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Research involving pregnant women: trials and tribulations

Francoise Baylis, Scott A. Halperin

Pregnant women and their fetuses deserve timely access to safe, effective, evidence-based care. To this end, pregnant women should be included in clinical trials of drugs and vaccines, except when there is a compelling scientific or ethical reason not to do so. This article examines the benefits and limitations of two different starting points for research involving pregnant women. The first option would have stand-alone Phase I trials for pregnant women initiated at the same time as Phase III trials in the general population. The second option would have Phase I trials for pregnant women embedded into late Phase II or Phase III trials, with enhanced monitoring for pregnant women, similar to that done in a stand-alone Phase I trial.