SwissPK^cdw - A clinical data warehouse for the optimization of pediatric dosing regimens

Area of Science:

• Pharmacokinetics
• Clinical Data Management
• Pediatric Pharmacology

Background:

• Limited pharmacokinetic data exists for pediatric patients, hindering accurate drug dosage recommendations.
• Existing clinical trial data primarily focuses on adult populations.
• Pharmacokinetic (PK) modeling offers a potential solution to bridge this data gap.

Purpose of the Study:

• To establish a secure data infrastructure, the Swiss Pharmacokinetics Clinical Data Warehouse (SwissPKcdw), for pediatric pharmacokinetic research.
• To facilitate secure data sharing and collaboration between healthcare providers and academic researchers.
• To enable the use of routinely collected clinical data for PK modeling in pediatric populations.

Main Methods:

• Implementation of a secure Clinical Data Warehouse (CDW) within the BioMedIT network.
• Development of a regulatory framework for data transfer and utilization.
• Utilizing modular, containerized, and open-source components for flexibility and reusability.
• Integration of data from various providers and researchers.

Main Results:

• Successful implementation of the SwissPKcdw infrastructure through interprofessional collaboration.
• Demonstration of a real-world use case involving pediatric blood sample analysis for genetic polymorphisms.
• Aggregation and analysis of genetic polymorphism data with health-related patient data within the SwissPKcdw.
• Validation of the secure data environment for collaborative research.

Conclusions:

• The SwissPKcdw provides a robust and secure platform for pediatric pharmacokinetic research.
• The infrastructure enables the integration of real-world clinical data for PK modeling.
• This collaborative approach enhances the availability of essential information for pediatric drug therapy.
• The modular design allows for adaptation to similar data integration and analysis projects.