Abstract
The clinical research faces numerous challenges, from patient enrollment to data privacy concerns and regulatory requirements to spiraling costs. Blockchain technology has the potential to overcome these challenges, thus making clinical trials transparent and enhancing public trust in a fair and open process with all stakeholders because of its distinct features such as data immutability and transparency. This paper proposes a permissioned blockchain platform to ensure clinical data transparency and provides secure clinical trial-related solutions. We explore the core functionalities of blockchain applied to clinical trials and illustrate its general principle concretely. These clinical trial operations are automated using the smart contract, which ensures traceability, prevents a posteriori reconstruction, and securely automates the clinical trial. A web-based user interface is also implemented to visualize the data from the blockchain and ease the interaction with the blockchain network. A proof of concept is implemented on Hyperledger Fabric in the case study of clinical management for multiple clinical trials to demonstrate the designed approach's feasibility. Lastly, the experiment results demonstrate the efficiency and usability of the proposed platform.
Highlights
Clinical trials generate a significant amount of clinical research data to approve new drugs, instruments, and medical or surgical treatments on human participants [1]
Blockchain technology has many advantages in security, data protection, and the ability to bridge the disparate system manufacturers, CROs, and study sites. This technology has the benefit of centralization without having all of the data located in one place, making it less vulnerable to external or internal attacks
Few studies focus on a specific implementation approach that guarantees integrity and reliability by using blockchain technology in clinical trials, and there is a lack of practical use cases using blockchain in clinical trials
Summary
Clinical trials generate a significant amount of clinical research data to approve new drugs, instruments, and medical or surgical treatments on human participants [1]. The clinical trial requires collaboration among diverse stakeholders, including regulatory bodies, pharmaceutical companies, clinical sites, and most importantly subjects who participate in the clinical trial [2,3,4]. In this model, data is created from disparate sources (smart devices, clinical trial sites), processed, and analyzed by different organizations in their preferred way and format
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