(237) The Representation of Minority Men in a Restorative Therapy Clinical Trial for Erectile Dysfunction
Authors: Ghomeshi A , Ledesma B , Thomas J , Saltzman R , Arbelaez MCS , Almatari A , White J , Ramasamy R 
Published: February 2024

Abstract

Introduction
Prior studies have shown underrepresentation of minority men in clinical trials. The NIH has issued a mandate to include minority groups in clinical trials, however, there is still significant underrepresentation in urological trials. Therapeutic interventions for erectile dysfunction (ED) have also demonstrated different patterns across various ethnic groups, even after accounting for socio-economic factors. To attain an appropriate level of external validity, which is essential for the accurate generalization of research findings to the broader population, it is of paramount importance to include underrepresented minorities in clinical trials involving treatment modalities for ED.

Objective
We present a retrospective descriptive analysis to evaluate the demographic composition of our recently completed clinical trial: A Randomized, Double-Blind, Placebo Controlled Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma (PRP) for Treatment of Erectile Dysfunction to improve our understanding of this treatment modality’s therapeutic efficacy for different ethnic minority groups.

Methods
Demographic data was collected from all participants and the prevalence in our population was compared to the source population. The proportion of individuals who participated in our study from each demographic category was then compared to the proportion of those in both the local and nationwide populations. A PPR value between 0.8 and 1.2 demonstrates adequate representation. A value &lt;0.8 indicates underrepresentation and a value &gt;1.2 denotes overrepresentation.

Results
Among the 61 participants enrolled in the PRP trial, 72.1% were Hispanic compared to 39.9% in the national source population. There were 27.9% non-Hispanic participants, and 41.2% non-Hispanic men in the local South Florida population. The racial composition of our study shows 80.3% of PRP participants identify as White, 16.4% as Black, and 3.4% as Asian. In the national source population, 61.8% of patients were White, 27.5% are black, and 1.5% are Asian. PPR analyses of our cohort showed an over-representation of Hispanic men compared to both the national and local levels, with PPR values of 1.81 and 1.27, respectively. Similarly, an overrepresentation of Asian men was observed both locally as well as nationwide, with PPR values of 2.11 and 2.16, respectively (Figure 1). Of note, our study had a lower participation of African-American patients (PPR 0.60) compared to national registries, but high representation (PPR 1.30), compared to local demographics. There also was an accurate representation of white men from the South Florida population in our clinical trial, reporting a PPR value of 0.98.

Conclusions
Through the implementation of strategies such as having Hispanic team members on the clinical trial staff and providing education and outreach materials both in Spanish and English, we were able to overcome barriers to participation in Hispanic men and potentially improve health outcomes for underrepresented minority men with ED. We encourage other research institutions to adopt similar practices to promote the accurate representation of all communities in medical research.

Disclosure
Yes, this is sponsored by industry/sponsor: NIH Grant R01 DK130991.
Clarification: Industry funding only - investigator initiated and executed study.