Regarding logistics, with stand-alone Phase I trials for pregnant women there would be advantages in identifying qualified investigators to undertake the clinical trials and in recruiting participants into the trials. Research sponsors would be able to identify investigators with the requisite interest, knowledge and skills to provide a safe environment for participants (e.g., mores killed in anticipating and identifying problems related to potential complications for pregnant women or theirfetuses). These investigators would likely be located at facilities possessing specialized infrastructure for the evaluation of pregnant women and their fetuses, and the follow-up of neonates (e.g., fetal assessment units, high-risk obstetrical care and neonatal intensive care units). In addition, the specialized nature of stand-alone Phase I trials might assist with the recruitment of pregnant women by promoting an atmosphere of special care, attention and concern for monitoring the safety of pregnant women and their fetuses.