Performing research in pregnancy: Challenges and perspectives.

Area of Science:

• Dermatology
• Obstetrics
• Clinical Pharmacology

Background:

• Conducting clinical research during pregnancy faces significant ethical, logistical, and regulatory barriers.
• This results in a lack of data on the safety and efficacy of dermatologic treatments in pregnant individuals.
• Existing data often relies on animal studies, with limited human safety information available.

Purpose of the Study:

• To highlight the challenges in dermatologic research during pregnancy.
• To emphasize the importance of human data and pregnancy registries in evaluating medication safety.
• To advocate for increased dermatologist and patient participation in pregnancy registries.

Main Methods:

• Review of challenges in pregnancy research.
• Discussion of the evolution of the Food and Drug Administration (FDA) pregnancy labeling system.
• Analysis of the role and limitations of pregnancy registries.

Main Results:

• Paucity of human safety data for topical and systemic dermatologic therapies used in pregnancy.
• Recent FDA labeling revisions prioritize human data and registries over animal data.
• Low enrollment rates in pregnancy registries for dermatologic medications persist.

Conclusions:

• Dermatologists must address the knowledge gap regarding medication safety in pregnancy.
• Increased awareness and promotion of pregnancy registries are essential.
• Enhanced participation in registries will improve data on dermatologic drug use during pregnancy.