Saltzman Russell G, Zucker Isaac, Campbell Katherine, Gandhi Deep A, Otiono Kikachukwu, Weber Alexander, Masterson Thomas A, Ramasamy Ranjith
Miller School of Medicine, University of Miami, Miami, FL, USA.
Herbert Wertheim School of Medicine, Florida International University, Miami, FL, USA.
Contemp Clin Trials Commun. 2022 Aug 28;29:100986. doi: 10.1016/j.conctc.2022.100986. eCollection 2022 Oct.
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. Our objective is to analyze the inclusion of minority men in clinical trials for erectile dysfunction (ED).
We searched ClinicalTrials.gov for the disease keyword: "Erectile Dysfunction" and used "Prostate Cancer" for comparison. Completed trials which reported demographic data were included for analysis. Literature was reviewed to determine the prevalence of ED and prostate cancer (PC) 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 and 1.2 indicates adequate representation, <0.8 is under-representation and >1.2 is over-representation.
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 4.6% 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 comprise 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 = 0.64; AA PC PPR = 0.58).
Our analysis shows that both Hispanic and AA men are underrepresented in both ED and PC clinical trials.
将少数族裔纳入临床试验对于全面评估治疗效果至关重要。众所周知，不同人群对干预措施的反应存在差异。我们的目标是分析少数族裔男性在勃起功能障碍（ED）临床试验中的纳入情况。
我们在ClinicalTrials.gov上搜索疾病关键词“勃起功能障碍”，并使用“前列腺癌”作为对照。纳入报告了人口统计学数据的已完成试验进行分析。查阅文献以确定西班牙裔、黑人、白人和亚洲男性中ED和前列腺癌（PC）的患病率。将每组参与试验的个体比例除以该组在疾病人群中的比例，以计算“参与率与患病率之比”（PPR）。PPR在0.8至1.2之间表示代表性充足，<0.8表示代表性不足，>1.2表示代表性过度。
共评估了312项试验：289项针对前列腺癌，23项针对ED。西班牙裔男性占ED试验参与者的11.8%，占前列腺癌试验参与者的4.6%，但占ED患者的18%，占PC患者的7.3%。黑人/非裔美国（AA）男性占ED试验参与者的10.2%，占PC试验参与者的9.4%，但占ED患者的16%，占PC患者的16.3%。西班牙裔和AA男性在ED和前列腺癌试验中的代表性不足（西班牙裔ED PPR = 0.66；西班牙裔PC PPR = 0.63；AA ED PPR = 0.64；AA PC PPR = 0.58）。
我们的分析表明，西班牙裔和AA男性在ED和PC临床试验中的代表性均不足。
