The design and development of a blockchainbased epro system for collecting clinical data

Abstract

Objectives: The present study discussed the design and development of an ePRO system that records and manages clinical trial data on a blockchain network so as to prevent any arbitrary modification, forgery, or falsification and improve the reliability of the data. Methods: The overall system design and development of ePRO consists of (1) advancement and development of blockchain technology, (2) development of a blockchain clinical trial system model, (3) development of a clinical trial data collecting tool using blockchain, and (4) technological verification of the blockchain-based ePRO system. Results: The results of this study suggest a potential to save human resources and costs for CDM operation by increasing reliability through the implementation of an on-chain clinical trial system. Additionally, the on-chain clinical trial system is predicted to help prevent harm from serious abnormal reactions, including patients' death, subsequent side effects, and birth defects caused by clinical trial errors. Conclusions: The ePRO system can serve as a platform for medical and clinical services to cope with expanding clinical data fields. When the system developed in this study is combined in the near future with state-of-the-art technologies such as IoT and AI, a new paradigm for clinical data repositories and management systems is predicted to develop. Based on the clinical data collected by this ePRO system, when a clinical data warehouse is established and linked to medical information systems, a servitization model that can accelerate innovation in the medical service market is expected to emerge.