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

The need for new drugs in pregnancy is widely recognized. This review identifies several unique challenges and describes some solutions. Specific studies and drug development programs need careful planning that accounts for the needs of regulatory agencies. The perinatal (obstetric/pediatric) community needs to establish collaborations to develop methodologies, to facilitate data sharing, and to lobby for research and access to medicines. There is a need to gather and present information that promotes proportionate judgments of the balance between potential benefits and risks. This will require researchers to look beyond their traditional ways of working.