Phesi files patent for clinical trial protocol development method, system

By Melissa Fassbender

- Last updated on GMT

(Image: Getty/simarik)
(Image: Getty/simarik)

Related tags: Patent, Patent application, Clinical trial, Patient recruitment

The clinical development services provider Phesi is looking to patent its method and system for developing clinical trial protocols – which enables faster patient enrollment and study completion, says CEO.

The patent application #2549-PRO was filed with the United States Patent and Trademark Office (USPTO).

Founded in 2007, the Phesi’s clinical trials database includes 213,000 interventional, randomized clinical trials, 604,000 completed clinical research projects, and more than 1.6m investigator records from multicenter interventional clinical trials.

Gen Li, PhD, MBA, founder and CEO of Phesi, said, “Phesi brings clinical trial planning into the 21st century.”

The company’s protocol design and optimization platform addresses several common issues by leveraging its clinical development database in combination with human intelligence as well as expert insight and analysis, said Li.

Phesi’s approach uses millions of automated, dynamic, and real-time data sources. “It enables faster patient enrollment and trial completion by facilitating assessment of competitive trial sites and identifying optimal sites,”​ Li told us.

The main points of the patent cover the analysis of large clinical protocol datasets to establish a “base case protocol”​ that can be compared and contrasted with a client's protocol in development, Li explained.

“Knowing the specific protocol design elements from the client that deviate from the base case protocol permits modeling with baseline patient characteristics to quantify the impact on enrollment,”​ he added.

The analysis is supplemented by an estimate of enrollment rates, which subsequently allows the company to estimate enrollment cycle times for a specific protocol sample size. 

As Li explained, modeling shows that the higher the number and degree of deviations, the greater the enrollment cycle time and the greater risk of trial failure for insufficient enrollment.

“The right investigator site is not worth very much without the right protocol,” ​he added. “Knowing how similar protocols have succeeded or failed is important in designing a new one.”

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