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.
Highlights
Clinical trials generate data used in the preparation of peer-reviewed journal papers and applications to regulatory bodies for approval of new treatments
Blockchain 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
This study aims to describe BlockTrial, a blockchain system for clinical trials management based on the Ethereum platform
Summary
Clinical trials generate data used in the preparation of peer-reviewed journal papers and applications to regulatory bodies for approval of new treatments. In both cases, the integrity of these data is important to numerous stakeholders, including academic researchers, journal editors and publishers, drug and device companies, government regulators, and most importantly, prospective patients and the general public. Considerable investment in research and development may be at stake along with the prospect of future earnings, both of which typically count in the billions of dollars Both publishers and regulators need to trust the data presented to them. Blockchain technology is emerging as an innovative tool in data and software security
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