A new free service will offer insights in under ten days to sponsors conducting clinical trials, identifying potential ‘zombie trials’ and providing actionable recommendations for failing trials.
The Health Check and Trial Rescue Service is an initiative of data software and services company Phesi. The service will use the company’s AI-driven Trial Accelerator Platform to assess protocols in terms of patient view, country view, site view and investigator view.
It draws on 90,000 sources, including more than 4,000 disease indications and 70.8 million patients, with methods and AI models created and validated over the past fifteen years.
Once a protocol is submitted, Phesi will provide insights on key design elements such as inclusion and exclusion criteria.
In July 2023, Phesi released data showing that, in the first half of 2023, 31% of trials at Phase II had been cancelled.
“The clinical trials industry is facing a chronic challenge,” commented CEO and founder of Phesi, Dr 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.”
Protocol amendments slow down clinical development and are extremely costly. The average Phase III protocol experiences 3.3 substantial amendments, with an average cost of $500,000/amendment and cumulatively adding 5.2 months of implementation time.
The Health Check and Trial Rescue Service will include insights into enrolment data to predict and maximise patient enrolment, identifying root causes of underperformance, monitoring site activation progress, and assessing CRO run sites.