Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America

Abstract The lack of diversity in clinical studies has significant ethical and health consequences, limiting the development of effective treatments for diverse populations. Homogeneous participation in clinical studies contributes to health disparities, particularly among historically underrepresen...

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Main Authors: Samuel Byiringiro, Juliana K. Garcia, Nsenga Farrell, Bunmi Ogungbe, Rifath Ara Alam Barsha, Hailey N. Miller, Evans Whitaker, Paul Wang, William E. Rosa, Barbara E. Bierer, Cheryl R. Himmelfarb, Erin D. Michos, Koen De Lombaert, Maya Berdichesky, Stephan Busque, Latha Palaniappan, Eldrin Lewis, Fatima Rodriguez, Hannah Valantine
Format: Article
Language:English
Published: BMC 2025-04-01
Series:Trials
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Online Access:https://doi.org/10.1186/s13063-025-08820-y
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author Samuel Byiringiro
Juliana K. Garcia
Nsenga Farrell
Bunmi Ogungbe
Rifath Ara Alam Barsha
Hailey N. Miller
Evans Whitaker
Paul Wang
William E. Rosa
Barbara E. Bierer
Cheryl R. Himmelfarb
Erin D. Michos
Koen De Lombaert
Maya Berdichesky
Stephan Busque
Latha Palaniappan
Eldrin Lewis
Fatima Rodriguez
Hannah Valantine
author_facet Samuel Byiringiro
Juliana K. Garcia
Nsenga Farrell
Bunmi Ogungbe
Rifath Ara Alam Barsha
Hailey N. Miller
Evans Whitaker
Paul Wang
William E. Rosa
Barbara E. Bierer
Cheryl R. Himmelfarb
Erin D. Michos
Koen De Lombaert
Maya Berdichesky
Stephan Busque
Latha Palaniappan
Eldrin Lewis
Fatima Rodriguez
Hannah Valantine
author_sort Samuel Byiringiro
collection DOAJ
description Abstract The lack of diversity in clinical studies has significant ethical and health consequences, limiting the development of effective treatments for diverse populations. Homogeneous participation in clinical studies contributes to health disparities, particularly among historically underrepresented groups in the United States (US). Racial, ethnic, and other minoritized populations have long been excluded from clinical research. In response, the US Congress mandated the National Institutes of Health to assess the impacts of insufficient diversity in clinical studies. Despite efforts by the government, non-profit organizations, and industry players to improve diversity in clinical studies, progress has been slow due to fragmented approaches. For instance, the new US administration (2025) has recently released executive orders which threaten to reverse the progress made in inclusive clinical research. The Stanford Think Tank on Diversity and Equity in Clinical Trials, held in September 2023, brought together key partners across multiple sectors and professions to discuss barriers and explore potential solutions to participation in clinical studies. In this commentary, we discuss the importance of collaborative, inclusive strategies in clinical study design to advance equitable health outcomes for all. Further, we discuss potential implications of the government’s dismissal of diversity, equity, and inclusion initiatives on diverse research participation.
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spelling doaj-art-b1afa14792e54be2aa39090a6939e8232025-08-20T02:25:41ZengBMCTrials1745-62152025-04-0126111210.1186/s13063-025-08820-yAdvocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of AmericaSamuel Byiringiro0Juliana K. Garcia1Nsenga Farrell2Bunmi Ogungbe3Rifath Ara Alam Barsha4Hailey N. Miller5Evans Whitaker6Paul Wang7William E. Rosa8Barbara E. Bierer9Cheryl R. Himmelfarb10Erin D. Michos11Koen De Lombaert12Maya Berdichesky13Stephan Busque14Latha Palaniappan15Eldrin Lewis16Fatima Rodriguez17Hannah Valantine18School of Nursing, Johns Hopkins UniversityElson S Floyd College of Medicine, Washington State UniversityUniversity of PennsylvaniaSchool of Nursing, Johns Hopkins UniversitySchool of Medicine, Johns Hopkins UniversitySchool of Nursing, Johns Hopkins UniversityLane Medical Library, Stanford UniversitySchool of Medicine, Stanford UniversityDepartment of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer CenterMulti-Regional Clinical Trials Center of Brigham and Women’S Hospital and HarvardSchool of Nursing, Johns Hopkins UniversitySchool of Medicine, Johns Hopkins UniversityStudypagesSchool of Medicine, Stanford UniversitySchool of Medicine, Stanford UniversitySchool of Medicine, Stanford UniversitySchool of Medicine, Stanford UniversitySchool of Medicine, Stanford UniversitySchool of Medicine, Stanford UniversityAbstract The lack of diversity in clinical studies has significant ethical and health consequences, limiting the development of effective treatments for diverse populations. Homogeneous participation in clinical studies contributes to health disparities, particularly among historically underrepresented groups in the United States (US). Racial, ethnic, and other minoritized populations have long been excluded from clinical research. In response, the US Congress mandated the National Institutes of Health to assess the impacts of insufficient diversity in clinical studies. Despite efforts by the government, non-profit organizations, and industry players to improve diversity in clinical studies, progress has been slow due to fragmented approaches. For instance, the new US administration (2025) has recently released executive orders which threaten to reverse the progress made in inclusive clinical research. The Stanford Think Tank on Diversity and Equity in Clinical Trials, held in September 2023, brought together key partners across multiple sectors and professions to discuss barriers and explore potential solutions to participation in clinical studies. In this commentary, we discuss the importance of collaborative, inclusive strategies in clinical study design to advance equitable health outcomes for all. Further, we discuss potential implications of the government’s dismissal of diversity, equity, and inclusion initiatives on diverse research participation.https://doi.org/10.1186/s13063-025-08820-yClinical researchClinical trialsClinical studiesRegulatory institutionsDiversity in clinical research
spellingShingle Samuel Byiringiro
Juliana K. Garcia
Nsenga Farrell
Bunmi Ogungbe
Rifath Ara Alam Barsha
Hailey N. Miller
Evans Whitaker
Paul Wang
William E. Rosa
Barbara E. Bierer
Cheryl R. Himmelfarb
Erin D. Michos
Koen De Lombaert
Maya Berdichesky
Stephan Busque
Latha Palaniappan
Eldrin Lewis
Fatima Rodriguez
Hannah Valantine
Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America
Trials
Clinical research
Clinical trials
Clinical studies
Regulatory institutions
Diversity in clinical research
title Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America
title_full Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America
title_fullStr Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America
title_full_unstemmed Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America
title_short Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America
title_sort advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the united states of america
topic Clinical research
Clinical trials
Clinical studies
Regulatory institutions
Diversity in clinical research
url https://doi.org/10.1186/s13063-025-08820-y
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