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


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          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.


          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.


          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.


          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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          Most cited references12

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          Blockchain distributed ledger technologies for biomedical and health care applications

          Abstract Objectives To introduce blockchain technologies, including their benefits, pitfalls, and the latest applications, to the biomedical and health care domains. Target Audience Biomedical and health care informatics researchers who would like to learn about blockchain technologies and their applications in the biomedical/health care domains. Scope The covered topics include: (1) introduction to the famous Bitcoin crypto-currency and the underlying blockchain technology; (2) features of blockchain; (3) review of alternative blockchain technologies; (4) emerging nonfinancial distributed ledger technologies and applications; (5) benefits of blockchain for biomedical/health care applications when compared to traditional distributed databases; (6) overview of the latest biomedical/health care applications of blockchain technologies; and (7) discussion of the potential challenges and proposed solutions of adopting blockchain technologies in biomedical/health care domains.
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            Blockchain beyond bitcoin

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              Blockchain for AI: Review and Open Research Challenges


                Author and article information

                BMC Med Res Methodol
                BMC Med Res Methodol
                BMC Medical Research Methodology
                BioMed Central (London )
                7 September 2020
                7 September 2020
                : 20
                : 224
                [1 ]GRID grid.440568.b, ISNI 0000 0004 1762 9729, Department of Industrial & Systems Engineering, , Khalifa University, ; Abu Dhabi, 127788 United Arab Emirates
                [2 ]GRID grid.440568.b, ISNI 0000 0004 1762 9729, Department of Electrical Engineering and Computer Science, , Khalifa University, ; Abu Dhabi, 127788 United Arab Emirates
                [3 ]Heart & Vascular Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates
                Author information
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                : 19 April 2020
                : 30 August 2020
                Funded by: FundRef http://dx.doi.org/10.13039/501100004070, Khalifa University of Science, Technology and Research;
                Award ID: CIRA-2019-001.
                Award Recipient :
                Technical Advance
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                © The Author(s) 2020

                blockchain,clinical trials,healthcare,ethereum,smart contracts,ipfs
                blockchain, clinical trials, healthcare, ethereum, smart contracts, ipfs


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