Managing Clinical Research on Blockchain Using FAIR Principles

Abstract

Blockchain technology has the potential to extend beyond its traditional use in cryptocurrency and make significant strides in critical sectors like healthcare. Clinical research, which plays a pivotal role in enhancing healthcare quality by guiding activities, determining equipment usage, and recommending preferred medications, stands to benefit greatly from blockchain integration. The unique technical capabilities of blockchain offer promising solutions across various phases of clinical research, from study design and patient recruitment to report study findings. By addressing current challenges in the clinical research process, blockchain technology can notably enhance research quality and, consequently, improve patient care. Although conceptual framework studies regarding blockchain technology are in the available literature, practical implementations of this technology remain relatively scarce. Thus, in this study, a private permissioned Hyperledger Fabric blockchain platform was developed to manage clinical research. As a use case, a blockchain-based distributed framework for counting and reporting COVID-19 epidemiological parameters and statistics among healthcare centers has been defined in the study. Besides, to make clinical research data findable, accessible, interoperable, and reusable (FAIR), we integrated FAIR principles into the developed blockchain-based clinical research management system. Additionally, a use case logic has been implemented as a smart contract (chaincode) and invoked on Fabric Network. This study, in general, represents a crucial step towards bridging the gap between theoretical understanding and real-world application within the domain of blockchain technology. Moreover, the performance of the Fabric Network was evaluated by analyzing the chain code execution performance according to the size of the patient data. By deploying a functioning clinical research network and executing smart contracts, this study contributes to the practical utilization of blockchain technology along with FAIR principles integration to the entire clinical research process, which is a first in the literature.