Ensuring protocol compliance and data transparency in clinical trials using Blockchain smart contracts

Abstract

Background: Clinical Trials (CTs) help in testing and validating the safety and efficacy of newly discovered drugs on specific patient population cohorts. However, these trials usually experience many challenges, such as extensive time frames, high financial cost, regulatory and administrative barriers, and insufficient workforce. In addition, CTs face several data management challenges pertaining to protocol compliance, patient enrollment, transparency, traceability, data integrity, and selective reporting. Blockchain can potentially address such challenges because of its intrinsic features and properties. Although existing literature broadly discusses the applicability of blockchain-based solutions for CTs, only a few studies present their working proof-of-concept. Methods: We propose a blockchain-based framework for CT data management, using Ethereum smart contracts, which employs IPFS as the file storage system to automate processes and information exchange among CT stakeholders. CT documents stored in the IPFS are difficult to tamper with as they are given unique cryptographic hashes. We present algorithms that capture various stages of CT data management. We develop the Ethereum smart contract using Remix IDE that is validated under different scenarios. Results: The proposed framework results are advantageous to all stakeholders ensuring transparency, data integrity, and protocol compliance. Although the proposed solution is tested on the Ethereum blockchain platform, it can be deployed in private blockchain networks using their native smart contract technologies. We make our smart contract code publicly available on Github. Conclusions: We conclude that the proposed framework can be highly effective in ensuring that the trial abides by the protocol and the functions are executed only by the stakeholders who are given permission. It also assures data integrity and promotes transparency and traceability of information among stakeholders.

Is blockchain ready for orthopaedics? A systematic review

“…Summarising the key characteristics of the 10 articles reporting blockchain solutions operating in a live or "real world" context. 9e12, 19,21,23,25,32,50 Fig. 2.…”

“…Six of these studies used smart contract technology as a central aspect of the data management process. In a typical example, Omar et al 24 utilise smart contracts, to develop a system in which decisions about data handling are removed from the conventional centralised institutional model and distributed between multiple different institutions, each with guaranteed access rights. This prevents data hoarding, promotes transparency, and allows each institution to monitor the data usage of other collaborators.…”

“…31 Blockchain technology may also be able to promote transparent research processes. For example, Omar et al 32 show how an Ethereum-based research platform can be used to upload and timestamp a number of prospectively described research conditions onto a blockchain using the Interplanetary File System (IPFS). Study aims, inclusion criteria, and proposed statistical methods are effectively "locked in" prior to the commencement of the study.…”

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“…Similar advantages have been reported with the conduct (eg, protocol compliance) and analysis of clinical trials, as well as omics big data. [49][50][51] Furthermore, blockchain promotes the automation of consent-giving and may give rise to prosent, or 'the blockchain-enabled ability of all stakeholders in the research process to pseudonymously and proactively consent to data release or exchange under specific conditions, such as trial completion.' 52 The manipulation of data and growing distrust of contemporary science has taken a central role in this pandemic, especially centred around hydroxychloroquine use and the associated Surgisphere scandal whereby data, published in two of the world's leading medical journals, turned out to be fraudulent.…”

Leveraging Blockchain Technology for Informed Consent Process and Patient Engagement in a Clinical Trial Pilot

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