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人体临床试验相关，Lindus的目标是开发第一个能够自动实时临床试验数据捕获，分析和预测的软件解决方案-利用临床数据管理（定义为试验数据的收集，整合和验证）中的已知差距。该方法是专门为应对试验发起人（通常由制药和生物技术公司代表）提出的挑战而设计的，以应对对快速药物开发过程日益增长的需求，提高患者安全性和提高数据输出质量的动力。该方法显著推进了当前的临床数据管理流程，该流程以手工纸质数据输入和电子数据捕获为中心，通常回顾性地进行解释（在某些情况下，在试验完成几个月后），提供了更大的数据质量问题风险，并且无法识别风险/质量/安全问题。由于有可能加速交付并降低临床试验成本（高达25%），拟议的解决方案具有显著的增长潜力，作为一种颠覆性创新，完全满足试验发起人和监管机构的需求。它将由一家成熟但发展迅速的合同研究机构在全球范围内进行开发，该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（现有功能包括研究设计、患者招募能力和试验管理）的一部分，并为一系列客户准备采用该产品。Innovate UK的支持将加速拟议的15个月工作计划，使Lindus（以James Lind命名，他在18世纪率先进行了第一次临床试验）在临床数据管理系统市场中获得主导地位，目前价值19亿美元，计划在英国，欧盟和美国开发

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.