Challenges and Solutions in Implementing eSource Technology for Real-World Studies in China: Qualitative Study Among...

Area of Science:

• Clinical Research Informatics
• Health Data Management
• Digital Health

Background:

• eSources streamline clinical research by utilizing electronic data from sources like EHRs and wearable devices.
• Potential benefits include enhanced data accuracy, improved patient safety, and reduced clinical trial costs.
• A 2020 opinion study highlighted challenges and a roadmap for eSource technology in clinical research.

Purpose of the Study:

• To identify challenges and propose solutions for implementing eSource technology in real-world clinical studies.
• To share experiences and lessons learned from an electronic source record (ESR) project.

Main Methods:

• Developed a prototype of ESR software for systematic demonstration.
• Conducted in-depth interviews with 25 stakeholders from regulatory authorities, pharmaceutical companies, hospital IT, medical system providers, and clinicians.
• Gathered guidance and suggestions for eSource implementation.

Main Results:

• Existing EHR systems often cannot meet the diverse demands of eSources, necessitating specialized solutions like ESRs.
• ESRs aim to alleviate the burden on hospital IT departments overwhelmed by EHR system requirements.
• The research emphasized multidisciplinary input and considered complexities in data collection, processing, quality control, and application.

Conclusions:

• The study outlines stakeholder requirement dependencies, challenges, and recommendations for designing ESR software for eSource implementation in China.
• Experiences from ESR projects offer insights for advancing the eSource research field.
• Future research should include patient perspectives and involve additional stakeholders like community health providers.