在临床试验中应用数字技术:经验教训。

Q3 Medicine Innovations in clinical neuroscience Pub Date : 2022-04-01
Georgia Mitsi, Todd Grinnell, Suzanne Giordano, Thomas Goodin, Shahin Sanjar, Elizabeth Marble, Andrei Pikalov
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引用次数: 0

摘要

我们在临床开发项目中对多种数字健康技术进行了评估,包括外置、可穿戴、可植入和可摄取的设备和传感器,以及可通过用户个人电子设备(如智能手机、平板电脑和电脑)访问的数字移动健康应用程序(App)。其中几项技术已被纳入我们正在进行的神经和呼吸临床开发项目。根据我们的经验,数字健康技术最大的潜在优势之一是能够在患者正常的日常活动中持续或定期收集诊室外的客观和/或生物数据,以提供额外的疗效和安全性信息,而不是从传统的基于时间点的偶发诊室访问中获取数据。通过为员工和患者提供适当的培训,确保提供适当的基础设施支持,以及在扩大规模进行更大规模试验之前开展试点研究,可以成功应对数字医疗技术遇到的许多挑战。总之,我们在数字医疗技术方面的经验表明,它们有潜力增加临床试验中收集的客观数据量,扩大患者参与试验的机会,并促进临床结果的进一步改善。
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Implementing Digital Technologies in Clinical Trials: Lessons Learned.

Multiple digital health technologies have been evaluated across clinical development programs, including external, wearable, implantable, and ingestible devices and sensors, along with digital mobile health applications (apps) that are accessible via users' personal electronic devices (e.g., smartphones, tablets, and computers). Several of these technologies have been incorporated into our ongoing neurology and respiratory clinical development programs. Based on our experience, one of the greatest potential benefits of digital health technologies is the ability to collect objective and/or biological data continuously or at regular intervals outside of office visits during a patient's normal daily activities to provide additional efficacy and safety information, versus data capture from traditional episodic, time point-based office visits. Many challenges encountered with digital health technologies can be successfully addressed by providing the appropriate training to staff and patients, ensuring availability of appropriate infrastructure support, and conducting pilot studies before scaling up to larger trials. Overall, our experience with digital health technologies demonstrated their potential to increase the amount of objective data collected in clinical trials, expand patient access to trials, and facilitate further improvement of clinical outcomes.

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来源期刊
Innovations in clinical neuroscience
Innovations in clinical neuroscience Medicine-Psychiatry and Mental Health
CiteScore
2.10
自引率
0.00%
发文量
87
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