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

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 barrie...

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Vydáno v:BMC medical research methodology Ročník 20; číslo 1; s. 224 - 17
Hlavní autoři: Omar, Ilhaam A., Jayaraman, Raja, Salah, Khaled, Simsekler, Mecit Can Emre, Yaqoob, Ibrar, Ellahham, Samer
Médium: Journal Article
Jazyk:angličtina
Vydáno: London BioMed Central 07.09.2020
BioMed Central Ltd
Springer Nature B.V
BMC
Témata:
Algorithms
Analysis
Blockchain
Blockchains (Databases)
Clinical trials
Computerized physician order entry
Consent
Data collection
Data integrity
Disclosure of information
Ethereum
Health Sciences
Healthcare
Information sharing
IPFS
Medical protocols
Medicine
Medicine & Public Health
Patients
Privacy
quality
Regulatory approval
reporting
Smart contracts
Software
Statistical Theory and Methods
Statistics for Life Sciences
Technical Advance
Theory of Medicine/Bioethics
United Arab Emirates
Clinical trials
Healthcare
Smart contracts
IPFS
Blockchain
Ethereum
ISSN:1471-2288, 1471-2288
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Shrnutí: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.
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ISSN:1471-2288
1471-2288
DOI:10.1186/s12874-020-01109-5