Using Blockchain Technology to Manage Clinical Trials Data: A Proof-of-Concept Study

Abstract

BackgroundBlockchain technology is emerging as an innovative tool in data and software security.ObjectiveThis study aims to explore the role of blockchain in supporting clinical trials data management and develop a proof-of-concept implementation of a patient-facing and researcher-facing system.MethodsBlockchain-based Smart Contracts were built using the Ethereum platform.ResultsWe described BlockTrial, a system that uses a Web-based interface to allow users to run trials-related Smart Contracts on an Ethereum network. Functions allow patients to grant researchers access to their data and allow researchers to submit queries for data that are stored off chain. As a type of distributed ledger, the system generates a durable and transparent log of these and other transactions. BlockTrial could be used to increase the trustworthiness of data collected during clinical research with benefits to researchers, regulators, and drug companies alike. In addition, the system could empower patients to become more active and fully informed partners in research.ConclusionsBlockchain technology presents an opportunity to address some of the common threats to the integrity of data collected in clinical trials and ensure that the analysis of these data comply with prespecified plans. Further technical work is needed to add additional functions. Policies must be developed to determine the optimal models for participation in the system by its various stakeholders.

Blockchain in Health Care: Hope or Hype?

“…Blockchain technology is not new; however, exploring the feasibility of blockchain applications for the health care sector is in its infancy. The current state of innovating with blockchain in health care is in the proof-of-concept phase [ 8 , 58 ]. Blockchain is a technological innovation that brings benefits and challenges [ 42 ].…”

“…Blockchain is a technological innovation that brings benefits and challenges [ 42 ]. The health care sector is expected to benefit from blockchain in terms of empowering patients and increasing immutability and traceability [ 11 , 41 , 58 ]. The needs of the health care sector include sharing vast amounts of patient health data across involved entities (ie, interoperability), regulatory compliance (eg, GDPR), data confidentiality, data integrity, privacy, and data and service availability.…”

“…In the case of using patient-generated health data for research purposes, smart contracts enable patients to give consent and permission for researchers to access their health data [ 58 ]. However, data integrity can be compromised, as the patient data entry point, which is the patient’s device, can be used to impersonate the patient [ 59 ].…”

Blockchain Compliance by Design: Regulatory Considerations for Blockchain in Clinical Research

“…Research participants and research staff make many data entry errors, reflecting the conundrum of "garbage in, garbage out" (Learney, 2019). To ensure that research data are accurate, blockchain prototypes are exploring integrating the immutable blockchains with other off-chain database systems (Shae and Tsai, 2017;Dai et al, 2018;Maslove et al, 2018) where stored data, such as images, are linked to the chain by uniform resource locators (Patel, 2018). Additionally, many emerging clinical research blockchain applications are not yet addressing the data standardization and scalability available in traditional databases (McGhin et al, 2019).…”

Challenges Blockchain Technology and Initial Coin Offering ICO in Healthcare from Legal Perspectives

“…Using this mechanism could increase patients' trust in the system and could facilitate data analysis. Each of the data can be summarised to compile the result for the clinical step level 67 . Generally, criminals cannot manipulate relevant data in blockchain network 68 .…”