A Proposed Framework to Address Needs of Clinical Data for Informed Medication Use in Pregnancy

Area of Science:

• Public Health
• Clinical Research
• Pharmacovigilance

Background:

• Limited data hinders clinical treatment decisions for medication use in pregnancy.
• Existing research and communication barriers impede data availability.
• This is a global public health concern requiring a coordinated approach.

Purpose of the Study:

• Propose a framework to address research limitations and communication barriers.
• Enhance data availability for medication use in pregnancy.
• Foster collaborative solutions among stakeholders.

Main Methods:

• Establish a cross-stakeholder coalition with multiple workstreams.
• Focus on awareness, cultural transformation, and collaboration initiatives.
• Develop research standards, data compilation, and new data capture methods.

Main Results:

• A proposed framework for collaborative data generation and collection is outlined.
• Key topic areas for focus are identified, including awareness and standards.
• Objectives to support these efforts are defined.

Conclusions:

• Collaboration among researchers, regulators, healthcare providers, and patients is crucial.
• Addressing communication and data gaps is essential for informed clinical decisions.
• The proposed framework aims to improve medication safety during pregnancy.