Ethical issues in therapeutic use and research in pregnant and
breastfeeding women
- Ethel Weld
, - Theodore Bailey,
- Catrionia Waitt
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.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
Jan 2022Published in British Journal of Clinical Pharmacology volume 88 issue 1 on pages 7-21. 10.1111/bcp.14914