SW-2F - Overcoming Challenges in CDM Harmonization from Within-Country Coordination to International Collaboration

Background: The Common Data Model (CDM) approach plays a crucial role in enabling standardized, reproducible, and scalable real-world evidence generation across diverse healthcare systems. By providing a structured framework, CDMs facilitate cross-institution and cross-country collaborations, supporting regulatory and clinical decision-making. However, despite its advantages, the harmonization process remains a significant challenge due to variations in datasets and requires substantial effort to align their differences.

Objectives: This symposium will explore the complexities of harmonizing healthcare databases across different levels of collaboration—from within-country coordination to international integration—highlighting key challenges and potential solutions for achieving effective CDM implementation.

Description: This symposium plans to invite four distinguished speakers leading major CDM initiatives, representing a progression from within-country CDM implementations to international collaborations:
• Dr. Kristian B. Filion (CNODES, Canada) [15 mins] – Discussing data access and quality challenges in cross-province collaboration in Canada or even the other national networks, highlighting the standardization efforts needed for CDM-based data in regulatory use.
• Dr. Ashley I. Michnick (FDA Sentinel, USA) [15 mins] – Sharing insights on harmonizing lab-related data, which varies significantly across databases—particularly in electronic health records (EHRs)—and discussing strategies to align diverse laboratory records for real-world evidence generation.
• Dr. Daniel Prieto-Alhambra (DARWIN EU, Europe) [15 mins] – Focusing on the creation of a network of data partners and expertise to generate reliable real world evidence to inform regulatory decision making in the European Union.
• Mr. Chin-Yao Shen (Asian CDM Network) [15 mins] – Highlighting the difficulties of harmonizing databases across highly diverse healthcare systems in Asia and presenting the study-specific CDM approach as a solution to accommodate regional variations in data structures.
Following the presentations, we will hold a panel discussion [15 mins], where speakers will engage in a conversation on:
1. Evaluating data heterogeneity – Determining which types of heterogeneity are appropriate for harmonization and which should be preserved to maintain data integrity.
2. Governance and maintenance of CDM networks – Strategies to ensure long-term sustainability and collaborative governance among data partners.
The symposium will conclude with a 15-minute Q&A session, providing an opportunity for the audience to engage with the speakers and discuss key insights from the presentations and panel discussion.