Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people

Abstract Systematic under-representation of pregnant women and gender diverse pregnant people in clinical research has prevented them from benefitting fairly from biomedical advances. The resulting lack of pharmacological safety and efficacy data leads to medicine discontinuation, sub-optimal dosing...

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Main Authors: Mridula Shankar, A. Metin Gülmezoglu, Joshua P. Vogel, Shivaprasad S. Goudar, Annie McDougall, Manjunath S. Somannavar, Sara Rushwan, Yeshita V. Pujar, Umesh Charantimath, Anne Ammerdorffer, Meghan A. Bohren
Format: Article
Language:English
Published: Nature Portfolio 2024-10-01
Series:Communications Medicine
Online Access:https://doi.org/10.1038/s43856-024-00629-1
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author Mridula Shankar
A. Metin Gülmezoglu
Joshua P. Vogel
Shivaprasad S. Goudar
Annie McDougall
Manjunath S. Somannavar
Sara Rushwan
Yeshita V. Pujar
Umesh Charantimath
Anne Ammerdorffer
Meghan A. Bohren
author_facet Mridula Shankar
A. Metin Gülmezoglu
Joshua P. Vogel
Shivaprasad S. Goudar
Annie McDougall
Manjunath S. Somannavar
Sara Rushwan
Yeshita V. Pujar
Umesh Charantimath
Anne Ammerdorffer
Meghan A. Bohren
author_sort Mridula Shankar
collection DOAJ
description Abstract Systematic under-representation of pregnant women and gender diverse pregnant people in clinical research has prevented them from benefitting fairly from biomedical advances. The resulting lack of pharmacological safety and efficacy data leads to medicine discontinuation, sub-optimal dosing, and reliance on repurposed therapies. We identify four roadblocks to fair inclusion. First, investment and research are inhibited by protectionist attitudes among research gatekeepers who view pregnancy as a vulnerable state. Second, exclusion ignores human-specific biological variations affecting medication absorption and impacts on the pregnant body. Third, pregnant populations in low-and middle-income countries face a double disadvantage due to gender and location, despite bearing a disproportionate maternal mortality burden. Fourth, perspectives and experiences of pregnant populations are undervalued in clinical intervention design. We propose five actions to optimize fair inclusion: fostering reciprocal partnerships, prioritizing multi-disciplinary research, awareness-raising of the need for pharmaceutical innovation, conducting regulatory analyses, and promoting responsible inclusion over presumptive exclusion.
format Article
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institution Kabale University
issn 2730-664X
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publishDate 2024-10-01
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spelling doaj-art-0709eee9687c4b6d8c91e66b8de4e74c2024-12-08T12:44:25ZengNature PortfolioCommunications Medicine2730-664X2024-10-01411510.1038/s43856-024-00629-1Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse peopleMridula Shankar0A. Metin Gülmezoglu1Joshua P. Vogel2Shivaprasad S. Goudar3Annie McDougall4Manjunath S. Somannavar5Sara Rushwan6Yeshita V. Pujar7Umesh Charantimath8Anne Ammerdorffer9Meghan A. Bohren10Gender and Women’s Health Unit, Nossal Institute for Global Health, School of Population and Global Health, The University of MelbourneConcept FoundationWomen’s, Children’s and Adolescents’ Health Program, Burnet InstituteWomen’s and Children’s Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical CollegeWomen’s, Children’s and Adolescents’ Health Program, Burnet InstituteWomen’s and Children’s Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical CollegeConcept FoundationWomen’s and Children’s Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical CollegeWomen’s and Children’s Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical CollegeConcept FoundationGender and Women’s Health Unit, Nossal Institute for Global Health, School of Population and Global Health, The University of MelbourneAbstract Systematic under-representation of pregnant women and gender diverse pregnant people in clinical research has prevented them from benefitting fairly from biomedical advances. The resulting lack of pharmacological safety and efficacy data leads to medicine discontinuation, sub-optimal dosing, and reliance on repurposed therapies. We identify four roadblocks to fair inclusion. First, investment and research are inhibited by protectionist attitudes among research gatekeepers who view pregnancy as a vulnerable state. Second, exclusion ignores human-specific biological variations affecting medication absorption and impacts on the pregnant body. Third, pregnant populations in low-and middle-income countries face a double disadvantage due to gender and location, despite bearing a disproportionate maternal mortality burden. Fourth, perspectives and experiences of pregnant populations are undervalued in clinical intervention design. We propose five actions to optimize fair inclusion: fostering reciprocal partnerships, prioritizing multi-disciplinary research, awareness-raising of the need for pharmaceutical innovation, conducting regulatory analyses, and promoting responsible inclusion over presumptive exclusion.https://doi.org/10.1038/s43856-024-00629-1
spellingShingle Mridula Shankar
A. Metin Gülmezoglu
Joshua P. Vogel
Shivaprasad S. Goudar
Annie McDougall
Manjunath S. Somannavar
Sara Rushwan
Yeshita V. Pujar
Umesh Charantimath
Anne Ammerdorffer
Meghan A. Bohren
Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people
Communications Medicine
title Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people
title_full Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people
title_fullStr Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people
title_full_unstemmed Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people
title_short Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people
title_sort eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people
url https://doi.org/10.1038/s43856-024-00629-1
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