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Re-engineering a Clinical Trial Management System Using Blockchain Technology: System Design, Development, and Case

Yan Zhuang^1,2, Luxia Zhang^1,2, Xiyuan Gao³

¹National Institute of Health Data Science, Peking University, Beijing, China.

Journal of Medical Internet Research

|June 27, 2022

Summary

This study introduces a novel blockchain-based clinical trial management system (CTMS) to overcome data inconsistencies and inefficiencies in traditional systems. The new CTMS demonstrates enhanced security, efficiency, and auditability for clinical trial processes.

Keywords:

blockchain clinical trial management system clinical trials electronic data capture smart contract

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Area of Science:

Health Informatics
Distributed Ledger Technology
Clinical Trial Management

Background:

Current clinical trial management systems (CTMS) face fragmentation and data inconsistencies across sites, failing to meet expectations.
Blockchain technology offers unique features like transparency, immutability, and security to address CTMS challenges.

Purpose of the Study:

To re-engineer traditional CTMS by leveraging blockchain technology.
To develop a secure, auditable, efficient, and generalizable CTMS.

Main Methods:

Designed and implemented a comprehensive blockchain-based CTMS using Quorum blockchain for all clinical trial stages.
Included systems for trial master file, recruitment, electronic data capture, analytics, and payments.
Assessed feasibility, scalability, stability, and efficiency through case studies.

Main Results:

Successfully processed 21.6 million electronic data capture transactions with high throughput (335.4 TPS).
Automated patient matching for 1145 patients in 1.39 seconds using smart contracts.
Empirically validated key blockchain features like immutability and traceability.

Conclusions:

A comprehensive blockchain-based CTMS was successfully developed, covering all clinical trial phases.
The proposed system demonstrates superior performance and the potential of blockchain technology to revolutionize CTMS and healthcare tasks.