Establishing an Interoperable Clinical Trial Information System Within MIRACUM

Area of Science:

• Medical Informatics
• Clinical Trial Management
• Health Data Interoperability

Background:

• Efficient patient recruitment is crucial for clinical trials.
• Integrating clinical trial information with routine health records offers significant potential.
• A decentralized approach is needed for large German healthcare consortia like MIRACUM.

Purpose of the Study:

• To develop an interoperable clinical trial registry (CTR) system for the MIRACUM consortium.
• To facilitate straightforward patient recruitment by linking clinical trial data to routine health records.
• To enable automated data provision from site-specific CTRs to a central MIRACUM-wide registry.

Main Methods:

• Surveyed existing trial information systems at partner sites.
• Compared functionalities of current systems.
• Developed a joint requirement specification and a minimal core dataset.
• Designed an architecture allowing autonomous system decisions and cooperative enhancement.

Main Results:

• A new open-source clinical trial registry (CTR) was developed.
• The CTR supports modular, site-specific add-ons.
• The system ensures cross-site interoperability for automated data provision.
• Sites without existing registries can be supported by others, creating synergies.

Conclusions:

• The developed CTR enables effective linking of clinical trial information to routine health records.
• Cross-site interoperability is a key feature for consortium-wide data integration.
• The system supports efficient patient recruitment and data management within the MIRACUM network.