Clinical innovation
什么是临床创新?
临床试验是提供下一波改变生活的药物的基石. However, 医疗保健环境正变得越来越复杂, 为临床试验研究带来新的挑战. Recently, the upsurge in digital healthcare has catalysed and accelerated changes in clinical trial recruitment and participation, adding further complexity. 此外，向 下一代疗法 是否有必要改变临床试验的设计和交付. 为了满足这些需求，临床创新, 澳门第一赌城在线娱乐正在开拓与患者互动的新方法, 试验团队和医疗保健提供者, in the clinic and beyond.
Clinical innovation means we are constantly thinking about how we can design and deliver patient-centric clinical trials that improve the experience of patients and site teams, and how we can use data, 数字和人工智能，以改善患者的治疗结果和卫生公平.
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临床试验透明度
澳门第一赌城在线娱乐长期致力于公开澳门第一赌城在线娱乐的临床研究信息. 澳门第一赌城在线娱乐相信对澳门第一赌城在线娱乐的研发保持透明, 包括澳门第一赌城在线娱乐的临床试验, 为病人的最大利益服务吗, their relatives, caregivers, healthcare professionals, researchers and the public.
The aim of our clinical trial website is to increase knowledge and awareness of clinical trials including what it means to participate and to increase access to relevant clinical trials for patients.
使用数据和数字健康解决方案来改善体验和患者治疗效果
澳门第一赌城在线娱乐有机会整合 digital health solutions 通过临床试验，帮助患者获得更好的健康结果. Digital health technologies have the potential to enable a broader group of people to participate and reduce patients’ need to travel to the clinic.
数字技术也使澳门第一赌城在线娱乐能够使用病人在家就能使用的设备来收集数据. 这使医疗保健提供者能够实时监测症状和生命体征, giving clinicians and study teams a better understanding of how an investigational medicine impacts a disease and how it interacts with an individual’s overall health and quality of life. 利用数码科技, 澳门第一赌城在线娱乐还减少了为最需要的患者开发改变生活的药物所需的时间.
探索在澳门第一赌城在线娱乐的临床试验中创新使用数据和数字技术的例子
Improving experience
澳门第一赌城在线娱乐开发了临床试验支持工具Unify. Unify aims to reduce the complexity of clinical trials for patients and sites by integrating the clinical trial experience into a single mobile application for patients and a web-based portal for site teams.
与患者和医疗保健专业人员共同开发, Unify旨在增强参与者之前的体验, during and after a trial; this includes simplifying and optimising several components of clinical trials, 比如虚拟咨询, 药物提醒和患者报告的结果.
Optimising enrolment
When enrolling for trials, it is important to include diverse groups of patients that represent the broader population of the focus disease area.
以帮助告知澳门第一赌城在线娱乐的招生方法, 澳门第一赌城在线娱乐和腾普斯合作过, 一家在人工智能和精准医疗领域领先的科技公司. 这使澳门第一赌城在线娱乐能够访问世界上最大的匿名数据库之一, so we can identify and provide sites in the United States with data of consenting oncology patients whose disease profiles match a specific trial – and who could potentially benefit from an experimental medicine. 澳门第一赌城在线娱乐还为患者提供研究定位器，帮助他们找到合适的试验.
Screening and detection
创新的筛查和检测方法使早期诊断成为可能, 使治疗成功的几率更高.
在肿瘤学领域，新的生物标志物越来越多地指导着患者的选择. 这些生物标志物是基于检测循环肿瘤DNA (ctDNA)。, 小的DNA片段从癌细胞中泄漏到血液中，为检测提供了机会, treatment, 监测复发, 比传统方法更快.
We collaborate with GRAIL, 一家从事早期癌症筛查的生物技术公司, to adopt ctDNA biomarkers in more trials and identify high-risk patients with early-stage disease who could benefit most from our medicines.
Assessing outcome events
Clinical trial events like ‘cardiovascular death’ need to be examined by an independent adjudication committee to qualify whether they were caused by a cardiovascular issue or another condition. 这可能需要长达五个月的时间.
加速药物开发, 澳门第一赌城在线娱乐与监管机构合作开发了AIDA(自动识别检测裁决). AIDA使用人工智能和机器学习来评估裁决的确定性, 并证明了与人类专家裁决的高度一致性. If ‘uncertain’, AIDA escalates to a human; in future, 这可以显著缩短研究时间.
Remote patient monitoring
数字疗法是健康和技术的结合，以改善传统药物本身.
These scientifically validated apps and devices – which are often prescribed by a healthcare provider alongside traditional medicine – deliver software-generated therapeutic interventions. 澳门第一赌城在线娱乐目前在澳门第一赌城在线娱乐的治疗领域开发了几种数字治疗方法.
