临床创新
What is clinical innovation?
Clinical trials are the cornerstone of delivering the next wave of life-changing medicines. 然而, healthcare environments are becoming increasingly complex, creating new challenges for clinical trial research. 最近, 数字医疗保健的兴起催化并加速了临床试验招募和参与方面的变化, 进一步增加复杂性. Furthermore, the transition towards next-generation therapeutics is necessitating changes to the design and delivery of clinical trials. 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.
Clinical trial transparency
We have a long-standing commitment to make information about our clinical research publicly available. We believe that being transparent about our research and development, 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, 研究人员和公众.
澳门葡京赌博游戏的目标 临床试验网站 是提高临床试验的知识和意识，包括参与临床试验的意义，以及增加患者获得相关临床试验的机会.
Using data and 数字健康解决方案 to improve experience and patient outcomes
We have the opportunity to integrate 数字健康解决方案 across clinical trials and help patients achieve better health outcomes. 数字卫生技术有可能使更广泛的人群参与其中，并减少患者前往诊所的需要.
Digital technologies are also allowing us to collect data using devices patients can use at home. This enables healthcare providers to monitor symptoms and vital signs in real-time, 让临床医生和研究团队更好地了解研究药物如何影响疾病，以及它如何与个人的整体健康和生活质量相互作用. By leveraging 数字 technology, we are also reducing the time needed to develop life-changing medicines for patients who need them most.
Explore examples of innovative use of data and 数字 technology in our clinical trials
改善经验
We developed Unify, a clinical trial support tool. Unify旨在通过将临床试验经验集成到一个针对患者的移动应用程序和一个针对站点团队的基于web的门户中，从而降低患者和站点的临床试验的复杂性.
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, 重要的是纳入不同的患者群体，代表焦点疾病领域的更广泛人群.
To help inform of our approach to enrolment, we have partnered with Tempus, a technology company leading in AI and precision medicine. This gives us access to one of the world’s largest libraries of anonymised data, 因此，澳门葡京赌博游戏可以确定并向美国的站点提供同意的肿瘤患者的数据，这些患者的疾病特征与特定的试验相匹配，并且可能从实验药物中受益. We also support patients with study locators to help them find suitable trials.
筛选和检测
Innovative screening and detection methods are enabling earlier diagnosis, giving a higher chance of 治疗 success.
In 肿瘤学, novel biomarkers increasingly guide patient selection. These biomarkers are based on detecting circulating tumour DNA (ctDNA), small DNA fragments leaking from cancer cells into the bloodstream – unlocking opportunities for detection, 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, 在更多的试验中采用ctDNA生物标志物，并确定可能从澳门葡京赌博游戏的药物中获益最多的早期疾病高危患者.
评估结果事件
像“心血管死亡”这样的临床试验事件需要由一个独立的裁决委员会进行审查，以确定它们是由心血管问题还是其他疾病引起的. This can take up to five months.
To accelerate drug development, we worked with regulators to develop AIDA (Automating Identification Detection Adjudication). AIDA uses AI and machine learning to assess the certainty of the adjudication, and has demonstrated a high degree of consistency with human expert adjudication. 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
Digital therapeutics are where health and technology merge to improve on traditional medicines alone.
这些经过科学验证的应用程序和设备——通常由医疗保健提供者与传统药物一起开处方——提供软件生成的治疗干预措施. We currently have several 数字 therapeutics in development across our therapy areas.
通知未来的R&D
征得患者同意, 澳门葡京赌博游戏的研究团队可以利用试验期间收集的数据和人类生物样本(HBS)来帮助告知下一波药物发现, novel target identification and research and development. Reusing and combining data and HBS enables better design of our drug development strategies and programmes, 以可持续的方式. This can help us design smarter clinical trials, strengthen our scientific discoveries, and ultimately has the potential to help patients receive the right 治疗s at the right time.
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, yet only a small percentage of eligible patients choose or are able to join a trial. To enable more patients to participate, we are focusing on making them more accessible, 提供更简单的信息，设计澳门葡京赌博游戏的试验，使他们更容易，更灵活地适应患者的日常护理.
Learning from the patient experience
We work with patients and 护理人员 as partners to bring their voice into our trials. For patients with rare diseases, Alexion的罕见病患者摩擦系数评估临床试验对患者及其家属的负担，并允许澳门葡京赌博游戏利用这些见解来告知和改进澳门葡京赌博游戏的试验设计和方案. Across other disease areas, 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, 这是一种主动计算分数的工具，可以帮助澳门葡京赌博游戏的研究团队评估一项试验对患者的负担有多重. 基于这些数据, our research teams can make informed decisions to reduce these potentially burdensome aspects of a trial.
Designing patient-centric trial endpoints
设计更好的试验终点是支持临床决策和捕捉患者整个疾病负担和试验过程的一种方法. 试验终点是可以客观测量的事件或结果，以确定所研究的干预或治疗是否有益. For several of our asthma and COPD clinical trials, we have developed novel composite endpoints that help us to reduce the size and duration of our clinical trials. 此外, 澳门葡京赌博游戏尝试使用家庭肺活量测量和虚拟指导来远程收集该终点的数据, reducing the need for in-person visits by 50% and the need for patients to travel.
Delivering patient-centred and innovative clinical trial designs
在可能的情况下, we are introducing the innovative clinical trial designs that could reduce patient burden, accelerate timelines and increase efficiency.
澳门葡京赌博游戏越来越多地利用平台研究进行早期临床试验，比较针对单一疾病的多种潜在药物. 例如, 患者可以根据其特定疾病的不同亚型的生物标志物测试结果参加心血管疾病的平台研究. Depending on the response to the initial 治疗, patients can then potentially switch to other drugs on the platform trial, as indicated by their disease biomarkers.
By designing patient-centric trials, improving the patient experience, and using 数字 technology, we are continually expanding our ability to reach diverse patient populations.
Delivering sustainable clinical trials for the health of society and the planet
Improving inclusion and diversity in our clinical trials
We are committed to designing clinical programmes with equity at the forefront – from idea inception to patient care. 澳门葡京赌博游戏的方法 includes increasing the diversity of clinical trial participants, so trials better reflect the patients who may use our medicines, which ensures we have a robust and reliable body of evidence.
在澳门葡京赌博游戏的临床试验中优先考虑多样性是满足患者和监管机构需求的关键——这也是简单的“好科学”。
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. 从研究设计到数据分析，澳门葡京赌博游戏在整个临床试验过程中使用了大量的操作和数字健康解决方案. Our operational innovations include decreasing face-to-face meetings and clinic visits for patients, reducing the number of wasted lab kits by better predicting where they are needed, diverting unused kits to other healthcare facilities and cutting back on single-use plastic.
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
Increased access to clinical trials and less burdensome clinical trial experience
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
Reduced timelines and trial populations that better reflect clinical practice
Latest updates in clinical innovation
结果
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Veeva ID: Z4-56718
Date of preparation: July 2023