Abstract
BackgroundThe 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.ObjectiveThe aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology.MethodsWe 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.ResultsWe 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.ConclusionsWe 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.
Highlights
Clinical trials involve a large flow of medical information, and it is necessary to secure the transparency and traceability of clinical data
The robustness of the system was 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
We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden
Summary
Clinical trials involve a large flow of medical information, and it is necessary to secure the transparency and traceability of clinical data. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use–Good Clinical Practice (ICH-GCP) provides guidance for monitoring the conduct of a clinical trial to verify that reported clinical data are complete, accurate, and accounted for by source records. The long-standing practice in the pharmaceutical and medical device industries has been frequent site visits and 100% source data verification (SDV) on site to ensure that data captured in source records are transferred correctly to the case report forms. As the complexity and size of clinical trials grow, it has become increasingly expensive to apply the 100% SDV approach [2,3]. Clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification.
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