Pregnant Participants in Clinical Trials

Excluding pregnant and breastfeeding persons from clinical research has resulted in a significant deficiency of crucial dosing and safety data, leading to incomplete or non-existing information for healthcare professionals and patients at the time of drug approval. Women are entitled to explicit, evidence-based guidance to manage their diseases and chronic conditions during pregnancy and lactation, ensuring the best possible outcomes for both their health and that of their newborn.

Explanations on the ethical considerations supporting the inclusion of pregnant individuals in clinical research brought attention to the removal of the outdated classification of pregnant individuals as a vulnerable population. Several institutions and regulatory agencies have responded to recent developments with initiatives to enhance the participation of pregnant and lactating individuals in clinical studies.

This webinar will cover recent and ongoing efforts to increase the inclusion of pregnant and lactating individuals in clinical trials. The expert speakers will examine new guidance under development, existing and proposed guidances and the FDA’s PDUFA VII commitments to establish a framework for pregnancy safety studies.

Register for this webinar to explore how the inclusion of pregnant and lactating individuals in clinical trials is transforming healthcare outcomes.

Host or Publisher Xtalks