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在乳腺癌临床试验中使用区块链进行数据验证和核查：监管沙盒

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

作者信息

Hirano Tomonobu, Motohashi Tomomitsu, Okumura Kosuke, Takajo Kentaro, Kuroki Taiyo, Ichikawa Daisuke, Matsuoka Yutaka, Ochi Eisuke, Ueno Taro

机构信息

SUSMED Inc, Tokyo, Japan.

Division of Health Care Research, Center for Public Health Sciences, National Cancer Center Japan, Tokyo, Japan.

出版信息

J Med Internet Res. 2020 Jun 2;22(6):e18938. doi: 10.2196/18938.

DOI:10.2196/18938
PMID:32340974
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7298640/
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.

摘要

背景

临床试验中数据的完整性至关重要，但当前的数据管理流程过于复杂且劳动强度大。因此，临床试验容易耗费大量预算和时间，并且存在人为错误和数据造假的风险。区块链技术有潜力应对其中一些挑战。

目的

本研究的目的是验证一个使用区块链技术保障临床试验中医疗数据安全的系统。

方法

我们开发了一个用于临床试验的基于区块链的数据管理系统，并通过一项乳腺癌临床试验对该系统进行了测试。该项目是在日本内阁办公室设立的监管沙盒下进行的，旨在展示使用区块链技术进行临床数据管理。

结果

我们使用验证协议对临床试验中的数据进行了验证，并测试了其对数据篡改的抵御能力。2019年8月23日东京地区发生亚马逊网络服务中断事件期间，临床数据注册实现零停机运行，这也证明了该系统的稳健性。

结论

我们表明，我们的系统可以改善临床试验数据管理，增强对临床研究过程的信任，并减轻监管负担。该系统将通过优化临床试验成本，为医疗保健服务的可持续性做出贡献。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/6c4efff0763c/jmir_v22i6e18938_fig9.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/f2a2f952f662/jmir_v22i6e18938_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/ed8d14bc5a4d/jmir_v22i6e18938_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/07c9ae4760e8/jmir_v22i6e18938_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/6f7d71fa5593/jmir_v22i6e18938_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/77b4bad57ef8/jmir_v22i6e18938_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/f4ea16c98cc3/jmir_v22i6e18938_fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/fb84c943585d/jmir_v22i6e18938_fig7.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/826cff9f55ca/jmir_v22i6e18938_fig8.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/6c4efff0763c/jmir_v22i6e18938_fig9.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/f2a2f952f662/jmir_v22i6e18938_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/ed8d14bc5a4d/jmir_v22i6e18938_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/07c9ae4760e8/jmir_v22i6e18938_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/6f7d71fa5593/jmir_v22i6e18938_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/77b4bad57ef8/jmir_v22i6e18938_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/f4ea16c98cc3/jmir_v22i6e18938_fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/fb84c943585d/jmir_v22i6e18938_fig7.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/826cff9f55ca/jmir_v22i6e18938_fig8.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6889/7298640/6c4efff0763c/jmir_v22i6e18938_fig9.jpg

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