Missed Trials, Future Opportunities

Abstract

Pregnant women deserve more from clinical research. Justice requires a research agenda that adequately addresses the health needs of pregnant women, and fair inclusion criteria that support the safe and responsible participation of pregnant women in relevant research. In recent years, there have been successful global efforts to expand paediatric clinical research and to achieve appropriate gender balance in clinical trials. Significant challenges remain, however, with respect to the fair inclusion of pregnant women in clinical research. Indeed, pregnant women continue to be routinely excluded from such research without justification beyond the generic beliefs that vulnerable foetuses must be protected from research-related harm and that one effective way to meet this obligation is to exclude pregnant women from clinical research.