- The benefits of the second option include: (i) full integration of pregnant women into the clinical research and regulatory
approval processes, which clearly signals the importance of normalizing the inclusion of pregnant women in research; (ii)
involvement of investigators who are familiar with the protocol as they will have participated in earlier research phases
with nonpregnant adults; (iii) reduced start-up costs and monitoring requirements; (iv) enhanced recruitment of pregnant
women; (v) the ability to generalize research data to the entire population, as pregnant and nonpregnant participants would
be drawn from the same population; (vi) the ability to provide pregnancy-specific data sooner than would be possible
with stand-alone trials because the subgroup analysis could be given priority; (vii) enhanced reporting of gender-specific
analyses among nonpregnant research participants and (viii) potentially increased statistical power.