临床创新如何帮助减少临床试验对环境的影响

Written by:

Cristina Durán

President of Evinova

Natalie Fishburn

临床操作副总裁,澳门第一赌城在线娱乐R&D, AstraZeneca

Michele Sample

VP Clinical Operations, Oncology R&D, AstraZeneca

Clinical research is key to unlocking new medicines with potential to transform outcomes across many diseases. However, this process has potential to generate up to 100 million tons of carbon dioxide equivalent emissions per year – similar to the yearly emissions of a country the size of Belgium.1 We are using a science-led approach to lower the environmental impact of healthcare and reduce greenhouse gas emissions by running our clinical trials sustainably to create a healthy future for society and the planet.

气候危机是目前人类面临的最大健康威胁之一. 气候变化有可能对健康结果产生负面影响, including exacerbating the prevalence of cardiovascular and respiratory illnesses and placing additional burden on health systems already under pressure.2 At the same time, currently approximately 5% of global greenhouse gas (GHG) emissions are generated within the healthcare sector, which means everyone involved in the delivery of healthcare has a role in driving sustainability and reducing emissions, while improving health outcomes.3

Through a focus on 在临床试验中不断创新, we are pioneering new approaches and embedding sustainability in everything we do – from the lab to the patient. This means leveraging digital technologies and innovative processes to reduce the environmental impact of clinical trials, 同时也改善了病人的就医和体验.

To accomplish this, 澳门第一赌城在线娱乐致力于透明地报告和衡量澳门第一赌城在线娱乐的环境足迹. For example, 澳门第一赌城在线娱乐是第一家使用碳排放指数的制药公司, 一个减少温室气体的工具,供试验小组评估试验的预测环境足迹. This tool is a required part of study design and helps study teams calculate and optimise trial GHG emissions, 在试验设计时将环境影响放在首位.


通过优化使用数字解决方案和其他创新来降低排放, 研究小组使用碳排放指数来计算最近的一项心血管试验 45% fewer GHG emissions (excluding drug manufacturing and supply) compared with similar studies using more traditional designs.


Going forward, we are using a multitude of such operational and digital health solutions throughout the clinical trial process – from study design to data analysis – to help lessen the environmental impact of our future trials.

Early clinical research planning

Before a clinical trial can begin, key stakeholders including site teams, researchers, 医疗保健专业人员必须就进行试验的适当地点数量达成一致. This can require extensive research involving multiple site visits to ensure site processes comply with Good Clinical Practice and that the relevant patient population will have access to the trial. 简化流程,减少对环境的影响, 澳门第一赌城在线娱乐正在使用高级分析来聚合多个数据集, helping us identify the right sites for our clinical trials and reducing the need for multiple site team assessment visits ahead of selecting a site.

当澳门第一赌城在线娱乐计划临床试验时,澳门第一赌城在线娱乐和澳门第一赌城在线娱乐的合作伙伴会考虑:

  • 哪些国家和网站将参与?
  • 澳门第一赌城在线娱乐如何确保目标患者群体的多样化代表?
  • 病人多快能参加这项研究?

Currently, a significant amount of resources can be wasted due to unforseen changes to the original clinical trial plan, 再加上缺乏及时可见的必要修正. To address this, we are using novel planning tools, 跟踪减少废物的目标,作为衡量成功的标准, and continually highlighting the importance of early planning and communication across our clinical trial teams. 
 

临床监测和管理的数字化解决方案

重要的是,澳门第一赌城在线娱乐知道澳门第一赌城在线娱乐并不总是有所有的答案. After listening to patients, 护理人员和试验调查人员并审查澳门第一赌城在线娱乐现有的试验方案, we gathered more than 14,000条关于人们在临床试验中的经验的评论. 反馈清楚地表明,临床试验目前对患者和护理人员的要求很高, with many appointments and measurements – they questioned whether technology could support having some of these assessments at home. Even prior to the COVID-19 pandemic, our teams had already begun seeking possible opportunities for operational adjustment; they reviewed 90 internal trial protocols and determined that collecting certain data at home could reduce visits by around 25% to 40% – which in turn could reduce GHG emissions by an estimated 28%.

At-home digital solutions can also be used to enable trial participants to capture clinically relevant events that could be part of composite trial endpoints. Composite endpoints combine two or more clinically relevant events into a single outcome variable that represents a valid measure of clinical benefit due to a given treatment. A recent study on chronic obstructive pulmonary disease (COPD) showed that using digital solutions and composite endpoints resulted in a trial design that required half the number of patients and half the required visits since more data could be collected over the course of the study compared with traditional COPD studies. 
 


合作对成功的重要性

从操作变化到解决澳门第一赌城在线娱乐如何设计和提供临床试验, 澳门第一赌城在线娱乐在减少温室气体排放方面取得了巨大进展. 通过与外部合作伙伴的合作,澳门第一赌城在线娱乐有可能取得更大的进步.

这就是为什么澳门在线赌城娱乐公司的首席执行官Pascal sooriot召集了这次会议 可持续市场倡议(SMI)卫生系统工作组. This Task Force enables collaboration across the healthcare sector to accelerate the transition to net-zero health systems, 包括脱碳临床试验和病人护理, 利用数字和创新的力量, as well as tackling scope 3 supply chain emissions. 像这样的跨行业合作伙伴关系不仅会推动澳门第一赌城在线娱乐更接近澳门第一赌城在线娱乐的目标 Ambition Zero Carbon targets over the next decade, but they also encourage us to work together to be certain that our contribution to society respects our environment and ensures the sustainable use of the planet’s finite natural resources.

Because clinical trials touch so many aspects of the broader health system (including healthcare facilities, staff and patient travel, medicines manufacturing and delivery), examining how digitalisation reduces emissions in clinical trials shows vast potential for the use of digital technologies in the broader healthcare system.


加入澳门第一赌城在线娱乐:共同努力促进临床试验中的环境可持续性

澳门第一赌城在线娱乐知道,澳门第一赌城在线娱乐的未来取决于为人民的健康采取大胆行动, society, and the planet. At AstraZeneca, sustainability is part of our DNA, embedded in everything we do, from the lab to the patient. 通过为澳门第一赌城在线娱乐的员工提供资源和支持来推动科学的发展, 澳门第一赌城在线娱乐正在超越平凡,帮助改善全球数十亿人的生活.

We welcome committed, talented prospective employees to join us as we pioneer a science-led approach to lower the environmental impact of healthcare and reduce GHG emissions the aim to create a healthy future for society and the planet.


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References

1.  可持续医疗保健联盟,2019年“使临床试验可持续”. [Online]. Available: http://shcoalition.org/clinical-trials/

2.  世界卫生组织,“气候变化与健康”,2021年10月30日. [Online]. Available: http://www.who.int /媒体/新闻/细节/气候变化与健康问题.  

3.  Romanello M. et al. 《澳门在线赌城娱乐》关于健康和气候变化的报告:受化石燃料支配的健康. 2022年10月25日在线发布,网址:http://www.thelancet.http://www.journals /lancet/article/PIIS0140-6736(22)01540-9/全文[最后访问日期:2023年1月].

 

Veeva ID: Z4-60423 
Date of preparation: December 2023