Digital Imaging and Electronic Data Capture in Multi-Center Clinical Trials

Area of Science:

• Medical Informatics
• Clinical Trial Management
• Health Data Integration

Background:

• Medical image data is typically managed using digital imaging and communications in medicine (DICOM) within picture archiving and communication systems (PACS).
• Electronic data capture systems (EDCS) used in clinical trials currently lack seamless interfacing with PACS.
• This integration gap complicates trial workflows, leading to increased errors, time consumption, and operational costs.

Purpose of the Study:

• To analyze system architectures for integrating medical images into multi-center clinical trials.
• To address the challenges posed by the lack of PACS interfacing in EDCS.
• To propose an effective and open-source-based solution for improved image data integration.

Main Methods:

• Analysis of four distinct system architectures for medical image integration in multi-center trials.
• Evaluation of integration levels including data, function, visual, and context.
• Proposal of a novel architecture leveraging open-source components.

Main Results:

• Identification of limitations in current approaches to medical image integration in clinical trials.
• Demonstration of the feasibility of an open-source-based architecture.
• The proposed architecture integrates EDCS (OpenClinica), PACS (DCM4CHE), and a viewer (Weasis).

Conclusions:

• The proposed open-source architecture offers a viable solution for integrating medical images into clinical trials.
• This integration can significantly improve workflow efficiency and reduce errors and costs.
• Adoption of such systems is crucial for modernizing multi-center trial data management.