Good practices for clinical data warehouse implementation: A case study in France.

Area of Science:

• Health Informatics
• Data Management
• Clinical Research Infrastructure

Background:

• Real-world data (RWD) offers significant potential for enhancing patient care quality.
• Effective utilization of RWD necessitates specialized infrastructures and methodologies for knowledge derivation and innovation.
• Clinical Data Warehouses (CDWs) are crucial for managing and leveraging RWD.

Purpose of the Study:

• To analyze the key aspects of modern CDWs in French regional and university hospitals.
• To identify essential components for robust CDW implementation, including governance, transparency, data types, reuse, tools, documentation, and quality control.
• To derive general guidelines for optimizing CDW functionality for research and clinical innovation.

Main Methods:

• A national case study involving 32 French regional and university hospitals.
• Semi-structured interviews conducted between March and November 2022.
• A review of reported studies on French CDWs.

Main Results:

• 14 out of 32 hospitals have a CDW in production, with 5 experimenting and 5 having prospective projects.
• CDW implementation in France began in 2011 and accelerated in late 2020.
• Key areas for improvement include governance stabilization, data schema standardization, data quality, and documentation.

Conclusions:

• CDWs require strengthened governance, standardized data, and enhanced quality/documentation for research orientation.
• Sustainability of CDW teams and multilevel governance are critical success factors.
• Increased transparency in studies and data transformation tools are vital for multicentric data reuse and routine care innovation.