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. 2016 Oct 20:5:2541.
doi: 10.12688/f1000research.9756.1. eCollection 2016.

Improving data transparency in clinical trials using blockchain smart contracts

Timothy Nugent  1 , David Upton  2 , Mihai Cimpoesu  2
Affiliations

Improving data transparency in clinical trials using blockchain smart contracts

Timothy Nugent et al. F1000Res. .

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.

Keywords: Blockchain; Clinical Trials; Ethereum; Missing Data; Smart Contract.

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Conflict of interest statement

Competing interests: The authors are employees of Thomson Reuters.

Figures

Figure 1.
Figure 1.. A private blockchain network consisting of regulators, pharma and contract research organisations.
The system is composed of a hierarchical arrangement of two core types of smart contract - regulator contracts and trial contracts - with subjects and their associated clinical measurements appended to a container within the trial contract. The logic within the trial contract effectively enforces aspects of the trial protocol, ensuring that neither subjects nor measurements are appended outside of the predetermined trial timelines, while the tamper resistant characteristics of the blockchain prevent data manipulation.
See this image and copyright information in PMC

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