title: Improving data transparency in clinical trials using blockchain smart contracts.
abstract: The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history.
authors.affiliation: Corporate Research and Development, Thomson Reuters, London, UK.
authors.forename: Timothy
authors.initials: T
authors.lastname: Nugent
authors.affiliation: Applied Innovation, Thomson Reuters, London, UK.
authors.forename: David
authors.initials: D
authors.lastname: Upton
authors.affiliation: Applied Innovation, Thomson Reuters, London, UK.
authors.forename: Mihai
authors.initials: M
authors.lastname: Cimpoesu
keywords: Blockchain; Clinical Trials; Ethereum; Missing Data; Smart Contract