Challenges in Designing Clinical Trials to Test New Drugs in the Pregnant and Breastfeeding Woman.

Until recently, pregnant or lactating women were systematically excluded from drug development. Currently, the ethical consensus is that women who are pregnant or lactating need to be involved in drug development. The rich experience of drug development in HIV/AIDS can be generalized. This article reviews contemporary, integrated, multidisciplinary best practice in the design and conduct of clinical trials that recruit women who are pregnant or lactating and shows how contemporary preclinical methods facilitate clinical studies while minimizing the use of nonhuman animal species. Community engagement is essential for drug development particularly with the rise of multiple sources of misinformation.