, including NIH inclusion policies and FDA diversity reporting initiatives. While inclusion of women has improved, racial and gender-diverse representation remains low. Barriers to participation include historical mistrust stemming from unethical research practices, insufficient community engagement, limited diversity among investigators, and underreporting of outcomes relevant to underrepresented populations, such as post-inflammatory hyperpigmentation in dermatology. Federal efforts, such as demographic reporting and diversity action plans, have improved transparency but show uneven progress. Emerging policies and executive orders have the potential to influence progress in diversity and equity. Studies suggest that community partnerships, diverse investigator teams, incorporation of specialty-specific metrics, and patient-centered outcomes can enhance recruitment, improve trial relevance, and rebuild trust among marginalized populations. CONCLUSIONS AND RELEVANCE: Clinical trial inclusivity remains a critical challenge, particularly in dermatology, where diverse patient representation directly impacts treatment applicability. Ensuring equitable participation requires coordinated strategies, including federal oversight, community engagement, and investigator diversity, along with inclusion of patient-centered and dermatology-specific outcomes. Implementing these measures can improve the generalizability of findings, guide evidence-based treatment for all populations, and promote health equity in clinical care.