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Physician Perspectives on Including Pregnant Women in Covid‐19 Clinical Trials: Time for a Paradigm Change

Authors :
Trahan, Marie‐Julie
Cumyn, Annabelle
Cheng, Matthew P.
McDonald, Emily G.
Lapinsky, Stephen E.
Daneman, Nick
Abenhaim, Haim A.
Malhamé, Isabelle
Source :
Ethics & Human Research; November 2021, Vol. 43 Issue: 6 p19-27, 9p
Publication Year :
2021

Abstract

Excluding pregnant people from Covid‐19 clinical trials may lead to unintended harmful consequences. For this study, an online questionnaire was sent to physicians belonging to Canadian professional medical associations in order to evaluate their perspectives on the participation of pregnant women in Covid‐19 clinical trials. The majority of respondents expressed support for including pregnant women in Covid‐19 trials (119/165; 72%), especially those investigating therapies with a prior safety record in pregnancy (139/164; 85%). The main perceived barriers to inclusion identified were unwillingness of pregnant patients to participate and of treating teams to offer participation, the burden of regulatory approval, and a general “culture of exclusion” of pregnant women from trials. We describe why some physicians may be reluctant to include pregnant individuals in trials, and we identify barriers to the appropriate participation of pregnant people in clinical research.

Details

Language :
English
ISSN :
25782355 and 25782363
Volume :
43
Issue :
6
Database :
Supplemental Index
Journal :
Ethics & Human Research
Publication Type :
Periodical
Accession number :
ejs58219903
Full Text :
https://doi.org/10.1002/eahr.500107