Journal article
Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review
M Shankar, A Hazfiarini, RI Zahroh, JP Vogel, ARA McDougall, P Condron, SS Goudar, YV Pujar, MS Somannavar, U Charantimath, A Ammerdorffer, S Rushwan, AM Gülmezoglu, MA Bohren
Plos Medicine | PUBLIC LIBRARY SCIENCE | Published : 2024
Open access
Abstract
Background AU Poor: Pleaseconfirmthatallheadinglevelsarerepresentedcorrectly representation of pregnant and lactating women and people : in clinical trials has marginalised their health concerns and denied the maternal–fetal/infant dyad benefits of innovation in therapeutic research and development. This mixed-methods systematic review synthesised factors affecting the participation of pregnant and lactating women in clinical trials, across all levels of the research ecosystem. Methods and findings We searched 8 databases from inception to 14 February 2024 to identify qualitative, quantitative, and mixed-methods studies that described factors affecting participation of pregnant and lactating..
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Awarded by Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Funding Acknowledgements
The research in this publication was supported by funding from MSD (grant MFM-22-159697 to Concept Foundation), through its MSD for Mothers initiative (https://www.msdformothers.com/) and is the sole responsibility of the authors. MSD for Mothers is an initiative of Merck & Co., Inc., Rahway, NJ, U.S.A. MAB's time is supported by an Australian Research Council Discovery Early Career Researcher Award (DE200100264) and a Dame Kate Campbell Fellowship (University of Melbourne Faculty of Medicine, Dentistry and Health Sciences). JPV is supported by an Australian National Health and Medical Research Council (NHMRC) Investigator grant (GNT1194248). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.