TrialChain: A Blockchain-Based Platform to Validate Data Integrity in Large, Biomedical Research Studies

The governance of data used for biomedical research and clinical trials is an important requirement for generating accurate results. To improve the visibility of data quality and analysis, we developed TrialChain, a blockchain-based platform that can be used to validate data integrity from large, biomedical research studies. We implemented a private blockchain using the MultiChain platform and integrated it with a data science platform deployed within a large research center. An administrative web application was built with Python to manage the platform, which was built with a microservice architecture using Docker. The TrialChain platform was integrated during data acquisition into our existing data science platform. Using NiFi, data were hashed and logged within the local blockchain infrastructure. To provide public validation, the local blockchain state was periodically synchronized to the public Ethereum network. The use of a combined private/public blockchain platform allows for both public validation of results while maintaining additional security and lower cost for blockchain transactions. Original data and modifications due to downstream analysis can be logged within TrialChain and data assets or results can be rapidly validated when needed using API calls to the platform. The TrialChain platform provides a data governance solution to audit the acquisition and analysis of biomedical research data. The platform provides cryptographic assurance of data authenticity and can also be used to document data analysis.