Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials; Public Meeting
February 2 - 3, 2021
- February 2 - 3, 2021
This public meeting will be held on February 2, 2021, from 12 p.m. to 4 p.m. Eastern Time and February 3, 2021, from 12 p.m. to 3 p.m. Eastern Time.
This public workshop is currently being scheduled and planned as a virtual meeting. The Food and Drug Administration is announcing a public meeting that will be convened by Duke University’s Robert J. Margolis Center for Health Policy and supported by a cooperative agreement with FDA. The meeting, entitled “Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials,” is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant people in clinical trials for drug development.
ABOUT THE PUBLIC WORKSHOP
The U.S Food and Drug Administration (FDA), under a cooperative agreement with Duke-Margolis Center for Health Policy, 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 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.
To register for the public meeting, please visit the following website: https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials.
Registration for this event is free and mandatory. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registrants will receive confirmation once they have been accepted. Registered participants will be sent technical system requirements in advance of the event. We recommend that you review these technical system requirements prior to joining the virtual public meeting. The meeting will be recorded, and the recording will be available after the meeting.
FEDERAL REGISTER NOTICE
The Federal Register Notice FDA-2020-N-0001 is accessible here.
A full agenda will be available before the workshop. All other meeting materials, including speaker slides and transcripts, will be available here before and after the workshop. Please visit this page for any updates.
Transcripts: Please be advised that transcripts of the public meeting will be available by February 8, 2021, at the event page here.
EVENT POINT OF CONTACT
Catherine Sewell, at Catherine.Sewell@fda.hhs.gov, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5360, Silver Spring, MD 20993-0002, Fax: 301-796-9897.
|Agenda Clinical Trials In Pregnancy||pdf (259.93 KB)|