Using Blockchain Technology to Manage Clinical Trials Data: A Proof-of-Concept Study (Preprint)

Abstract

<sec> <title>BACKGROUND</title> Blockchain technology is emerging as an innovative tool in data and software security. </sec> <sec> <title>OBJECTIVE</title> This study aims to explore the role of blockchain in supporting clinical trials data management and develop a proof-of-concept implementation of a patient-facing and researcher-facing system. </sec> <sec> <title>METHODS</title> Blockchain-based Smart Contracts were built using the Ethereum platform. </sec> <sec> <title>RESULTS</title> We described BlockTrial, a system that uses a Web-based interface to allow users to run trials-related Smart Contracts on an Ethereum network. Functions allow patients to grant researchers access to their data and allow researchers to submit queries for data that are stored off chain. As a type of distributed ledger, the system generates a durable and transparent log of these and other transactions. BlockTrial could be used to increase the trustworthiness of data collected during clinical research with benefits to researchers, regulators, and drug companies alike. In addition, the system could empower patients to become more active and fully informed partners in research. </sec> <sec> <title>CONCLUSIONS</title> Blockchain technology presents an opportunity to address some of the common threats to the integrity of data collected in clinical trials and ensure that the analysis of these data comply with prespecified plans. Further technical work is needed to add additional functions. Policies must be developed to determine the optimal models for participation in the system by its various stakeholders. </sec>

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