临床创新:数字健康解决方案如何改变澳门葡京赌博游戏的试验

出版
2023年9月26日


写的:

克里斯蒂娜•杜兰

首席数字健康官R&D、澳门葡京网赌游戏 

马修Bonam

副总裁数字健康,澳门葡京赌博游戏R&D、澳门葡京网赌游戏

The rapid and continued evolution of digital technology has enabled new digital healthcare solutions for clinical trials; this has the potential to transform clinical study design, 患者和试验现场团队的经验, 改善临床结果, 减少参与者的时间和负担,提高环境的可持续性. 从耐心的洞察开始, 结合不同的技术进行远程数据收集和利用连接的设备, we are enabling new endpoints and ways of collecting data and are making it easier for patients and investigators to participate in our trials.1


为什么澳门葡京赌博游戏需要在临床试验中嵌入数字健康解决方案?

临床试验是提供 新一代疗法. 然而, 医疗保健环境正变得越来越复杂, 给临床研究带来新的挑战, 包括患者招募, 留存率和多样性. There was an upsurge in the application of 数字健康解决方案 in delivery of healthcare during the COVID-19 pandemic, 哪些因素催化和加速了临床试验招募和参与的变化.  

These changes were well aligned with our focus on digital patient and site solutions; we are now leveraging these approaches to ensure that our trials are designed and delivered with patients and site teams at the centre, with the aim to support health equity and inclusion and to deliver better outcomes faster and in an environmentally sustainable way. 一旦病人参加了试验, 数字健康解决方案 have the potential to make participation considerably less burdensome – for both patients and trial teams.


澳门葡京赌博游戏如何为临床试验设计反映患者需求的数字健康解决方案?

更好地了解参与临床试验的经验, 澳门葡京赌博游戏对300多名患者进行了定性研究, 护理人员, 以及来自9个国家的调查人员.1 这些见解使澳门葡京赌博游戏能够确定14个对澳门葡京赌博游戏的病人“重要的时刻”, including multiple opportunities to improve the patient experience across our clinical trial processes by incorporating digital-based solutions into the trial design. 澳门葡京赌博游戏还开发了定制工具,如Merlin, which can provide an automatic score to estimate the likely patient experience index for the study – based on the study design and feedback from patients on the burden of visits and procedures within the study.

澳门葡京赌博游戏可以用这个指数来比较新的研究设计和以前类似的研究, in order to improve the patient experience; moreover, 该分数还可以提供有关成本的信息, 时间表和温室气体排放. 当澳门葡京赌博游戏改善病人的体验, 这可以改善这些领域的结果——与加速的时间表相关, 成本更低,温室气体排放更少.

We also evaluate patients’ experiences in our trials through measures such as our 罕见的疾病 Patient Friction Co-efficient measure. 通过整合这些不同的见解和工具, 澳门葡京赌博游戏可以设计出真正以患者为中心的数字健康解决方案.




数字医疗解决方案、人工智能工具和远程数据收集如何推动澳门葡京赌博游戏试验中的创新

在未来, many of the 评估 currently collected during in-person clinical trial visits to a medical institution could be collected from patients at home using digital technologies. 传统上, 临床试验采用一种基于现场的模式,即“现场”患者亲自访问进行招募, 干预措施, 评估, 和后续的. 这对许多患者来说是一个重大负担, 比如花时间旅行和在诊所等待, 同时还要支付交通费、停车费或请假费. 澳门葡京赌博游戏回顾了肿瘤学研究的91个临床试验方案, 呼吸, and cardiovascular disease and concluded that 74–85% of trial 评估 could be successfully collected remotely using clinically validated devices; this could reduce the number of physical visits to the clinic by up to 40%.1 为了减轻这些负担, 澳门葡京赌博游戏正在开发一系列数字健康解决方案, AI tools 远程数据收集 technologies – informed by our research into patient needs and preferences. 

其中一个解决方案是 统一 – our bespoke digital platform developed for patients and clinical trial teams to support trial participation, 患者可及性(e).g. 通过在家进行虚拟咨询), 远程数据收集, 监控和管理事件. 

例如, clinical trials in patients with chronic obstructive pulmonary disease (COPD) traditionally require that patients’ lung function is measured by a breathing test called spirometry in research clinics. 使用统一,澳门葡京赌博游戏可以使家庭的肺活量监测达到与诊所相同的质量. The use of digital tools in one of our trials in COPD is predicted to reduce treatment duration and the number of in-person visits by 50%, 并导致整个试验时间减少15%, 成本降低32%, 患者体验指数也有望提高68%.1  

澳门葡京赌博游戏还开发了 阿伊达 (自动识别及侦测裁定), 可以支持自动检测的人工智能解决方案, 心血管试验中关键结局事件的报告和评估. 阿伊达 supports us in the identification of cardiovascular events much more rapidly than would traditionally be the case when waiting for patients or their family to report events to the investigators; 阿伊达 also supports the clinical site teams in collating and curating the relevant reports and providing adjudication of events. 

类似的, 澳门葡京赌博游戏目前正在几个肿瘤学试验中探索不同的数字健康解决方案, 包括招聘, 同意, 评估结果, and remote monitoring of symptoms – to support patients and their physicians in the management of those symptoms and with ongoing treatment.



建立数据基础设施,在澳门葡京赌博游戏的试验中实现数字创新

All these new 数字健康解决方案 result in a significant increase in the amount and diversity of data generated in our clinical trials – such as data from imaging, 设备(如肺活量计), 或基因组学. 因此,澳门葡京赌博游戏正在投资于数据基础设施和系统,以帮助澳门葡京赌博游戏改进收集方式, 分析和利用澳门葡京赌博游戏在试验中收集的信息. 

例如, we are increasingly standardising our approaches and the templates for our clinical trial data; these innovations in data collection and analysis help us better manage the extensive data flow in our trials. Our improved data engines also help us lock our clinical trial databases faster once a trial is completed, 加快向监管机构提交试验数据的时间. 


澳门葡京赌博游戏在临床试验中的数字健康解决方案的雄心

澳门葡京赌博游戏的方法 to digital health in clinical trials means more than just introducing new 数字健康解决方案 such as apps or sensors alone – it is about combining these tools in a seamless manner with different ways of working with patients and investigators to design and deliver clinical trials that better support everyone involved. 

澳门葡京赌博游戏的使命 临床创新 at AstraZeneca is to design and deliver patient-centric clinical trials that improve the patient and site team experience, 使用数据, digital and AI to gain earlier insights and improve patient outcomes – all to help us deliver the next generation of life-changing medicines for patients faster than ever before.


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参考:

1. 杜兰有限公司, Bonam米, 比约克E, 休斯R, Ghiorghiu年代, Massacesi C, 坎贝尔一, 哈钦森E, 潘加洛斯MN, 加尔布雷斯年代. 数字医疗技术在临床试验中的实施:6R框架. 自然医学2023.http://doi.org/10.1038/s41591-023-02489-z.


Veeva ID: Z4-59893
筹备日期:2023年11月