Phesi, a leading clinical development analytics company, has launched a self-service Investigator Site Profile solution designed to eliminate the non-active and non-enrolling investigator sites that development programs are typically burdened with. Investigator Site Profile leverages data from Phesi’s award-winning AI-powered Trial Accelerator™ platform, including records from 600,000 investigator sites in 195 countries. Users of the solution can access a detailed profile of investigator sites to select the best locations for the design of their study. Each profile contains the following data:
- Investigator site clinical experience and relevance to indication under study.
- Historical clinical trial capacity and current research workload at each investigator site, including competitor trials.
- Profile of the investigator’s medical expertise based on data derived from his/her involvement in clinical research and clinical development.
- A composite investigator site performance score consisting of three elements: speed of site activation compared to peers, patient enrolment compared to peers in a particular clinical trial he/she participated in, and their ability to deliver quality patient data consistently.
“Our analyses have revealed that there are a significant proportion of non-active and non-enrolling sites that add unnecessary expense and time, and which have an extensive impact on successful clinical development outcomes,” said Dr Gen Li, Phesi CEO. “Selecting the best investigator sites has always been challenging, but we are approaching a crisis point. Rapid progress achieved in precision medicine has stratified patient populations, but the same level of precision is not yet given to investigator site selection, leading to unsuitable sites delivering minimal or even no patient data. Investigator Site Profile overcomes this by democratizing access to data – enabling sponsors to exclude under-performing sites and select locations with precision and confidence. Typically, an investigator site list is produced from internal nominations, suggestions from development partners, or even simply based on familiar locations or institution names. With Investigator Site Profile, sponsors can sanity check their ‘gut feel’ and historic experience. And in a fast-moving clinical landscape, it is essential to objectively identify the best investigator sites and verify CRO proposals both at the pitch and also in delivery based on the latest and most accurate real-world data.”
The saturation of investigator sites in certain areas increases the number of poorly performing sites. This is a particular challenge in oncology, where three of the top five most studied diseases are found. A previous Phesi analysis of enrollment data from oncology trials using traditional tools and approaches found nearly one in five enrolled just a single patient. Further detailed Phesi analysis in non-small cell lung cancer (NSCLC) trials underlines the problem. The analysis found that 471 recruiting Phase I NSCLC trials targeted more than 20 specific genetic markers; a fifth (20%) of the investigators working on these 471 NSCLC trials were shown to specialize in different areas of oncology, with no history of strong recruitment in lung cancer. Additionally, the top 100 lung cancer investigator sites in the US each recruit for 39 trials on average; a single investigator cannot meaningfully recruit patients for 39 trials.
Dr Carl Mason, Chief Medical Officer at Lumen and an Investigator Site Profile beta user, commented: “Investigator site selection is a significant concern for many heads of clinical operations and development. Previously, there was limited ability to verify that sites proposed internally or by a CRO using conventional methods were optimal for each study. Phesi’s Investigator Site Profile provides increased confidence and quality assurance in the site selection process. We have also observed notable advantages from collaborating with Phesi on patient-led protocol design analysis. Furthermore, the nomination of investigator sites based on their contribution of baseline data to the Phesi Digital Patient Profile has provided valuable insights into how individual sites can potentially support our enrollment objectives.”
The new solution is integrated into Phesi’s suite of existing tools for optimizing clinical development programs and execution delivered through Trial Accelerator, alongside Digital Patient Profile (DPP) and Patient Access Score (PAS). Investigator Site Profile is available to users as a self-service solution; users can review their existing list of nominated investigator sites, including lists via a CRO, for clinical relevance, workload and various performance scores.
Phesi can also deliver more comprehensive investigator site selection at disease level; using Investigator Site Profile alongside Phesi consultative services to produce a list of relevant investigator sites for disease under study. Further, Phesi can work with clients to provide investigator site selection specific to the patient population targeted by a particular clinical trial; using Investigator Site Profile, combined with DPP and PAS, alongside Phesi consultative services to identify specific patient populations and their physicians.
Phesi was recognized in September 2024 by Frost & Sullivan with the Global Enabling Technology Leadership Award, for revolutionizing clinical development with its AI-powered Trial Accelerator platform and patient-centric analytics tools. The annual award is presented to a company that has developed pioneering technology to enhance current products and enable the development of new products and applications. Trial Accelerator is the industry’s largest contextualized clinical trial database; it serves as a bridge between protocol and program design, patient profiling, and high-performance investigator sites.
