临床创新
What is clinical innovation?
临床试验是提供下一波改变生活的药物的基石. 然而, healthcare environments are becoming increasingly complex, creating new challenges for clinical trial research. 最近, the upsurge in 数字 healthcare has catalysed and accelerated changes in clinical trial recruitment and participation, 进一步增加复杂性. Furthermore, the transition towards next-generation therapeutics 是否有必要改变临床试验的设计和交付. To meet these demands for clinical innovation, we are pioneering new approaches to how we engage with patients, trial teams and healthcare providers, 在诊所和其他地方.
临床创新 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, 以及澳门葡京赌博游戏如何使用数据, 数字 和人工智能 to improve patient outcomes and health equity.
Clinical trial transparency
澳门葡京赌博游戏长期致力于公开澳门葡京赌博游戏的临床研究信息. 澳门葡京赌博游戏相信对澳门葡京赌博游戏的研发保持透明, including our clinical trials, is serving the best interests of patients, 他们的亲戚, 护理人员, 医疗专业人员, researchers and the public.
澳门葡京赌博游戏的目标 临床试验网站 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
We have the opportunity to integrate 数字健康解决方案 通过临床试验，帮助患者获得更好的健康结果. 数字医疗 technologies have the potential to enable a broader group of people to participate and reduce patients’ need to travel to the clinic.
数字技术也使澳门葡京赌博游戏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. By leveraging 数字 technology, 澳门葡京赌博游戏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.
探索在澳门葡京赌博游戏的临床试验中创新使用数据和数字技术的例子
改善经验
We developed Unify, a clinical trial support tool. 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.
Co-developed with patients and 医疗专业人员, Unify is designed to enhance the participant experience before, during and after a trial; this includes simplifying and optimising several components of clinical trials, such as virtual consultations, medication reminders and patient-reported outcomes.
优化招生
报名参加试验时, it is important to include diverse groups of patients that represent the broader population of the focus disease area.
To help inform of our approach to enrolment, we have partnered with Tempus, a technology company leading in AI and precision medicine. 这使澳门葡京赌博游戏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. 澳门葡京赌博游戏还为患者提供研究定位器，帮助他们找到合适的试验.
筛选和检测
创新的筛查和检测方法使早期诊断成为可能, giving a higher chance of 治疗 success.
In 肿瘤学, novel biomarkers increasingly guide patient selection. 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, 治疗, and monitoring for recurrence, faster than traditional methods.
澳门葡京赌博游戏与GRAIL合作, a biotechnology company in early cancer screening, to adopt ctDNA biomarkers in more trials and identify high-risk patients with early-stage disease who could benefit most from our medicines.
评估结果事件
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. This can take up to five months.
To accelerate drug development, 澳门葡京赌博游戏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. 如果“不确定”, AIDA escalates to a human; in future, this could shorten timelines of studies significantly.
远程病人监护
通知未来的R&D
征得患者同意, our research teams can utilise data and human biological samples (HBS) collected during trials to help inform the next wave of drug discovery, novel target identification and research and development. 数据与HBS的再利用和结合，使澳门葡京赌博游戏能够更好地设计药物开发战略和计划, 以可持续的方式. This can help us design smarter clinical trials, strengthen our scientific discoveries, 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 数字 health to improve human health and transform patient outcomes is starting to be realised. We are at the forefront of this healthcare revolution, powered by scientific evidence, 数字, longitudinal multiomics health data, 和人工智能.
Designing and delivering patient-centric clinical trials
Clinical trials are necessary to drive innovation, 然而，只有一小部分符合条件的患者选择或能够参加试验. To enable more patients to participate, we are focusing on making them more accessible, providing simpler information and designing our trials so they are easier and more flexible for patients to fit around their routine care.
Learning from the patient experience
澳门葡京赌博游戏与患者和护理人员合作，让他们的声音进入澳门葡京赌博游戏的试验. For patients with rare diseases, Alexion’s 罕见的疾病 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, we have surveyed more than 1,400 patients about the burdens they face during clinical trials. 在设计新的研究时, 澳门葡京赌博游戏用梅林, a tool that proactively calculates a score to help our study teams evaluate how burdensome a trial might be for patients. 基于这些数据, 澳门葡京赌博游戏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.
Designing patient-centric trial endpoints
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 治疗 being studied is beneficial. For several of our asthma and COPD clinical trials, 澳门葡京赌博游戏已经开发了新的复合终点，帮助澳门葡京赌博游戏减少临床试验的规模和持续时间. 此外, 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.
Delivering patient-centred and innovative clinical trial designs
在可能的情况下, 澳门葡京赌博游戏正在引入创新的临床试验设计，可以减轻患者的负担, accelerate timelines and increase efficiency.
We are increasingly utilising platform studies for our early clinical trials that compare multiple potential drugs for a single disease. 例如, 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. Depending on the response to the initial 治疗, 然后，患者可能会在平台试验中切换到其他药物, as indicated by their disease biomarkers.
为社会和地球的健康提供可持续的临床试验
Improving inclusion and diversity in our clinical trials
Prioritising diversity in our clinical trials is key to meeting the needs of our patients and of regulators – it is also simply ‘good science’
Reducing the environmental impact of our trials
We focus on running our trials sustainably, to reduce greenhouse gas emissions and environmental impact, helping create a healthy future for society and the planet. We are using a multitude of operational and 数字健康解决方案 throughout the clinical trial process – from study design to data analysis. 澳门葡京赌博游戏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.
Who could benefit from innovation in clinical trials?
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. 这些包括:
病人
增加了获得临床试验的机会，减少了繁琐的临床试验经验
护理人员
Less burdensome clinical trial experience
网站团队
更多的 streamlined processes to increase efficiency
卫生保健专业人员
Better patient connections enabling enhanced insights
研究人员
Faster access to robust and actionable data
监管机构
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.
Latest updates in clinical innovation
结果
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Veeva ID: Z4-56718
Date of preparation: July 2023