A Private Blockchain Based Approach for Securing Clinical Trials Data to Provide Data Security and Interoperability

Abstract

This research proposes a Blockchain-driven solution for enhancing the integrity and security of clinical trials, introducing a specialized system called Blockchain for Securing Clinical Trials (BC-SCT). The system reimagines traditional clinical trial data management by offering a decentralized, tamper-resistant platform that ensures trust, transparency, and efficiency across stakeholders including researchers, sponsors, and regulatory bodies.BC-SCT employs modern consensus mechanisms such as Proof-of-Authority (PoA) and Delegated Proof of Stake (DPoS) to significantly reduce transaction processing delays—from 900 ms to 550 ms across 50 transactions—ensuring faster data validation without compromising reliability. It also demonstrates strong performance under simultaneous query loads, cutting response times from 70 ms to 40 ms, a 43% improvement in real-time data access. To handle the scale and complexity of clinical data, the system incorporates features like data sharding, in-memory caching, and off-chain storage. These enhancements reduce Blockchain ledger load by 20%, lowering storage requirements from 100 GB to 80 GB for 10,000 entries—while maintaining high-speed access and data fidelity. Through these innovations, BC-SCT offers a future-proof foundation for conducting and overseeing clinical trials, addressing long-standing issues related to data manipulation, inefficiency, and lack of transparency in research workflows.