A blockchain framework for ensuring data quality in multi-organizational clinical trials

Abstract

The cost and complexity of conducting multi-site clinical trials have significantly increased over time, with site monitoring, data management, and Institutional Review Board (IRB) amendments being key drivers. Trial sponsors, such as pharmaceutical companies, are also increasingly outsourcing trial management to multiple organizations. Enforcing compliance with standard operating procedures, such as preserving data privacy for human subject protection, is crucial for upholding the integrity of a study and its findings. Current efforts to ensure quality of data collected at multiple sites and by multiple organizations lack a secure, trusted, and efficient framework for fragmented data capture. To address this challenge, we propose a novel data management infrastructure based on a permissioned blockchain with private channels, smart contracts, and distributed ledgers. We use an example multi-organizational clinical trial to design and implement a blockchain network: generate activity-specific private channels to segregate data flow for confidentiality, write channel-specific smart contracts to enforce regulatory guidelines, monitor the immutable transaction log to detect protocol breach, and auto-generate audit trail. Through comprehensive experimental study, we demonstrate that our system handles high-throughput transactions, exhibits low-latency, and constitutes a trusted, scalable solution.