Securing Clinical Trial Data Using Private Blockchain Technology

Shailesh S. Shetty; K. Pushpalatha

doi:10.48084/etasr.16353

Authors

Shailesh S. Shetty Department of Computer Science and Engineering, Sahyadri College of Engineering and Management, Mangalore, Affiliated to Visvesvaraya Technological University, Belagavi, Karnataka, India
K. Pushpalatha Department of Computer Science and Engineering (Artificial Intelligence and Machine Learning), Sahyadri College of Engineering and Management, Mangalore, Affiliated to Visvesvaraya Technological University, Belagavi, Karnataka, India

Volume: 16 | Issue: 2 | Pages: 34623-34629 | April 2026 | https://doi.org/10.48084/etasr.16353

Received: 18 November 2025 | Revised: 11 December 2025, 6 January 2026, 20 January 2026, and 5 February 2026 | Accepted: 7 February 2026 | Online: 19 March 2026

Corresponding author: Shailesh S. Shetty

Abstract

The COVID-19 pandemic placed unprecedented strain on global healthcare systems and exposed several limitations in managing large-scale public health emergencies. The adoption of emerging technologies, however, such as Blockchain, Artificial Intelligence (AI), and Machine Learning (ML), offers opportunities to develop systems that are better suited to help the healthcare system during such challenges. For instance, Blockchain technology can be utilized to secure patient data, Clinical Trial (CT) records, and other sensitive medical information. Among these applications, CTs represent a critical component of drug development and are also one of its most costly and complex stages. Nonetheless, implementing a Blockchain-based CT management system can enhance data traceability, reduce operational costs, and enable efficient record management, assisting regulatory bodies in reviewing and approving drugs more rapidly, enabling faster release of new treatments to the market, and potentially saving lives. Therefore, this study proposes a permissioned private Blockchain-based architecture utilizing Hyperledger Fabric, along with smart contracts within the Hyperledger network, which facilitates secure, transparent, and efficient coordination among all CT stakeholders while maintaining data privacy through controlled access and the use of independent ledgers. Performance analysis of the proposed system, evaluated in terms of throughput, latency, and execution time, indicates that private Blockchain systems demonstrate superior performance relative to public Blockchain implementations.

Keywords:

Blockchain technology, clinical trials, consent, healthcare, participants, private Blockchain

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