Diversity matters in Peyronie's disease clinical trials-a systematic review.

Abstract

Introduction: Recent studies have demonstrated a distressing lack of diversity in urology clinical trials. Diversity is important to ensure that trial outcomes accurately represent the gamut of patients with a condition. We aimed to assess the current literature landscape of ethnic and racial diversity on clinical trials for Peyronie's disease (PD).

Objective: Investigate the representation of different racial and ethnic groups in PD clinical trials.

Methods: In September 2024, a systematic review of Peyronie's disease clinical trials in the published English literature was performed using the Ovid, Embase, and Medline/PubMed databases. Articles were included if they were in English, relevant to Peyronie's disease, and specified clinical trial in the title or abstract. Articles were excluded if they included patients with congenital penile curvature, pooled analyses, abstracts with incomplete information, and/or ongoing incomplete clinical trials.

Results: The initial search yielded 494 studies. After screening, and full-text review, 75 articles met the inclusion criteria. Of the 75 articles included in this systematic review, only 10 (13.3%) reported participant race and ethnicity with a pooled population totaling 1948 men. All 10 studies reported enrollment of Caucasian men, with Caucasian men making up 95.6% of the enrolled population. Enrollment of Black men was reported in 6 of the 10 studies and constituted 4% of included patients. Enrollment of Asian men was reported in 2 (2.6%) studies and comprised 0.1% of included patients. Enrollment of American Indian/Native American men was reported in only 1 (1.4%) study and comprised 0.05% of patients. Hispanic ethnicity was the only ethnicity reported and was available in 5 (8.1%) studies with 3.8% of men reported as Hispanic.Five of the 10 studies that reported race enrolled patients exclusively from the United States.The 5 US-based studies showed a significant disparity in representation compared to the 2020 US Census (P < .001). Caucasian men were overrepresented, while all other racial and ethnic groups were underrepresented.

Conclusions: There is an over-representation of Caucasian men and an underrepresentation of other races, along with a lack of representation of racial and ethnic minorities with PD. This may lead to clinical trial outcomes being non-generalizable. Further studies with diverse populations are needed.