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Attention for sex in COVID-19 trials: a review of regulatory dossiers

An under-representation of women and a lack of sex-specific analyses in COVID-19 trials has been suggested. However, the higher number of men than women who are severely affected by COVID-19 and the restricted information in scientific publications may have biased these suggestions. Therefore, we ev...

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Autores principales: de Vries, Sieta T, Starokozhko, Viktoriia, Schellens, Ingrid M M, Wijnans, Leonoor, Enzmann, Harald, Cavaleri, Marco, Mol, Peter G M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8935005/
https://www.ncbi.nlm.nih.gov/pubmed/35304352
http://dx.doi.org/10.1136/bmjgh-2021-008173
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author de Vries, Sieta T
Starokozhko, Viktoriia
Schellens, Ingrid M M
Wijnans, Leonoor
Enzmann, Harald
Cavaleri, Marco
Mol, Peter G M
author_facet de Vries, Sieta T
Starokozhko, Viktoriia
Schellens, Ingrid M M
Wijnans, Leonoor
Enzmann, Harald
Cavaleri, Marco
Mol, Peter G M
author_sort de Vries, Sieta T
collection PubMed
description An under-representation of women and a lack of sex-specific analyses in COVID-19 trials has been suggested. However, the higher number of men than women who are severely affected by COVID-19 and the restricted information in scientific publications may have biased these suggestions. Therefore, we evaluated sex proportionality and sex-specific efficacy and safety data in trials of COVID-19 treatments and vaccines using both publicly available regulatory documents and confidential documents used by regulators in their review of medicinal products. Included were two treatments (ie, remdesivir and dexamethasone) and four vaccines (ie, BNT162b2 mRNA (BioNTech/Pfizer), mRNA-1273 (Moderna), ChAdOx1-S (AstraZeneca) and Ad26.COV2-S (Janssen)) that received marketing authorisation by the European Commission at the time of the study conduct. An under-representation of women was shown in three of the nine data sets for one treatment (ie, remdesivir), but the proportion of women included was representative in each of the data sets for the other five products. This indicates that there is no structural under-representation of women in the COVID-19 trials. Currently, sex-specific efficacy data are available for five of the six assessed products and sex-specific safety data are available for half of the products only. It is important that this information will also be made available for the other products. There are only small differences in efficacy and safety between men and women which are likely to be of limited clinical relevance. Sex-specific efficacy information can generally be found in the publicly available regulatory documents other than the Summary of Product Characteristics, for which more awareness might be required.
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spelling pubmed-89350052022-03-22 Attention for sex in COVID-19 trials: a review of regulatory dossiers de Vries, Sieta T Starokozhko, Viktoriia Schellens, Ingrid M M Wijnans, Leonoor Enzmann, Harald Cavaleri, Marco Mol, Peter G M BMJ Glob Health Practice An under-representation of women and a lack of sex-specific analyses in COVID-19 trials has been suggested. However, the higher number of men than women who are severely affected by COVID-19 and the restricted information in scientific publications may have biased these suggestions. Therefore, we evaluated sex proportionality and sex-specific efficacy and safety data in trials of COVID-19 treatments and vaccines using both publicly available regulatory documents and confidential documents used by regulators in their review of medicinal products. Included were two treatments (ie, remdesivir and dexamethasone) and four vaccines (ie, BNT162b2 mRNA (BioNTech/Pfizer), mRNA-1273 (Moderna), ChAdOx1-S (AstraZeneca) and Ad26.COV2-S (Janssen)) that received marketing authorisation by the European Commission at the time of the study conduct. An under-representation of women was shown in three of the nine data sets for one treatment (ie, remdesivir), but the proportion of women included was representative in each of the data sets for the other five products. This indicates that there is no structural under-representation of women in the COVID-19 trials. Currently, sex-specific efficacy data are available for five of the six assessed products and sex-specific safety data are available for half of the products only. It is important that this information will also be made available for the other products. There are only small differences in efficacy and safety between men and women which are likely to be of limited clinical relevance. Sex-specific efficacy information can generally be found in the publicly available regulatory documents other than the Summary of Product Characteristics, for which more awareness might be required. BMJ Publishing Group 2022-03-18 /pmc/articles/PMC8935005/ /pubmed/35304352 http://dx.doi.org/10.1136/bmjgh-2021-008173 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Practice
de Vries, Sieta T
Starokozhko, Viktoriia
Schellens, Ingrid M M
Wijnans, Leonoor
Enzmann, Harald
Cavaleri, Marco
Mol, Peter G M
Attention for sex in COVID-19 trials: a review of regulatory dossiers
title Attention for sex in COVID-19 trials: a review of regulatory dossiers
title_full Attention for sex in COVID-19 trials: a review of regulatory dossiers
title_fullStr Attention for sex in COVID-19 trials: a review of regulatory dossiers
title_full_unstemmed Attention for sex in COVID-19 trials: a review of regulatory dossiers
title_short Attention for sex in COVID-19 trials: a review of regulatory dossiers
title_sort attention for sex in covid-19 trials: a review of regulatory dossiers
topic Practice
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8935005/
https://www.ncbi.nlm.nih.gov/pubmed/35304352
http://dx.doi.org/10.1136/bmjgh-2021-008173
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