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An evaluation of race-based representation among men participating in clinical trials for prostate cancer and erectile dysfunction

BACKGROUND: 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)....

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Autores principales: Saltzman, Russell G., Zucker, Isaac, Campbell, Katherine, Gandhi, Deep A., Otiono, Kikachukwu, Weber, Alexander, Masterson, Thomas A., Ramasamy, Ranjith
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9450121/
https://www.ncbi.nlm.nih.gov/pubmed/36092973
http://dx.doi.org/10.1016/j.conctc.2022.100986
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author Saltzman, Russell G.
Zucker, Isaac
Campbell, Katherine
Gandhi, Deep A.
Otiono, Kikachukwu
Weber, Alexander
Masterson, Thomas A.
Ramasamy, Ranjith
author_facet Saltzman, Russell G.
Zucker, Isaac
Campbell, Katherine
Gandhi, Deep A.
Otiono, Kikachukwu
Weber, Alexander
Masterson, Thomas A.
Ramasamy, Ranjith
author_sort Saltzman, Russell G.
collection PubMed
description BACKGROUND: 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). METHODS: 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. 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 4.6% 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). CONCLUSION: Our analysis shows that both Hispanic and AA men are underrepresented in both ED and PC clinical trials.
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spelling pubmed-94501212022-09-08 An evaluation of race-based representation among men participating in clinical trials for prostate cancer and erectile dysfunction Saltzman, Russell G. Zucker, Isaac Campbell, Katherine Gandhi, Deep A. Otiono, Kikachukwu Weber, Alexander Masterson, Thomas A. Ramasamy, Ranjith Contemp Clin Trials Commun Article BACKGROUND: 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). METHODS: 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. 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 4.6% 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). CONCLUSION: Our analysis shows that both Hispanic and AA men are underrepresented in both ED and PC clinical trials. Elsevier 2022-08-28 /pmc/articles/PMC9450121/ /pubmed/36092973 http://dx.doi.org/10.1016/j.conctc.2022.100986 Text en © 2022 Published by Elsevier Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Saltzman, Russell G.
Zucker, Isaac
Campbell, Katherine
Gandhi, Deep A.
Otiono, Kikachukwu
Weber, Alexander
Masterson, Thomas A.
Ramasamy, Ranjith
An evaluation of race-based representation among men participating in clinical trials for prostate cancer and erectile dysfunction
title An evaluation of race-based representation among men participating in clinical trials for prostate cancer and erectile dysfunction
title_full An evaluation of race-based representation among men participating in clinical trials for prostate cancer and erectile dysfunction
title_fullStr An evaluation of race-based representation among men participating in clinical trials for prostate cancer and erectile dysfunction
title_full_unstemmed An evaluation of race-based representation among men participating in clinical trials for prostate cancer and erectile dysfunction
title_short An evaluation of race-based representation among men participating in clinical trials for prostate cancer and erectile dysfunction
title_sort evaluation of race-based representation among men participating in clinical trials for prostate cancer and erectile dysfunction
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9450121/
https://www.ncbi.nlm.nih.gov/pubmed/36092973
http://dx.doi.org/10.1016/j.conctc.2022.100986
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