A Blockchain Framework for Managing and Monitoring Data in Multi-Site Clinical Trials

TL;DR

This paper introduces a blockchain-based framework for managing data in multi-site clinical trials, aiming to improve data integrity, privacy, and regulatory compliance while reducing administrative burdens.

Contribution

It presents a novel permissioned blockchain framework utilizing smart contracts and private channels for secure, automated data management in multi-site clinical trials.

Findings

Ensures compliance with IRB regulations across sites

Provides confidential data communication and protocol enforcement

Automates audit trails for data integrity

Abstract

The cost of conducting multi-site clinical trials has significantly increased over time, with site monitoring, data management, and amendments being key drivers. Clinical trial data management approaches typically rely on a central database, and require manual efforts to encode and maintain data capture and reporting requirements. To reduce the administrative burden, time, and effort of ensuring data integrity and privacy in multi-site trials, we propose a novel data management framework based on permissioned blockchain technology. We demonstrate how our framework, which uses smart contracts and private channels, enables confidential data communication, protocol enforcement, and and an automated audit trail. We compare this framework with the traditional data management approach and evaluate its effectiveness in satisfying the major requirements of multi-site clinical trials. We show that our framework ensures enforcement of IRB-related regulatory requirements across multiple sites and stakeholders.