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，可以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更高效、更具成本效益地开发医疗保健治疗方法。目前，90% 正在开发的新治疗方法在临床试验期间都失败了。虽然一些失败是由于功效或安全问题造成的，但许多失败是由于在临床试验设计过程中可以解决的可避免的问题。现在可以使用 KerusCloud 实现更好的试验设计，它通过在虚拟环境中模拟研究来检查所有可能的设计选项。这确保了现在可以为实际试验选择最佳的设计和分析方法，将其成功的可能性提高 41%，节省时间和金钱。该项目的主要目标是创建一个独特、强大的临床试验设计工具，可以评估在实际研究进行之前进行的任何临床试验。为此，我们将在设计过程中更好地利用现有数据。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策，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来支持临床试验存在着巨大的商业机会。这是特别及时的，因为制药行业现在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，从而有可能减少采用新技术的障碍。该项目对于 Exploristics 来说将是变革性的，因为KerusCloud 的成功开发将重新定义试验设计，将 Exploristics 独特地定位为统计、建模和人工智能在医疗保健发展战略应用领域的全球领导者。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数据资源。通过帮助将英国建立为全球临床试验创新中心，并促进新创新药物的高效交付，这可能会对英国乃至全球的药物开发和医疗保健提供产生深远影响。