Inclusion of women who are pregnant, lactating, or of reproductive potential in clinical trials: health, ethical, and regulatory considerations

Randomised controlled trials have commonly excluded women who are pregnant, lactating, or of reproductive potential. When there is clinical equipoise, the exclusion of these women raises concerns regarding the principles of autonomy, beneficence, and justice. This exclusion also shifts evidence generation from the monitored setting of randomised controlled trials to clinical settings, where data can take several years to accrue. Here, we highlight key health, ethical, scientific, and regulatory considerations surrounding the inclusion of women who are pregnant, lactating, or of reproductive potential in clinical trials to guide further discussions. We offer recommendations for a judicious approach to inclusivity, highlighting regulatory, sponsor, and clinical trial design considerations. We highlight the need for patient engagement and interdisciplinary discourse throughout the research lifecycle.