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Evaluation

Workshop/Symposium

Session: Symposia & Workshops: Session 4

Back to the Source: a Review of the Current State of Social Determinants of Health in European and US Real World Data Sources

Wednesday, August 28, 2024
10:30 AM – 12:00 PM CEST
Location: Room IV

Background:
Europe and the United States (US) are home to diverse populations. Real-world data (RWD) sources provide opportunities to describe social determinants of health (SDoH) and the pathways by which they affect health. Yet, the quality and availability of SDoH data in European and US RWD varies. Given the growing scientific and regulatory interest and guidance on representative studies, SDoH variables in RWD sources should be available, robust, and reliable.

Objectives:
• Provide an overview of the current regulatory landscape on the inclusion of SDoH variables in European- and US- specific RWD sources.
• Review the state (including availability, consistency, and accuracy) of SDoH variables in commonly used and well-known European and US RWD sources and discuss impact on conducting representative research using RWD.
• Discuss potential solutions to address the lack of reliable and informative SDoH variables in RWD sources, with commentary on specific geographic considerations.
This symposium will benefit all researchers by improving understanding of the necessary and ongoing research in this space. This topic is not just for people interested in Health Equity, it necessary for all to understand the widespread impacts on all aspects of pharmacoepidemiologic research.

Description:
In this ISPE Health Equity SIG supported symposium, we will review the state of SDoH data in commonly used and well-known Europe and US RWD sources and discuss solutions to address shortcomings in these data. It will be presented by European and US industry members, academics, and regulators, all of whom are major stakeholders and users of RWD sources.
• Introduction of session and SDoH (A.F. Marcus (ISPE Health Equity SIG Chair – US Industry), E. Vallejo-Yagüe (EU-Academia)) (15 min.)
• Present an overview of the current state of collecting and including SDoH data in Europe and the US (T. Lasky (US Regulatory-Retired), E. Vallejo-Yagüe (EU-Academia), E. Dareng (UK-Industry)) (25 min.)
• Review and interpret the state (including availability, consistency, and accuracy) of SDoH variables in commonly used and well-known European and US RWD sources and discuss impact on conducting representative research with RWD (D. Umuhire (EU-Regulatory), T. Ochi (EU-Academia), S. Phillips (US-Service Provider), E. Dareng (UK-Industry)). (30 min.)
• Panel discussion of current and long-term solutions and strategies to address gaps in the availability of reliable and granular SDoH variables, including specific uses, with strengths, limitations, and biases in existing RWD sources and networks. Lastly, issuance of call to action and next steps. (Moderator: I. Mehta (US Industry), Panelists: D. Umuhire, T. Ochi, E. Dareng, S. Phillips, A. F. Marcus) (20 min.)