As part of our ongoing work to increase women’s participation in medical research and diversity in clinical trials, WomenHeart weighed in with the Food and Drug Administration (FDA) this summer in response to two opportunities.
On August 6, we submitted comments related to increasing diversity in clinical trials. We recommended that FDA clearly define diversity in order to ensure that clinical trials include a truly representative sample of those who would benefit from the therapy being tested, including women and racial and ethnic groups who may be disproportionately impacted. In addition, we asked for data to be collected and reported in such a way that clinicians can compare results between groups – for example, between women of different ethnicities – and so that researchers can have a full picture of the female trial participants’ health history, including issues related to pregnancy, hormone therapy, menstruation, etc.
Furthermore, we agreed with FDA that researchers designing clinical trials must address challenges to participation, including transportation and financial barriers. We recommended that they also consider caregiving responsibilities that may act as barriers for women who are caring for children, family members, or other older adults.
In July, we submitted comments related to enhanced research of pregnant and lactating women to assess the impact of medications on their health. Not only is heart disease the leading cause of death in pregnant women, but heart disease in pregnant women is on the rise. It is critical that we understand the impact of various medications on women when they are pregnant so providers can safely and effectively treat their heart disease, along with their pregnancy and any other medical condition. Accordingly, we asked FDA to be clear that pregnant women’s health should always be a factor in this research, in addition to pregnancy outcomes and infant health.