The company that provides patient-centric data software announced its new health check and trial rescue service on Thursday last week (October 12). It says this will enable sponsors to submit their protocols for review by Phesi offering real-time insights and forecasting within ten working days.
The service will run using Phesi’s artificial intelligence (AI) driven trial accelerator platform to assess protocols in terms of patient view, country view, site view and investigator view.
Phesi’s data includes 90,000 updated sources and more than 4,000 disease indications and 70.8 million patients with methods and AI models created and validated during the past 15 years. Once the company receives the protocol, Phesi will provide insights on key design elements such as inclusion and exclusion criteria.
“The clinical trials industry is facing a chronic challenge,” commented CEO and founder of Phesi, Gen Li.
“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 enrolment as planned. With this service, sponsors can take a proactive, data-driven approach – they won’t need to wait until a study is at risk of failing before they take action.”
In its research, Phesi found that protocol amendments slow down clinical development and are extremely expensive. It says the average phase 3 protocol experiences 3.3 substantial amendments that cost on average $500,000 per amendment and cumulatively adding an additional 5.2 months of implementation time.
The health check and trial rescue service uses clinical study data including control arm data to inform clinical development planning and decision making, eliminating costly amendments. The service will enable sponsors to make data-informed decisions throughout every stage of trial planning and decision making which Phesi says will take out the costly amendments.
Sponsors will now be able to make better data-informed decisions throughout the trial planning and execution process. This includes a better understanding of enrolment data that can help predict and maximize patient enrolment highlighting root causes of underperformance, monitoring site activation progress and assessing CRO run sites.
Jonathan Peachey, chief operating officer at Phesi, said: “We’re launching this new service at the time of year when we know sponsors are considering budgets, reviewing what’s been successful over the past year, and creating their portfolios for 2024.
“The service is designed for everyone – including heads of development, heads of innovation, heads of digital, heads of clinical operations, and heads of portfolios – who would like to gain data-driven insights about the likely outcome of a potential trial, whatever the indication or stage of the trial process. Crucially, the new service will identify any issues in days – rather than months.”