医生对将孕妇纳入新冠肺炎临床试验的看法:是时候改变范式了。

Q2 Social Sciences
Marie-Julie Trahan, Annabelle Cumyn, Matthew P. Cheng, Emily G. McDonald, Stephen E. Lapinsky, Nick Daneman, Haim A. Abenhaim, Isabelle Malhamé
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引用次数: 2

摘要

将孕妇排除在新冠肺炎临床试验之外可能会导致意想不到的有害后果。在这项研究中,向加拿大专业医学协会的医生发送了一份在线问卷,以评估他们对孕妇参与新冠肺炎临床试验的看法。大多数受访者表示支持将孕妇纳入新冠肺炎试验(119/165;72%),尤其是那些调查有妊娠期安全记录的疗法的人(139/164;85%)。发现的纳入的主要障碍是孕妇不愿参与,治疗团队不愿参与,监管审批的负担,以及孕妇被排除在试验之外的普遍“文化”。我们描述了为什么一些医生可能不愿意将孕妇纳入试验,并确定了孕妇适当参与临床研究的障碍。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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

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.

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来源期刊
Ethics & human research
Ethics & human research Social Sciences-Health (social science)
CiteScore
2.90
自引率
0.00%
发文量
35
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