Contemporary Practice and Considerations for Real-World Data Source Identification and Feasibility Assessment

Area of Science:

• Pharmacoepidemiology
• Regulatory Science
• Health Data Analytics

Background:

• Rapid growth in real-world data (RWD) sources necessitates clear guidance for regulatory use.
• Existing regulatory documents offer guidance for assessing RWD suitability in pharmacoepidemiology.

Purpose of the Study:

• To assess differences in RWD guidance across regions (US, EU, Asia-Pacific).
• To evaluate variability in current practices for identifying and assessing RWD for regulatory studies.

Main Methods:

• Mapped 11 RWD guidance documents against 14 key assessment criteria.
• Conducted an online survey of International Society for Pharmacoepidemiology members on current RWD practices.
• Analyzed RWD identification methods and referenced guidance documents.

Main Results:

• Variability observed in RWD assessment criteria across guidance documents.
• 37 respondents utilized RWD for post-marketing commitments and background epidemiology.
• Literature and data landscaping were primary RWD identification methods; FDA, ENCePP, and EMA were frequently referenced guidelines.
• Challenges included RWD accessibility, validation, and provider responsiveness.

Conclusions:

• Existing RWD guidelines are widely used but lack consistent reflection of key assessment criteria.
• Persistent challenges in RWD feasibility assessments require further attention and potential refinement of guidance.