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Clinical Insider
Clinical Insider

Phesi sets out to rescue studies and help sponsors avoid amendments

Posted by on 31 October 2023
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Phesi has launched an artificial intelligence-based clinical trial “rescue service” with the aim being to help drug developers identify and fix failing studies.

The service – which will be provided free of charge – will enable sponsors to submit their protocols for a review, offering real-time insights and forecasting within ten working days.

According to CEO, Gen Li, failure to identify problems during the protocol design stage are a major issue for the biopharmaceutical industry.

“Once a trial is underway, sponsors are often forced to amend the protocol to better align with the targeted patient population, often with millions of dollars on the line. Further, we know around a fifth of trials designed today will fail and that many “zombie” trials continue to run, mostly caused by inadequate protocol design.

“Phesi’s new Health Check and Trial Rescue Service addresses these issues by conquering two evergreen challenges: too many protocol amendments and too many failures to complete enrollment as planned” Li said.

In clinical trials protocol amendments slow down clinical development and are extremely costly.

According to research by the Tufts Center for the Study of Drug Development (CSDD) the average Phase III clinical trial protocol is subject to 3.3 substantial amendments at a cost of around $500,000 per amendment.

In addition, these enforced protocol changes extend study duration by 5.2 months on average.
To try and address these issues Phesi service will use study data – including control arm data – to inform clinical development planning and decision making, eliminating costly amendments.

According to the firm “The service will enable sponsors to make data-informed decisions at every stage of the trial planning and execution process.

“This includes better understanding enrollment data to predict and maximize patient enrollment, identifying root causes of under performance, monitoring site activation progress, and assessing CRO run sites.”


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