Solving for Non-Active and Non-Enrolling Sites: Q&A with Dr. Gen Li

Dr. Gen Li
Founder and president
Phesi

The site selection process is one of the most important steps in the clinical trial process. Many companies are facing issues with dealing with poorly performing sites. Dr. Gen Li, founder and president of Phesi, spoke with Pharmaceutical Executive about the ways companies can improve this process.

Pharmaceutical Executive: How big of an issue are non-active and non-enrolling sites?
Gen Li: Selecting the best investigator sites has always been challenging, but the clinical development industry is approaching a crisis point. Rapid advances in precision medicine have stratified patient populations, yet the same level of precision is not applied to investigator site selection. As a result, there are a significant proportion of non-active and non-enrolling investigator sites that unnecessarily increase costs, prolong cycle times, and deliver minimal or even no patient data.

The saturation of investigator sites in certain areas further compounds the problem, contributing to the already high number of poorly performing sites. This is a particular challenge in oncology, where three of the top five most studied diseases in 2024 are found. Enrolment data from oncology trials show that nearly one in five investigator sites enrolled just a single patient, delaying the delivery of lifesaving medicines to patients and increasing costs.

To increase the success rate of trials, sponsors must adopt a data-driven approach to trial design, identifying the most experienced investigators and selecting investigator sites with precision. Achieving this requires the use of real-world data from previous and ongoing clinical trials, and the use of Digital Patient Profiles – to gain a deep understanding of the target patient population. With a comprehensive patient view from the outset, sponsors can optimize trial design, reduce patient burden, and select investigator sites with far higher precision.

PE: Why are the costs for single-patient sites so much higher per patient?
Li: Poorly performing investigator sites incur higher costs primarily due to operational expenses, with a single-patient site having an average cost-per-patient that is ten times higher than a better performing site. Regardless of patient volume, every investigator site must maintain essential infrastructure, administrative processes, and staffing. For single-patient sites, the total cost of these resources is allocated to just one patient, resulting in significantly higher per-patient costs.

Single-patient investigator sites also lack the efficiencies that come from managing multiple patients simultaneously. Well-performing sites can batch certain activities like data entry and protocol training, making processes quicker and less costly per patient. Another problem is that single-patient sites cannot benefit from bulk ordering of medical supplies and equipment, forcing sponsors to pay higher rates per patient.

PE: What are the benefits of being able to check the status of sites prior to conducting clinical trials?
Li: Checking the status of investigator sites before conducting clinical trials allows sponsors to exclude under-performing sites and select locations with greater precision and confidence. Typically, investigator site lists are created based on internal nominations, suggestions from development partners and CROs, or familiarity with certain locations and institutions, with limited ability to verify if those suggestions are optimal based on external trial factors.

However, with advances in data and AI technology, sponsors can validate these selections by using investigator site data, making decisions based on real insights rather than gut feeling and previous experience. In today’s fast-paced clinical landscape, it is essential to objectively identify the best investigator sites and verify external proposals–both at the pitch stage and throughout delivery–using the latest and most accurate real-world data.

PE: How comprehensive are the site profiles that are generated by your AI-powered technology?
Li: Investigator Site Profile leverages data from Phesi’s AI-powered Trial Accelerator platform, which includes records from 600,000 investigator sites across 195 countries and 120 million patients. These data are used to create profiles of investigator sites that contain information on the site’s clinical experience with the specific indication under study, historical trial capacity, current research workload, and the investigator’s medial expertise. Each profile also provides a composite performance score that evaluates the investigator site’s activation speed relative to peers, patient enrolment effectiveness, and consistency in delivering quality patient data.

Moreover, the level of precision can further be improved through Patient Access Score, where we identify the investigator sites with proven records to have access to the patient population aligned with the targeted patients as defined by the design of the trial. The characteristics of that targeted patient population is Digital Patient Profile.

We’ve found that this data-driven approach–combined with Digital Patient Profiles and Patient Access Scores–has enabled sponsors to reduce their single patient sites to under 10%, by pinpointing investigator sites suited to specific patient populations and ensuring the trial aligns with the investigator’s capabilities.