Ensuring protocol compliance and data transparency in clinical trials using Blockchain smart contracts
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(2020) 20:224
TECHNICAL ADVANCE
Open Access
Ensuring protocol compliance and data transparency in clinical trials using Blockchain smart contracts Ilhaam A. Omar1, Raja Jayaraman1, Khaled Salah2, Mecit Can Emre Simsekler1, Ibrar Yaqoob2* Samer Ellahham3
and
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. Keywords: Blockchain, Clinical trials, Healthcare, Ethereum, Smart contracts, IPFS
Background The rapid advancements in blockchain and its prominent features that enforce transparency, trust, and data integrity have expanded its scope beyond the finance * Correspondence: [email protected] 2 Department of Electrical Engineering and Computer Science, Khalifa University, Abu Dhabi 127788, United Arab Emirates Full list of author information is available at the end of the article
sector [1, 2]. There are mainly two types of blockchain networks, namely, public and private. The former is an open-source network that allows anyone to participate in the network; whereas, the latter places a restriction on who is allowed to enter and participate in the network [3]. The unprecedented potentials of blockchain have e
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