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2 results on '"inclusion of pregnant women in trials"'

1. Pregnant Women in Trials of Covid‐19: A Critical Time to Consider Ethical Frameworks of Inclusion in Clinical Trials.

Author

Farrell, Ruth, Michie, Marsha, and Pope, Rachel

Subjects
*PREGNANT women, *CLINICAL trials, *DECISION making, *COVID-19 pandemic, *PREGNANCY
Abstract

Ethical issues abound during this unprecedented international public health crisis of Covid‐19. While the trade‐off between societal and individual interests that occurs at the intersection of public health ethics and clinical ethics affects all populations, this calculus has particular relevance for pregnant women and the question of when they will have access to new Covid‐19 therapies and vaccines. Pregnant women are a "scientifically complex" population whose inclusion in clinical research must be done with consideration of the unique state of pregnancy. Yet research on the impact of Covid‐19 on pregnant women is lagging. In a rush to prevent and treat SARS‐CoV‐2 infection, it is crucial that the interests of pregnant women be prioritized to enable them to make autonomous, informed decisions about participating in clinical trials. The global pandemic calls for a revisiting of frameworks for the inclusion of pregnant women in research, as these women have an important stake in the prevention and treatment of Covid‐19. [ABSTRACT FROM AUTHOR]

Published
2020
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2. Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change

Author

Emily G. McDonald, Haim A. Abenhaim, Stephen E. Lapinsky, Matthew P. Cheng, Isabelle Malhamé, Annabelle Cumyn, Marie-Julie Trahan, and Nick Daneman

Subjects
medicine.medical_specialty, Canada, Health (social science), Coronavirus disease 2019 (COVID-19), Computer-assisted web interviewing, Article, research with pregnant women, Pregnancy, inclusion of pregnant women in trials, Physicians, Medicine, Humans, pregnant research participants, reproductive and urinary physiology, business.industry, SARS-CoV-2, COVID-19, Covid‐19 clinical trials, Articles, medicine.disease, Clinical trial, Clinical research, Paradigm shift, Family medicine, maternal‐fetal ethics, Female, Pregnant Women, human subjects research, business, Inclusion (education)
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.

Published
2021

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