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用于加强临床试验的生物医学注册框架的设计与虚拟实现:以结直肠癌为例

Design and virtual implementation of a biomedical registry framework for the enhancement of clinical trials: colorectal cancer example.

作者信息

Kotoulas Athanasios, Lambrou George, Koutsouris Dimitrios-Dionysios

机构信息

School of Electrical and Computer Engineering, Biomedical Engineering Laboratory, National Technical University of Athens, Athens, Greece

School of Electrical and Computer Engineering, Biomedical Engineering Laboratory, National Technical University of Athens, Athens, Greece.

出版信息

BMJ Health Care Inform. 2019 May;26(1):1-10. doi: 10.1136/bmjhci-2019-100008.

Abstract

INTRODUCTION

Clinical trials generate a large volume of literature and a vast amount of data. Following the 'open science' model, data sharing has enormous potential to strengthen scientific research. Currently, to the best of our knowledge, there is no existing web based Hellenic biomedical registry that displays available patients for clinical trials, providing direct access to registered physicians to all data, assisting them in finding eligible patients in the initial clinical trial recruitment process.

METHODS

This paper describes the design and virtual implementation of a web based prototype biomedical registry in Greece. The system represents an eGovernment framework proposal for the central storage of patients' biomedical information and the operations associated with this process. The increasing tendency to include molecular data as prerequisite elements in clinical trials is adopted in the registry philosophy. The designed system is based on free, open source software and it is implemented virtually on a local host environment.

RESULTS

Using colorectal cancer as an example, valid data from patients increases the reliability index, demonstrating the functionality of the web application.

CONCLUSION

In conclusion, the combination of biomedical data and information technology in order to display potential participants per health unit, facilitates recruitment for clinical trials.

摘要

引言

临床试验产生了大量的文献和海量的数据。遵循“开放科学”模式,数据共享对于加强科学研究具有巨大潜力。目前,据我们所知,尚无基于网络的希腊生物医学登记处来展示可用于临床试验的患者信息,也无法让注册医生直接获取所有数据,协助他们在初始临床试验招募过程中找到符合条件的患者。

方法

本文描述了希腊一个基于网络的生物医学登记处原型的设计与虚拟实现。该系统代表了一个电子政务框架提案,用于集中存储患者的生物医学信息以及与此过程相关的操作。登记处的理念采用了将分子数据作为临床试验必备要素的日益增长的趋势。所设计的系统基于免费的开源软件,并在本地主机环境中进行虚拟实现。

结果

以结直肠癌为例,患者的有效数据提高了可靠性指标,证明了该网络应用程序的功能。

结论

总之,生物医学数据与信息技术相结合,以便按健康单位展示潜在参与者,有助于临床试验的招募工作。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a82a/7062330/7b3e24e06df7/bmjhci-2019-100008f01.jpg

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