Abstract
Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use raw data from a real completed clinical trial, simulate the trial onto a proof of concept web portal service, and test its resilience to data tampering. We also assess its prospects to provide a traceable and useful audit trail of trial data for regulators, and a flexible service for all members within the clinical trials network. We also improve the way adverse events are currently reported. In conclusion, we advocate that this service could offer an improvement in clinical trial data management, and could bolster trust in the clinical research process and the ease at which regulators can oversee trials.
Highlights
We show a simulation of how different types of clinical trial events were implemented using our blockchain-based data portal
We composed truncated and digitized case report form (CRF) for the four patients we mimicked on the portal using the publicly available CRF component data
If the CRF were paper based, it would be scanned in; if electronically captured, it would be directly added to the growing blockchain via the portal, as is the case in our simulation
Summary
We built a proof of concept web portal to access a trial-specific blockchain. The portal was built using a Python and Django software development framework, with additional Python encryption libraries, including hashlib and simplecrypt. The portal is hosted on the cloud platform Heroku. A proof of concept prototype of the portal can be found at: http://trialchain.ucsf.edu/. This implementation of the service we are proposing is meant as a proof of concept and is not designed for production usage
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