Informing future R&D
With patients’ consent, our research teams can utilise data and human biological samples (HBS) collected during trials to help inform the next wave of drug discovery, 新型靶点的鉴定与研发. 数据与HBS的再利用和结合，使澳门第一赌城在线娱乐能够更好地设计药物开发战略和计划, in a sustainable way. 这可以帮助澳门第一赌城在线娱乐设计更智能的临床试验, 加强科学发现, 并最终有可能帮助患者在正确的时间接受正确的治疗.
The opportunity for digital health to improve human health and transform patient outcomes is starting to be realised. 澳门第一赌城在线娱乐处于这场医疗保健革命的最前沿, 以科学证据为基础, digital, 纵向多组学健康数据, and AI.
设计和提供以患者为中心的临床试验
临床试验是推动创新的必要条件, 然而，只有一小部分符合条件的患者选择或能够参加试验. 让更多的患者参与进来, 澳门第一赌城在线娱乐的重点是让它们更容易获得, providing simpler information and designing our trials so they are easier and more flexible for patients to fit around their routine care.
从病人的经验中学习
澳门第一赌城在线娱乐与患者和护理人员合作，让他们的声音进入澳门第一赌城在线娱乐的试验. 对于患有罕见疾病的患者, Alexion’s Rare Disease Patient Friction Coefficient assesses the burden of clinical trials on patients and their families and allows us to utilise these insights to inform and improve our trial designs and protocols. 在其他疾病领域, 澳门第一赌城在线娱乐调查了1个以上,400名患者讲述了他们在临床试验中面临的负担. 在设计新的研究时, we use Merlin, a tool that proactively calculates a score to help our study teams evaluate how burdensome a trial might be for patients. Based on these data, 澳门第一赌城在线娱乐的研究团队可以做出明智的决定，以减少试验中这些潜在的负担.
设计以患者为中心的试验终点
Designing better trial endpoints is one way to support clinical decision-making and capture the whole disease burden and trial journey of patients. A trial endpoint is an event or outcome that can be objectively measured to determine whether the intervention or treatment being studied is beneficial. 在澳门第一赌城在线娱乐的几个哮喘和慢性阻塞性肺病临床试验中, 澳门第一赌城在线娱乐已经开发了新的复合终点，帮助澳门第一赌城在线娱乐减少临床试验的规模和持续时间. Moreover, we piloted the use of at-home spirometry measurements and virtual coaching to enable the remote collection of data for this endpoint, 将亲自就诊的需求减少50%，并减少患者的旅行需求.
提供以患者为中心的创新临床试验设计
Where possible, 澳门第一赌城在线娱乐正在引入创新的临床试验设计，可以减轻患者的负担, 加快进度，提高效率.
We are increasingly utilising platform studies for our early clinical trials that compare multiple potential drugs for a single disease. For example, patients can be enrolled to a platform study in cardiovascular disease based on results of biomarker tests for different sub-types of their specific disease. 取决于对初始治疗的反应, 然后，患者可能会在平台试验中切换到其他药物, 正如他们的疾病生物标志物所表明的那样.
通过设计以患者为中心的试验, 改善患者体验, 使用数字技术, 澳门第一赌城在线娱乐正在不断扩大澳门第一赌城在线娱乐接触不同患者群体的能力.
为社会和地球的健康提供可持续的临床试验
提高临床试验的包容性和多样性
澳门第一赌城在线娱乐致力于设计公平的临床项目，从想法的开始到病人的护理. 澳门第一赌城在线娱乐的方法包括增加临床试验参与者的多样性, 因此，试验更好地反映了可能使用澳门第一赌城在线娱乐药物的患者, 这能确保澳门第一赌城在线娱乐有有力可靠的证据吗.
Prioritising diversity in our clinical trials is key to meeting the needs of our patients and of regulators – it is also simply ‘good science’
减少试验对环境的影响
澳门第一赌城在线娱乐专注于可持续地运行澳门第一赌城在线娱乐的试验, 减少温室气体排放和对环境的影响, 为社会和地球创造一个健康的未来. We are using a multitude of operational and digital health solutions throughout the clinical trial process – from study design to data analysis. 澳门第一赌城在线娱乐的业务创新包括减少面对面会议和病人的门诊就诊, 通过更好地预测哪里需要实验室试剂盒来减少浪费的数量, 将未使用的工具包转移到其他医疗机构，并减少一次性塑料的使用.
谁能从临床试验的创新中受益?
临床试验创新的好处是显著的，可以对整个生态系统产生积极影响. These include:
Patients
增加了获得临床试验的机会，减少了繁琐的临床试验经验
Caregivers
减少繁琐的临床试验经验
Site teams
更精简的流程以提高效率
Health care professionals
更好的患者连接，增强洞察力
Researchers
更快地访问健壮且可操作的数据
Regulators
缩短时间和试验人群，更好地反映临床实践
Our objective is to run our trials more efficiently and get potential new medicines to patients more quickly – through innovation we’re reducing the time commitment for patients and investigators and improving the trial experience to benefit all involved.
