Divisions of Clinical Pharmacology & Infectious Diseases, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Division of Infectious Diseases, Department of Medicine, Greater Baltimore Medical Center, Baltimore, MD, USA.
Br J Clin Pharmacol. 2022 Jan;88(1):7-21. doi: 10.1111/bcp.14914. Epub 2021 May 30.
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 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 foetus. 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, and the ethical and legal frameworks that inform the conduct of such research, then highlights examples of innovative practice that have enabled high quality, ethical research to proceed to inform the evidence-based use of medication in pregnancy.
孕妇或可能怀孕的女性历来被排除在新药临床试验之外。然而，人们越来越认识到，必须从可能使用这些药物的人群中获得证据，以告知安全、基于证据的共同临床决策。研究人员和监管机构不愿进行此类研究通常与对风险的担忧有关，特别是对胎儿的担忧。然而，这必须与未治疗疾病的风险或在怀孕期间使用安全性、疗效和剂量信息未知的药物相平衡。这篇综述总结了历史观点，以及指导此类研究的伦理和法律框架，然后强调了一些创新实践的例子，这些实践使高质量、符合伦理的研究得以进行，为基于证据的孕期用药提供信息。
