METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

Area of Science:

• Health Informatics
• Blockchain Technology
• Clinical Trial Management

Background:

• Dynamic consent is crucial for data integrity in clinical trials.
• Blockchain technology offers a potential solution to enhance data integrity in consent processes.

Purpose of the Study:

• To develop and evaluate a blockchain-based dynamic consent platform (METORY) for clinical trials.
• To address data integrity challenges in clinical trials through a demand-driven development approach.

Main Methods:

• Developed METORY, a platform integrating web/mobile UI, study management, and blockchain (Hyperledger Fabric).
• Implemented identity and role-based access control using mobile certificates and Hyperledger Fabric.
• Employed SHA-256 encryption, TLS protocol, and file-system encryption for data security.

Main Results:

• User acceptance tests were conducted, and feedback was incorporated for platform improvement.
• The platform successfully integrated blockchain for enhanced data integrity in dynamic consent.
• Security measures included robust encryption and access control mechanisms.

Conclusions:

• METORY provides a feasible and secure blockchain-based solution for dynamic consent in clinical trials.
• The platform demonstrated acceptable ease of use and usefulness in user experience evaluations.
• This approach enhances data integrity and patient control in clinical research.