FoPraNet-BW: An Infrastructure for Clinical Studies in Practice-Based Research Networks in the German Health System.

Area of Science:

• Health Informatics
• Primary Care Research
• Clinical Study Management

Background:

• General practice-based research networks are crucial for primary care medical knowledge.
• The German healthcare system presents unique challenges for digital health infrastructure.
• Limited digital connectivity and strict data protection regulations impact clinical study participation.

Purpose of the Study:

• To present a scalable IT infrastructure for enabling general practitioners (GPs) to conduct clinical studies.
• To address the specific constraints of the German health system for primary care research.
• To facilitate GP participation in studies based on their patient populations.

Main Methods:

• Development of a centralized study management server and local practice clients.
• Adaptation of the infrastructure to existing digital connectivity limitations.
• Consideration of data protection regulations and medical staff needs for study management.

Main Results:

• The IT infrastructure is operational in four university hospitals in Baden-Württemberg.
• Three clinical studies have been successfully completed or are ongoing.
• Over 70 GPs and 350 participants have been involved in conducted studies.

Conclusions:

• The presented IT infrastructure effectively supports clinical study participation for GPs in Germany.
• The system demonstrates scalability and adaptability to real-world primary care settings.
• Future clinical studies are planned, indicating the infrastructure's ongoing utility and potential.