Medidata Sensors

在评估患者健康状况时,临床试验不能仅依赖门诊随访的“瞬时快照”。

Medidata Sensors 实现了连续的医疗级数据采集,将客观的数字指标与 eCOA 相结合,从而长期、动态地全面了解患者的主观感受、身体功能及对治疗的反应,且不会增加患者的参试负担。

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从连续数据到“终点就绪”的临床证据

连续数据只有转化为真正的“临床证据”而非单纯的“数据信号”,才能产生真正的价值。Medidata Sensors 在同一研究中将客观数字指标与主观 eCOA 相结合,并在研究推进过程中,利用经验证的算法持续生成证据。这种方法支持数字终点的应用,从而提升试验期间评估的置信度。

丰富科学证据的生成
客观数据与患者报告数据对齐
及早发现潜在问题
跨研究团队共享统一的临床背景信息
低代码/无代码环境的传感器研究配置
试验级传感器集成

Medidata Sensors 支持范围

Medidata Sensors 支持在受监管的临床试验中,对广泛的生理与功能指标进行连续或间歇性采集。

生命体征

心脏

呼吸

代谢

睡眠

打鼾

抓挠

咳嗽

皮肤电活动

跌倒

运动

活动性

不自主运动

上肢活动性

身体机能

获 FDA 许可

支持510(k) 传感器

85+

经验证的测量方法

间歇性+连续性的

数据采集

试验级

传感器集成

证据策略的临床实践

Sponsors

终点评估的置信度提升研究终点的

告别对终点决策的盲目推测。将客观数字指标与患者的主观报告有机结合,并在研究推进过程中,利用经验证的算法生成更丰富的临床证据。

及早洞察具有临床意义的变化,有效规避试验后期的突发风险,从而在试验期间更具置信度地评估数字终点。

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居家六分钟步行试验

医疗级传感器如何支持居家功能测试,以生成试验就绪的试验与活动数据。
通过真实案例,发现医疗级传感器如何助力居家功能状态评估,并同步生成试验就绪的心脏与运动数据。

Video transcript: Our mission in SensorCloud is to be able to monitor patients in the comfort of their own home. In pulmonary hypertension, the six minute walk test is a extremely important component of the risk assessment. If your heart is not working, your motor's not working, you're not going to go as far. In this standard assessment, you're leaving a lot of information on the table that can easily be collected by putting a sensor on. It became clear that this type of technology could measure some of those motion variables. And we came up with the digital biomarker, which we call cardiac effort. The number of heartbeats used during the six minute walk divided by the walk distance. Bringing together cardiac and motion really enables us to understand physiology. And so by incorporating heart rate, we're really able to see was there a change in their physiology that goes along with the change in their walk distance. When we found a lot of success looking at measurements from the cardiac signal, we started to bring this type of assessment into the home. Patients were excited to do it. They feel like doing this is a part of their care. I can send a patient home with a small device with a very simple set of instructions. One of the nice things about this study is the patient interface with the app. The phone has all the instructions for how to do the assessment and tips on how to set up their course. It really is as simple as just putting the heart rate device on, opening the app, and just following the prompts. Having the power of metadata will allow us to really analyze our ongoing study data. We have proprietary algorithms, and we understand biomechanics really well. Now you can have multiple home checks to really see how patients are changing and responding to drugs. This work is very important, not only to medicine, but to the whole digital health industry.
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常见问题解答

是的。平台提供统一的体验,支持在采集主观 eCOA 数据的同时,同步收集客观传感器数据。临床医生与研究管理者可通过对这些整合数据集的高级分析,构建完整的患者视图,并洞察具有临床意义的趋势。

Medidata Sensors 支持 85+ 项经验证的测量方法,涵盖间歇与连续性传感器。该解决方案针对特定治疗领域采用获 FDA 510(k) 许可的传感器,并具备经严格测试的集成能力与安全数据流。

该解决方案支持被动与居家数据采集,依托直观易用的 myMedidata 移动端 App,为患者提供无感化的传感器数据采集方式。该平台同样支持复杂的评估,如六分钟步行试验,患者在家即可完成,无需再前往研究中心进行访视。

不复杂。Medidata Sensors 采用 Medidata Designer,支持通过低代码/无代码方式进行传感器试验配置。这种精简的配置模式提供清晰的传感器操作指南与患者管理数据看板,让申办方无需应对繁琐的运营事务,即可轻松释放传感器数据的价值。

是的。Medidata 为客户及合作伙伴提供多种培训方案,包括自学课程与讲师授课课程。如需查看可用课程并获取相关资源,请访问 Medidata 全球教育与培训中心。

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