Improving Clinical Trial Data Management using Blockchain Technology

  • Ilhaam Omar

    Student thesis: Master's Thesis


    Clinical trials (CTs) play a crucial role in testing and validating the safety and efficacy of newly discovered drugs on specific patient population cohorts. These trials usually experience many challenges, such as extensive time frames, high financial cost, regulatory and administrative barriers, insufficient workforce, etc. Furthermore, CTs face several data management challenges pertaining to protocol compliance, patient enrollment, transparency, traceability, data integrity, selective reporting, etc. Blockchain Technology (BCT) can potentially address such challenges due to its intrinsic features and properties. Although existing literature broadly discusses the applicability of blockchain-based solutions for CTs, only a few papers present a working proof of the concept. In this paper, we propose a blockchain-based framework for CT data management that exploits Ethereum smart contracts and Interplanetary File System (IPFS) technologies. The proposed framework captures various stakeholder interactions in CT more efficiently. We also present algorithms that capture various stages of CT data management. We develop an Ethereum smart contract using Remix IDE validated under different scenarios. The proposed framework and results are advantageous to all stakeholders ensuring transparency, data integrity and protocol compliance. Our proposed framework is generic enough and is applicable to single and multi-site settings.
    Date of AwardDec 2019
    Original languageAmerican English


    • Blockchain Technology
    • Clinical Trial Management system
    • Data integrity
    • Data provenance
    • Ethereum
    • Patient Enrollment
    • Smart Contract
    • Healthcare
    • Transparency.

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