Implementing Federated Analysis Using DataSHIELD in the DREAM TO TREAT Atopic Dermatitis Registries Collaboration

Area of Science:

• Dermatology
• Health Informatics
• Data Science

Background:

• New biologic and small molecule treatments for atopic dermatitis (AD) require robust real-world evidence.
• Obtaining adequate patient data sample sizes for these therapies necessitates international collaboration.
• Existing national registries face challenges in data aggregation due to privacy and regulatory constraints.

Purpose of the Study:

• To assess the feasibility of an international registry collaboration for gathering real-world data on new systemic AD treatments.
• To establish a federated network enabling privacy-protected data analysis across multiple national registries.
• To ensure compliance with General Data Protection Regulation (GDPR) in international data sharing.

Main Methods:

• Deployment of an international DataSHIELD setup for federated analysis of harmonized data.
• Creation of a secure, privacy-preserving analysis environment across five European AD registries.
• Validation of federated analysis results through comparison with external analyses.

Main Results:

• Successful establishment of a five-country federated network for atopic dermatitis registries.
• Demonstration of DataSHIELD's capability for simultaneous, secure data analysis across registries.
• Validation confirmed the reliability of federated analysis outcomes.

Conclusions:

• DataSHIELD-based federated analysis is a feasible and valuable approach for dermatology research.
• The international TREAT Registry Taskforce successfully created a collaborative network for AD data.
• This model can be replicated for future international collaborations combining IT and medical resources.