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Clinical Trials Innovation Summit 2024

Revolutionizing Clinical Trial Central Monitoring: Automated Quality Assurance for Faster, Scalable Monitoring by Rachel Newsome, PhD

Tuesday 22nd October at 15:45 

Accurate administration of rater-based clinical instruments, such as the Clinical Dementia Rating (CDR), is critical for reliable clinical outcomes in Alzheimer’s Disease (AD) trials. However, existing gold-standard quality assurance (QA) processes rely heavily or entirely on manual expert reviews, which are costly, time-consuming, and challenging to scale. These limitations contribute to variability in clinical ratings, potentially affecting therapeutic signal detection and trial outcomes.

Automated digital solutions have the potential to transform clinical trial operations, especially in the central monitoring and QA. By leveraging AI, including speech biomarkers and natural language processing (NLP), we can automated central monitoring, reduce reliance on manual reviews, and significantly improve scalability.

In this talk Rachel will discuss research from Cambridge Cognition highlighting three key advancements:

  1. How non-experts, supported by digital tools, can flag deviations in Clinical Outcome Assessment (COA) administration with expert-level accuracy.
  2. How AI-powered tools can automatically detect administration errors in COAs, specifically in the CDR.
  3. How speech biomarkers can be integrated into more precise and effective monitoring tools.

The ultimate objective is to provide faster, more accurate quality reviews, maintaining gold-standard precision. By automating these processes, we can identify and remediate errors earlier, preventing them from undermining the accuracy and integrity of clinical trials. This approach enhances both trail efficiency and data reliability, contributing to more robust therapeutic outcomes.

Want to know more?

Get in touch below and we will share Rachel’s content with you following her presentation. If you have any questions, please send us a message and one of the team will be in touch!

If you have any questions or would like to discuss any of our research, or how we can support your projects, complete the form below and our team will be in touch!

Author

Rob Baker
Chief of Product & Operations

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