Phesi, a data-driven provider of clinical development analytics products and solutions, has added a new country selection functionality to ClinSite. This AI platform provides investigator site intelligence to clients, enabling investigator site selection and management.
The new functionality has been added in response to the industry-wide problem of non-performing countries and sites being included in clinical trials. An analysis of more than 3,000 trials shows that on average, 31% of participating countries did not contribute patients adequately. ClinSite is an AI-powered tool including data from 4.2m physicians and 600,000 investigator sites, identified from over 80,000 sources and 330,000 clinical trials in more than 200 countries. The country selection functionality is powered by real-time enrolment data from live trials and will allow users to select top-performing countries and sites globally when planning a trial.
“Too often, a trial is executed in a country without access to the right patient population and countries are selected to participate in a trial based on insufficient data,” commented Dr. Gen Li, Founder and President, Phesi.
“This is a long-standing issue for the industry but given the impact of COVID-19 it cannot continue – all companies and nations are facing considerable economic downturn. Our recent data analysis shows that inadequate country selection can cost up to $2.4m per trial, sponsors have to be able to take a data-driven approach and establish which countries have the most high-performing investigator sites for their indication and exactly which sites those are. Failure to do so will continue to waste resources and delay treatments reaching patients.”
A common mistake made in trial protocols is choosing a country because it has a high number of experienced investigator sites, but this does not guarantee it will deliver patients. Often this is caused by competition; for instance, competition for patients in cancer trials in the US is very high. Or, countries can have the same amount of investigator sites but vastly different numbers of unique investigators, so statistically one is more promising than the other. Because the country selection functionality is refreshed with patient enrolment data in real-time, sponsors can plan with confidence and reduce wasted spend. Users can choose the best sites based on parameters including, enrolment, data quality, and speed of site activation; Phesi says it can increase enrolment by up to 40%.
“Because ClinSite’s new country selection functionality is updated dynamically, sponsors can understand at a granular level the population available to participate in their trial. Combined with other capabilities in Phesi, this enables far more successful protocol design and design optimization,” continued Dr. Li. “This means that fewer trials have to be ‘rescued’ down the line. It also eliminates the significant costs incurred and time spent handling ‘change orders’ issued by CROs when a site is not performing, who then exacerbate the problem by recommending more potentially non-performing countries and sites compounding the issue further. By making use of available data, ClinSite lets biopharmaceutical companies and sponsors make evidence-based decisions that lead to successful trials.”