AIM-GENDER: Understand and address barriers to pregnant women’s participation in clinical trials

 

Background

The findings from the ongoing broader Accelerating Innovation for Mothers (AIM) project demonstrated the glaring exclusion of pregnant women from drug and vaccine trials. There is a long history of this exclusion, and where women are included, they tend to be underrepresented compared to men. In the context of global health, the exclusion of pregnant women in low-and-middle income countries (LMIC) from clinical trials and development represents an intersectional ‘double disadvantage’, as both their gender and country of residence result in reduced agency and opportunity for participation in research that impacts their lives. We aim to explore the extent of gender bias related to the participation of pregnant women in clinical trials, at the intersection of the health system, health facility, health workers, and women through conducting a scoping review in addition to primary research in LMIC . Our objective is to identify and describe the “downstream” challenges and opportunities affecting the participation of pregnant women in clinical trials operating at the intersection of health systems and communities to inform strategies that can promote meaningful engagement of pregnant women at scale.