The COVID-19 pandemic necessitated the emergence of Decentralized Clinical Trials (DCTs) due to patientretention, accelerating trials, improving data accessibility, enabling virtual care, and facilitating seamlesscomm...The COVID-19 pandemic necessitated the emergence of Decentralized Clinical Trials (DCTs) due to patientretention, accelerating trials, improving data accessibility, enabling virtual care, and facilitating seamlesscommunication through integrated systems. However, integrating systems in DCTs exposes clinical data to potentialsecurity threats, making them susceptible to theft at any stage, a high risk of protocol deviations, andmonitoring issues. To mitigate these challenges, blockchain technology serves as a secure framework, acting as adecentralized ledger, creating an immutable environment by establishing a zero-trust architecture, where dataare deemed untrusted until verified. In combination with Internet of Things (IoT)-enabled wearable devices,blockchain secures the transfer of clinical trial data on private blockchains during DCT automation and operations.This paper proposes a prototype model of the zero-Trust Architecture Blockchain (z-TAB) to integratepatient-generated clinical trial data during DCT operation management. The EigenTrust-based PracticalByzantine Fault Tolerance (T-PBFT) algorithm has been incorporated as a consensus protocol, leveragingHyperledger Fabric. Furthermore, the IoT has been integrated to streamline data processing among stakeholderswithin the blockchain platforms. Rigorous evaluation has been done for immutability, privacy and security,mutual consensus, transparency, accountability, tracking and tracing, and temperature‒humidity controlparameters.展开更多
文摘The COVID-19 pandemic necessitated the emergence of Decentralized Clinical Trials (DCTs) due to patientretention, accelerating trials, improving data accessibility, enabling virtual care, and facilitating seamlesscommunication through integrated systems. However, integrating systems in DCTs exposes clinical data to potentialsecurity threats, making them susceptible to theft at any stage, a high risk of protocol deviations, andmonitoring issues. To mitigate these challenges, blockchain technology serves as a secure framework, acting as adecentralized ledger, creating an immutable environment by establishing a zero-trust architecture, where dataare deemed untrusted until verified. In combination with Internet of Things (IoT)-enabled wearable devices,blockchain secures the transfer of clinical trial data on private blockchains during DCT automation and operations.This paper proposes a prototype model of the zero-Trust Architecture Blockchain (z-TAB) to integratepatient-generated clinical trial data during DCT operation management. The EigenTrust-based PracticalByzantine Fault Tolerance (T-PBFT) algorithm has been incorporated as a consensus protocol, leveragingHyperledger Fabric. Furthermore, the IoT has been integrated to streamline data processing among stakeholderswithin the blockchain platforms. Rigorous evaluation has been done for immutability, privacy and security,mutual consensus, transparency, accountability, tracking and tracing, and temperature‒humidity controlparameters.
