Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox (Preprint)

Abstract

BACKGROUND The integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges. OBJECTIVE The aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology. METHODS We have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. RESULTS We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. CONCLUSIONS We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials.

Qualitative Study of Participant Impressions as Simulated Patients of MediLinker—A Blockchain-Based Identity Verification Application

“…3 In contrast to a centralized management model in which electronic health data are currently stored, researchers believe blockchain or distributive ledgers in a trusted peer-to-peer network can bridge the gaps between these “data siloes” in health care and provide patients control over their medical data. 3 4 5 6 7 8 9 10 For instance, blockchain technology can be used to store information in decentralized nodes making the patient's identity and medical information within a blockchain verifiable. 3 Such an architecture allows for greater interoperability and security.…”