Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials

Event Background

Pregnant people have historically been excluded from clinical trials for new and existing therapeutics, but many still use medically necessary drugs during the course of pregnancy.[1] Clearer scientific understanding of the risks and benefits associated with the use of medications during pregnancy, for pregnant people and their developing fetuses, is essential to the safe and effective management of chronic and acute medical conditions experienced during pregnancy. Even as the scientific community has begun to acknowledge the importance of conducting clinical trials during pregnancy, barriers to clinical research remain. Increasing researcher awareness of the requirements and prospective approaches for the conduct of clinical trials in pregnancy can facilitate therapeutic development to address unmet medical need in the pregnant population.

Accordingly, the Duke-Margolis Center for Health Policy , under a cooperative agreement with the U.S. Food and Drug Administration (FDA), is convening this public meeting to discuss the need for clinical research in this complex population as well as scientific and ethical considerations for the inclusion of pregnant people in clinical trials. 

The meeting will explore topics including:

• Regulatory, scientific, and ethical considerations for the enrollment of pregnant people in clinical research, as articulated in existing FDA Guidance;
• Priority areas of unmet need for clinical data collection and therapeutic development in obstetrics;
• Characteristics of a standard nonclinical program designed to assess the safety of a product in the antenatal period; and,
• Clinical trial designs for studies enrolling pregnant people to evaluate the safety and efficacy of therapeutics for chronic or acute medical conditions that require treatment during pregnancy.

Funding for this workshop was made possible in part by a cooperative agreement from the U.S. Food and Drug Administration Center for Drug Evaluation and Research. The views expressed in written workshop materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.

[1] U.S. Food and Drug Administration. Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry - Draft Guidance. 2018.