FDA/Duke Virtual Public Meeting - Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials, February 2-3, 2021

The following may be of interest to BDRP members.

The US FDA and the Duke Margolis Center for Health Policy will be hosting a 2-day virtual public meeting on Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.

Per the Federal Register Notice posted by FDA, input from this meeting may also help further inform the finalization of FDA’s draft guidance entitled “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.”

Date: February 2, 2021 12:00PM – 3:45PM  & February 3, 2021 12:00PM - 3:15PM

Draft Agenda may be downloaded here (member login required).

Registration link  (registration is free)

Event Background

Pregnant women have historically been excluded from clinical trials for new and existing therapeutics, but many women still use medically necessary drugs during the course of pregnancy. Clearer scientific understanding of the risks and benefits associated with the use of medications during pregnancy, for pregnant women 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 webinar to discuss the need for clinical research in this complex population as well as scientific and ethical considerations for the inclusion of pregnant women in clinical trials. The meeting will explore topics including:

  • Regulatory, scientific, and ethical considerations for the enrollment of pregnant women 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 women to evaluate the safety and efficacy of therapeutics for chronic or acute medical conditions that require treatment during pregnancy.



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