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Towards an Architecture to Guarantee Both Data Privacy and Utility in the First Phases of Digital Clinical Trials

机译:致力于在数字临床试验的第一阶段确保数据隐私和实用性的体系结构

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摘要

In the era of the Internet of Things (IoT), drug developers can potentially access a wealth of real-world, participant-generated data that enable better insights and streamlined clinical trial processes. Protection of confidential data is of primary interest when it comes to health data, as medical condition influences daily, professional, and social life. Current approaches in digital trials entail that private user data are provisioned to the trial investigator that is considered a trusted party. The aim of this paper is to present the technical requirements and the research challenges to secure the flow and control of personal data and to protect the interests of all the involved parties during the first phases of a clinical trial, namely the characterization of the potential patients and their possible recruitment. The proposed architecture will let the individuals keep their data private during these phases while providing a useful sketch of their data to the investigator. Proof-of-concept implementations are evaluated in terms of performances achieved in real-world environments.
机译:在物联网(IoT)时代,药物开发人员可以潜在地访问大量由参与者生成的真实世界的数据,从而提供更好的见解和简化的临床试验流程。当涉及健康数据时,保护机密数据是最重要的,因为医疗状况会影响日常,职业和社交生活。数字试验中的当前方法需要将私人用户数据提供给被认为是可信方的试验研究者。本文的目的是提出技术要求和研究挑战,以确保在临床试验的第一阶段(即对潜在患者的表征)中个人数据的流动和控制以及保护所有相关方的利益。及其可能的招募。拟议的体系结构将使个人在这些阶段保持数据私密,同时向调查人员提供有用的数据草图。根据在现实环境中获得的性能评估概念验证的实现。

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