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Using Blockchain Technology to Manage Clinical Trials Data: A Proof-of-Concept Study
David M Maslove1, Jacob Klein2, Kathryn Brohman3
1Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.
Blockchain technology enhances clinical trial data integrity and patient involvement. BlockTrial, a proof-of-concept system, uses smart contracts for secure data management, increasing trustworthiness for all stakeholders.
Area of Science:
- Computer Science
- Health Informatics
- Biotechnology
Background:
- Blockchain technology offers innovative solutions for data and software security.
- Emerging technologies are crucial for advancing clinical trial data management.
Purpose of the Study:
- To explore blockchain's role in clinical trial data management.
- To develop a proof-of-concept system (BlockTrial) for patient and researcher interaction.
- To enhance data integrity and patient engagement in clinical research.
Main Methods:
- Development of blockchain-based Smart Contracts using the Ethereum platform.
- Implementation of a Web-based interface for user interaction.
- Utilizing a distributed ledger for transaction logging.
Main Results:
- BlockTrial enables patients to control data access for researchers.
- Researchers can query off-chain data through the system.
- The system provides a durable, transparent log of transactions, enhancing data trustworthiness.
- BlockTrial empowers patients as active research participants.
Conclusions:
- Blockchain technology can mitigate threats to clinical trial data integrity.
- The system ensures data analysis aligns with prespecified plans.
- Further development is needed for enhanced functionality and stakeholder policy frameworks.
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