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

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是一种商用软件平台，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。该项目的产出将有助于提高保健治疗的效率和成本效益。目前，90%正在开发的新疗法在临床试验中失败。虽然有些失败是由于疗效或安全性问题，但许多失败是由于可以避免的问题，这些问题可以在临床试验设计期间解决。现在可以使用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，从而实现更好的试验设计。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，将成功率提高41%，节省了时间和金钱。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来支持临床试验，这是一个强大的商业机会。这尤其及时，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。KerusCloud的成功开发将重新定义试验设计，使Exploristics成为医疗保健发展中统计、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。英国在生命科学研究方面处于全球领先地位，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。通过帮助英国成为临床试验的全球创新中心，并通过促进新的创新药物的有效交付，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。

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.