Combining Deep Site Data and AI Capability to Advance Clinical Trials

A multiyear partnership leading to an enterprise application combining extensive patient recruitment and site performance data with predictive models and advanced analytics, has been announced by Thermo Fisher Scientific Inc.

Medidata Acorn AI, a Dassault Systèmes company focused on the digital transformation of life sciences and Thermo Fisher’s PPD clinical research business are collaborating on the development of the PPD TrueCast platform that can offer wide-ranging representations of real-time site performance combined with machine learning, that will give pharmaceutical and biotech companies actionable insights in optimisation of clinical research site selection, trial enrollment and study cycle times.

“The clinical trial industry continues to demand new tools in big data and predictive analytics to improve trial planning and execution and accelerate clinical trials,” said David M Johnston, PhD, Senior Vice President and President, Clinical Research, Thermo Fisher Scientific. “As a result of the vast site-level data amassed by PPD and Medidata, customers now have even greater visibility into how a trial is performing for any study our clinical research business is helping them run. We already have successfully deployed these machine learning-based insights to give us a competitive site selection advantage in the crowded trial landscape.”

Utilising artificial intelligence (AI) models to forecast cycle times and enrollment performance, the platform can automatically track study performance and predict enrollment risk. When mitigation is needed, the application provides access to real-time site performance metrics to identify high-performing sites.

 “AI and advanced analytics play an increasingly critical role in a rapidly changing clinical trial environment," said Fareed Melhem, Senior Vice President, Medidata Acorn AI. "We’re delighted to be working side by side with Thermo Fisher’s clinical research business to combine our technology, data and expertise. Together, we are now offering companies new ways to rethink their clinical trials through access to live, cross-industry site performance data.”

The TrueCast platform builds upon Thermo Fisher’s clinical research business’ data from 40,000 sites, 50,000 investigators and more than 2,000 studies, along with Medidata’s unique datasets generated from more than 26,000 clinical trials and nearly 8 million patients in more than 140 countries across the globe. This powerful, combined resource has led to the average Phase III study enrollment period being reduced by an average of 1.5 months in retrospective trial simulations when site recommendation models were utilised to select a portion of the country and site footprint. Thermo Fisher also expects to realise a 30% increase in the accuracy of forecasting trial milestones, the company added.

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