Disadvantaged, outnumbered, and discouraged: women’s experiences as healthy volunteers in U.S. Phase I trials

ABSTRACTWhile enormous strides have been made in the representation of women in clinical trials, the percentage of women enrolling in Phase I trials still remains low, which both raises public health concerns about the safety of new drugs and social justice concerns regarding their inclusion in research. As part of a longitudinal study of healthy volunteers in the United States, our inquiry aimed to examine impediments to women enrolling in Phase I trials as well as their experiences participating in these studies at residential research clinics. We analyzed 111 semi-structured interviews conducted with 47 women who had enrolled in at least one Phase I trial. Our study indicates that women face discrimination during all stages of their participation in Phase I trials from their ability to qualify for studies, the treatment they receive in the clinic facilities, and a lack of social support. Specifically, we found that (1) study designs disadvantage participants of childbearing potential, (2) women feel vu...