Expansion of a clinical trial modelling and simulation platform to optimise trial design and facilitate synthetic data generation

扩展临床试验建模和模拟平台，以优化试验设计并促进合成数据生成

• 批准号: 10000902
• 金额: $ 43.36万
• 依托单位: EXPLORISTICS LTD
• 依托单位国家: 英国
• 项目类别: Responsive Strategy and Planning
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10000902
• 关键词: Expansion; clinical; trial; modelling; simulation

Exploristics is a rapidly growing company providing data analytics products and biostatistics services to the Pharmaceutical industry. Our flagship product, KerusCloud, is a commercially available software platform that reduces the risks, costs and duration of drug development. This project aims to extend the KerusCloud capabilities by enabling and exploiting access to disparate datasets. The outputs of the project will help to deliver more efficient and cost effective development of healthcare treatments.Currently, 90% of new treatments in development fail during clinical trials. Whilst some failures are due to efficacy or safety issues, many are due to avoidable issues that could be resolved during the design of clinical trials. Better trial design can now be achieved using KerusCloud which examines all possible design options by simulating studies in a virtual environment. This ensures the best design and analysis approach can now be chosen for real trials, improving the probability of their success by 41%, saving time and money.The main objective of this project is to create a uniquely powerful clinical trial design tool that can evaluate the performance of any clinical trial before the actual study is conducted. To do this, we will enable better use of existing data as part of the design process. This will allow us to make better assumptions and more informed decisions prior to the start of the study as well as learn from the outcomes of completed studies.There is a strong commercial opportunity in providing cost effective intelligent trial design software to support clinical trials. This is particularly timely as the Pharmaceutical industry is now actively seeking ways to improve clinical trial efficiency to accelerate development timelines in the context of the global COVID-19 pandemic, potentially reducing barriers to uptake of new technologies.This project will be transformational for Exploristics as successful development of KerusCloud will redefine trial design, uniquely positioning Exploristics as the global leader in the strategic application of statistics, modelling and artificial intelligence for healthcare development. The project will also have broader impact. The UK is a global leader in life sciences research so this project will also help to fully exploit the research infrastructure and available data resources. This could have a far-reaching impact on drug development and healthcare provision in the UK and globally by helping to establish the UK as a global innovation centre for clinical trials, and by facilitating the efficient delivery of new innovative medicines.

Exploristics是一家快速发展的公司，为制药行业提供数据分析产品和生物统计服务。我们的旗舰产品KerusCloud是一个商用软件平台，可降低药物开发的风险、成本和持续时间。该项目旨在通过启用和利用对不同数据集的访问来扩展KerusCloud功能。该项目的成果将有助于提供更有效和更具成本效益的医疗保健治疗开发。目前，90%的新疗法在临床试验期间失败。虽然一些失败是由于有效性或安全性问题，但许多失败是由于可以在临床试验设计期间解决的可避免问题。现在可以使用KerusCloud实现更好的试验设计，KerusCloud通过在虚拟环境中模拟研究来检查所有可能的设计选项。这确保了最佳的设计和分析方法现在可以选择真实的试验，提高其成功的概率41%，节省时间和金钱。该项目的主要目标是创建一个独特的强大的临床试验设计工具，可以在实际研究进行之前评估任何临床试验的性能。为此，我们将更好地利用现有数据作为设计过程的一部分。这将使我们能够在研究开始之前做出更好的假设和更明智的决定，并从已完成的研究结果中学习。提供具有成本效益的智能试验设计软件以支持临床试验具有很大的商业机会。这是非常及时的，因为制药行业目前正在积极寻求提高临床试验效率的方法，以在全球COVID-19大流行的背景下加快开发时间表，从而可能减少采用新技术的障碍。该项目将对Exploristics产生变革，因为KerusCloud的成功开发将重新定义试验设计，将Exploristics定位为医疗保健发展统计、建模和人工智能战略应用的全球领导者。该项目还将产生更广泛的影响。英国是生命科学研究的全球领导者，因此该项目也将有助于充分利用研究基础设施和可用的数据资源。这可能对英国和全球的药物开发和医疗保健提供产生深远的影响，有助于将英国建立为全球临床试验创新中心，并促进新的创新药物的有效交付。