写的:
首席数字健康官R&D、澳门葡京网赌游戏
VP Digital Health, 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, the experience of patients and trial site teams, 改善临床结果, reduce timelines and burden for participants and improve environmental sustainability. 从耐心的洞察开始, combining different technologies for remote data collection and utilising connected devices, 澳门葡京赌博游戏正在启用新的终点和收集数据的方法，并使患者和研究人员更容易参与澳门葡京赌博游戏的试验.1
Why do we need to embed 数字健康解决方案 in clinical trials?
Clinical trials are the cornerstone for delivering the 新一代疗法. 然而, healthcare environments are becoming increasingly complex, leading to new challenges for clinical research, 包括患者招募, 留存率和多样性. 在2019冠状病毒病大流行期间，数字卫生解决方案在医疗保健服务中的应用激增, which catalysed and accelerated changes in clinical trial recruitment and participation.
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, 旨在支持卫生公平和包容，并以环境可持续的方式更快地取得更好的成果. Once patients are enrolled in a trial, 数字健康解决方案 是否有可能大大减轻患者和试验团队的参与负担.
How do we design 数字健康解决方案 for clinical trials that reflect patient needs?
To better understand the experience of participating in clinical trials, we conducted qualitative research with over 300 patients, 护理人员, and trial investigators from nine countries.1 These insights allowed us to identify the 14 ‘moments that matter’ to our patients, 包括通过将基于数字的解决方案纳入试验设计，在临床试验过程中改善患者体验的多个机会. 澳门葡京赌博游戏还开发了 bespoke tools such as Merlin, 根据研究设计和患者对研究中就诊负担和程序的反馈，哪一种方法可以提供一个自动评分来估计该研究可能的患者体验指数.
We can use this index to compare new study designs with those of similar previous studies, in order to improve the patient experience; moreover, the score can also provide information on the costings, timelines and greenhouse gas emissions. When we improve the patient experience, this can improve outcomes across these areas – correlating with accelerated timelines, lower costs and lower greenhouse gas emissions.
澳门葡京赌博游戏还通过诸如罕见病患者摩擦系数等措施来评估患者在试验中的体验. By integrating these different insights and tools, we can design 数字健康解决方案 that are truly patient-centric.
How 数字健康解决方案, AI tools 远程数据收集 drive innovation in our trials
在未来, 目前在医疗机构的亲自临床试验访问期间收集的许多评估可以使用数字技术从患者家中收集. 传统上, clinical trials follow a site-based model of ‘on-site’ in-person patient visits for recruitment, 干预措施, 评估, 和后续的. This represents a significant burden for many patients, such as spending time travelling and waiting in the clinic, as well as having to pay for transport and parking or taking time off work. We reviewed 91 clinical trial protocols for studies in oncology, 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, we are developing a range of 数字健康解决方案, 人工智能工具和远程数据收集技术-通过澳门葡京赌博游戏对患者需求和偏好的研究提供信息.
其中一个解决方案是 统一 -澳门葡京赌博游戏为患者和临床试验团队开发的定制数字平台，以支持试验参与, 患者可及性(e).g. through virtual consultations at home), 远程数据收集, 监控和管理事件.
例如, 慢性阻塞性肺疾病(COPD)患者的临床试验传统上要求通过一种称为肺量测定法的呼吸测试来测量患者的肺功能. Using 统一, we can enable the monitoring of spirometry at home to the same quality as in the clinic. 在澳门葡京赌博游戏的一项COPD试验中，使用数字工具预计可将治疗时间和亲自就诊次数减少50%, and lead to a 15% reduction in overall trial duration, 成本降低32%, as well as an expected 68% improvement in the patient experience index.1
澳门葡京赌博游戏还开发了 阿伊达 (Automatic Identification Detection Adjudication), an AI solution that can support the automated detection, reporting and assessment of key outcome events in our cardiovascular trials. 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, we are currently exploring different 数字健康解决方案 in several of our oncology trials, 包括招聘, 同意, 评估结果, 以及对症状的远程监控，以支持患者和他们的医生管理这些症状并进行持续治疗.
Building a data infrastructure to enable digital innovation in our trials
所有这些新的数字健康解决方案显著增加了澳门葡京赌博游戏临床试验中产生的数据的数量和多样性，例如来自成像的数据, 设备(如肺活量计), 或基因组学. We are therefore investing in the data infrastructure and systems that help us improve how we gather, analyse and utilise the information collected in our trials.
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. 澳门葡京赌博游戏改进的数据引擎还帮助澳门葡京赌博游戏在临床试验完成后更快地锁定澳门葡京赌博游戏的临床试验数据库, and accelerate submission timelines of our trial data to regulators.
