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Ethical issues in therapeutic use and research in pregnant and breastfeeding women
  • Ethel Weld,
  • Theodore Bailey,
  • Catrionia Waitt
Ethel Weld
Johns Hopkins University School of Medicine
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Theodore Bailey
Greater Baltimore Medical Center
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Catrionia Waitt
University of Liverpool
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Abstract

Pregnant, or potentially pregnant women have historically been excluded from clinical trials of new medications. However, it is increasingly recognised that it is imperative to generate evidence from the population in whom the drugs are likely to be used in order to inform safe, evidence-based shared clinical decision making. Reluctance by researchers and regulators to perform such studies often relates to concerns about risk, particularly to the fetus. However, this must be offset against the risk of untreated disease or using a drug in pregnancy where safety, efficacy and dosing information are not known. This review summarises the historical perspective, the ethical and legal frameworks which inform the conduct of such research, then highlights examples of innovative practice which have enabled high quality, ethical research to proceed to inform the evidence-based use of medication in pregnancy.

Peer review status:ACCEPTED

15 Mar 2021Submitted to British Journal of Clinical Pharmacology
16 Mar 2021Submission Checks Completed
16 Mar 2021Assigned to Editor
25 Mar 2021Reviewer(s) Assigned
20 Apr 2021Review(s) Completed, Editorial Evaluation Pending
21 Apr 2021Editorial Decision: Revise Minor
28 Apr 20211st Revision Received
29 Apr 2021Submission Checks Completed
29 Apr 2021Assigned to Editor
29 Apr 2021Review(s) Completed, Editorial Evaluation Pending
10 May 2021Editorial Decision: Accept