(314) An Evaluation of Race-Based Representation Among Men Participating in Clinical Trials for Prostate Cancer and Erectile Dysfunction

Abstract

Abstract Introduction Inclusion of ethnic/racial minorities in clinical trials is essential to fully assess therapeutic efficacy. It is well-known that populations respond dissimilarly to interventions. This concept has been research ed thoroughly in the context of urologic oncology research, however research into the impact of demographic characteristics in andrology trials is lacking. Objective To analyze the inclusion of historically under-represented minority men in clinical trials for Erectile Dysfunction (ED) in comparison to Prostate Cancer (PC) trials. Methods We searched ClinicalTrials.gov for the disease keyword: “Erectile Dysfunction” and used “Prostate Cancer” trials for comparison. Completed trials that had available demographic data were included for analysis. Literature was reviewed to determine the prevalence of ED and PC diagnosed among Hispanic, Black, White, and Asian men. The proportion of individuals of each group that participated in trials is divided by the proportion of each group in the disease population to calculate the “Participation to Prevalence Ratio” (PPR). PPRs between 0.8-1.2 indicates adequate representation, 1.2 is over-representation. Results A total of 312 trials were assessed: 289 for prostate cancer and 23 for ED. Hispanic men comprised 11.8% of ED trial participants and 4.61% of prostate cancer trial participants, yet represented 18% of ED patients and 7.3% of PC patients. Black/African-American (AA) men accounted for 10.2% of ED trial participants and 9.4% of PC trial participants, but comprised 16% of ED patients, and 16.3% of PC patients. Hispanic and AA men are under-represented in trials for ED and Prostate Cancer (Hispanic ED PPR=0.66; Hispanic PC PPR=0.63; AA ED PPR=0.42; AA PC PPR=0.58). Conclusions Our findings show that both Hispanic and AA men are underrepresented in both ED and PC clinical trials. A greater emphasis must be placed on achieving representative enrollment in clinical trials for ED and PC in order to address this disparity and improve generalizability of the findings. Disclosure No