Using machine learning and advanced data science to revolutionise clinical trial data management

结合机器学习和数据科学的创新，并与全球每年进行的所有35K人类临床试验相关，Linds的目标是开发第一个能够自动实时捕获、分析和预测临床试验数据的软件解决方案-利用临床数据管理中的已知漏洞(定义为试验数据的收集、集成和验证)。该方法专门设计用于解决试验发起人(通常由制药和生物技术公司代表)提出的挑战，以应对对快速跟踪药物开发过程的日益增长的需求，以提高患者安全性和数据输出质量。该方法大大推进了当前的临床数据管理流程，这些流程以基于纸质的手动数据输入和电子数据捕获为中心，通常进行追溯(在某些情况下是在试验完成后几个月)，从而提供了更大的数据质量问题风险，并且无法在风险/质量/安全问题发生时识别它们。由于有可能加快交付并降低临床试验成本(高达25%)，建议的解决方案作为一项颠覆性创新提供了巨大的增长潜力，完全满足了试验赞助商和监管机构的需求。它将由一家成熟但快速增长的合同研究机构在全球范围内利用，这些机构率先在临床试验设计和交付中使用人工智能，作为已建立的端到端试验交付平台的一部分(现有功能包括研究设计、患者招募能力和试验管理)，并有一系列客户准备采用该产品。Innovate UK Support将加快拟议的15个月工作计划，使Linds(以18世纪首创临床试验的James Lind命名)在目前价值19亿美元的临床数据管理系统市场获得主导地位，并计划在英国、欧盟和美国进行开发。

Combining innovations in machine learning and data science and with relevance to all 35K human clinical trials performed globally each year, Lindus aim to develop the first software solution capable of automated real time clinical trial data capture, analysis and prediction - exploiting known gaps in clinical data management (defined as the collection, integration and validation of trial data).The approach has been specifically designed to address stated challenges cited by trial sponsors (typically represented by pharmaceutical and biotech companies) in response to an increasing demand for fast-track drug development processes, a drive for improved patient safety and improved quality of data outputs. The approach significantly advances current clinical data management processes which centre around manual paper-based data input and electronic data capture with interpretation typically performed retrospectively (in some cases months after trial completion), providing greater risk of issues in data quality and an inability to identify risks/quality/safety issues as and when they occur. With the potential to accelerate delivery and reduce clinical trial costs (by up to 25%), the proposed solution offers significant growth potential as a disruptive innovation that fully meets the needs of trial sponsors and regulators. It will be exploited globally by an established but fast-growing contract research organisation who have pioneered the use of AI in clinical trial design and delivery as part of an established end-to-end trial delivery platform (existing functions include study design, patient recruitment capability and trial management) with a range of customers ready to adopt the product. Innovate UK support will accelerate the proposed 15-month workplan allowing Lindus (named after James Lind who pioneered the first clinical trial in the 18th century) to gain a dominant position in a Clinical Data Management System Market currently valued at USD1.9 billion with planned exploitation across the UK, EU and U.S.