JMIR Publications

ABSTRACT

Background:

Blockchain technologies have revolutionized the financial sector through their ability to generate immutable, cryptographically secure records. Clinical trials and healthcare data possess several synergies with that of the financial sector, specifically pertaining to the importance of tamper-resistant recording of processes. The evolution of Blockchain to autonomously execute tasks contingent upon predefined contractual terms via Smart Contracts allows a dynamic chain of interlinked events to unfold independently and in sequence, with time-stamped records. In recent years, mistrust in clinical trial data has grown significantly. Recording the entire clinical trial lifecycle from application, registration, recruitment to conduct, finance management, statistical analysis and reporting in an immutable cryptographically secure ledger with smart contract execution of trial processes could limit the potential for human intervention and tampering. This would produce a time-stamped record of all events within the trial lifecycle. Leveraging the capabilities of smart contracts could alleviate recruitment challenges and address ongoing concerns regarding data transparency, ownership, and integrity that currently undermine clinical trial processes

Objective:

This paper reviews the existing literature on smart contract applications in clinical trials and proposes a system architecture for utilizing smart contracts to automate key processes throughout the clinical trial lifecycle.

Methods:

A systematic search was conducted in accordance with the Preferred Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, identifying peer-reviewed studies and open-source repositories pertaining to the implementation of smart contracts in clinical trials. Data was extracted specific to the stage of the trial lifecycle described, smart contract architecture and technical specifications for real-world implementation. Data was synthesised to propose an architecture for automating clinical trial processes within the lifecycle using smart contracts

Results:

Following review, 10 studies met inclusion criteria, detailing the use of SCs in applications including but not limited to trial registration, trial conduct and protocol adherence. The review highlighted the role of SCs in decentralizing the trial recruitment process, with potential to significantly widen the pool of patients eligible to participate and opening up possibilities to recruit patients from under-represented groups increasing clinical trial equity and application of trial outcomes. Furthermore, increased patient ownership of data and dynamic data permissioning may lead to enhanced patient agency and public trust/participation. Finally, utilising SCs to provide oversight of trial finance management may optimise finance streams, patient reimbursement mechanisms and greater financial transparency.

Conclusions:

This review highlights the wide applicability of blockchain technology, specifically Smart Contracts in automating clinical trial processes. The SC trial lifecycle demonstrates that nearly all aspects of clinical trials could foreseeably be executed using SCs once initiated with minimal human interference. Greater data transparency, decentralized, inclusive patient recruitment and patient data ownership could enhance the applicability of clinical trials and increase the number that successfully meet recruitment timelines and complete with results that are reliable and trustworthy to the public. Clinical Trial: Not Applicable