Blockchain protocols in clinical trials: Transparency and traceability of consent

Abstract

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. Additionally, it removes the need for third parties, and gives participative control to the peer-to-peer users. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain; thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each revision of the protocol, consent was sought again. We obtained a single document, in a standard open format, that accounted for the whole consent collection process: timestamped consent status with regards to each version of the protocol. This document cannot be corrupted, and can be checked on any dedicated public website. It should be considered as a robust proof of data. In the future, we think that the complex data flow of a clinical trial can be tracked using Blockchain. Moreover, a blockchain core functionality, named Smart Contract, can help prevent clinical trial events not to happen in the right chronological order: including patients before they consented or analysing case report forms data before freezing the database. This will help reaching reliability, security, and transparency, and could be a consistent step towards reproducibility.

Perceived usefulness, ease of use and user acceptance of blockchain technology for digital transactions – insights from user-generated content on Twitter

“…The analysis indicates that smart contract is seen positively by users, in line with the literature which indicates the urgency of smart contract deployment in the financial and banking sectors (Cuccuru 2017), medical data storage and sharing (Roehrs, Da Costa, and Da Rosa Righi 2017;Xia et al 2017;Benchoufi, Porcher, and Ravaud 2017); and land regulations (Herian 2017;Zhang and Wen 2017). Instances of all these use cases were discussed on Twitter.…”

“…This is done within a decentralised ecosystem using a cryptographic mechanism (Werbach and Cornell 2017). Some characteristics of the smart contract Savelyev 2017 (Benchoufi, Porcher, and Ravaud 2017); and (e) solving principal-agent issues (Shermin 2017). There are challenges in replacing contract law by smart contracts (Savelyev 2017).…”

Real-time supply chain—A blockchain architecture for project deliveries

“…Although the application of blockchain technology in the supply chain and logistics is still at its initial phases, this technology can surely be remodelled and implemented in the supply and logistics sector [36,[38][39]. This technology is being implemented in more widely than others, starting from open manufacturing [25] and real estate in order to ensure fraud prevention [40] to clinical trials [41] and entrepreneurship innovation [35]. When adopting blockchain, supply chain managers are able to have safer, more transparent, traceable and efficient virtual transactions of their operational processes [34,36].…”

Diffusion of blockchain technology

“…OriginChain (Lu and Xu, 2017) software had been suggested in the literature which improves product traceability. Blockchain features making it popular in SERV industry: elimination of intermediaries (Seidel, 2018;Ying et al, 2018); distributed trust (Seidel, 2018); user anonymity (Mamais and Theodorakopoulos, 2017); user privacy (Mamais and Theodorakopoulos, 2017;Ouaddah et al, 2016;Xia et al, 2017;; user mobility (Hong et al, 2017;Yue et al, 2016;Zhang et al, 2016); time-stamped record creation and ownership (Hoy, 2017;O'Dair and Beaven, 2017); reproducibility (Benchoufi et al, 2017;McConaghy et al, 2017;O'Dair and Beaven, 2017); security (Benchoufi et al, 2017;Sharma, Singh, Jeong and Park, 2017;Ouaddah et al, 2016). Hainan Airlines (HNA) group had implemented a blockchain-enabled E-commerce platform for offering flexible benefit plans to their employees through digital coins (Ying et al, 2018).…”