Phesi launches AI-driven Trial Accelerator™ to enable simulated trials and deliver comprehensive view of the patient throughout clinical development and commercialization

Integrated SaaS platform brings together data from 60+ million patients and 485,000 clinical trial records, typically saving up to $7,000,000 per phase III trial

Boston, USA, October 18^th 2022. Phesi, a global provider of patient-centric data analytics, has today launched its AI-driven Trial Accelerator™ platform to facilitate real-time scenario modelling across patient, endpoint, country, KOL and investigator site allocation. Underpinned by the world's largest, most dynamic clinical trial database, the SaaS platform enables clinical development personnel to optimize study design and simulate trial outcomes. By enabling planners to make objective decisions based on real-world data, Phesi saves customers an average of $7,000,000 per phase III trial. Further, the platform reduces the risk of avoidable protocol amendments. With industry data showing that the average phase III protocol experiences 3.3 substantial amendments at a cost of $500,000 per amendment and cumulatively adding 5.2 months of implementation time, Phesi’s Trial Accelerator™ can save sponsors up to $1,500,000 per trial in amendments alone.^[1]

The Trial Accelerator™leverages clinical study data, including control arm data, to accelerate product development and commercialization. The methods and AI models used have been created and validated over the past 15 years and are proprietary to Phesi. The platform powers clinical development decision making by connecting the design to execution, and allowing study teams to design smarter trials to develop faster cures. By delivering a comprehensive and consistent view of the patient throughout the process, it improves the overall probability of success. Phesi partners will also benefit from access to real-world data by being able to create digital patient profiles, digital twins and digital control arms (DCA), including external control arms.

“The industry needs a way to build the bridge between data and insight to deliver truly patient-centric trials. After years of upheaval from Covid-19 and with global events having huge impact on clinical development, being able to predict outcomes and minimize both risk and impact on patients, is critical,” commented Dr Gen Li, CEO and Founder, Phesi. “The pandemic has also shown us what the biopharmaceutical industry is capable of when we work at speed. We need to replicate this approach in other areas of development and commercialization through the use of data analytics and technology. We have almost two decades experience helping our customers achieve this goal and enabling data-led development. Existing functions of clinical trials are siloed and patient profiles are not always consistently understood. Our integrated, AI-led approach to data science solves this problem. The platform also opens the door to the routine deployment of digital twins and digital control arms, to drive further innovation in clinical development and reduce patient and site burden.”

Platform users, including heads of development, medical directors, clinical and portfolio leads, heads of medical affairs, value and outcome research teams, and feasibility groups can pursue targeted treatment analytics, design diverse clinical trials, and access comparable data – all from within the same analytics environment. The platform integrates global portfolio, protocol design, clinical operations, CRO, country, KOL, investigator site and commercial data. It allows companies to design protocols that accurately reflect the patient population. Based on the most comprehensive and dynamic clinical development database, users can leverage real-time data to simulate clinical trials and predict patient outcomes. The Trial Accelerator™ launches with four key modules.

• Patient Profile View gives planners and protocol designers a data-driven understanding of the relevant global patient population. It enables users to create a digital patient profile including all variables – such as comorbidities, demographics/diversity, concomitant medications, and identification of modal inclusion/exclusion criteria values, to accurately model ‘what if…?’ outcomes and patient pathways.
• Trial Performance View minimizes avoidable amendments, saving an estimated $500k per amendment and 5.2 months of additional implementation time. Customers can use modal design value simulation from similar ongoing or completed trials or research protocols and amendments, to simulate enrolment cycle time predictions and the optimum number of investigator sites based on design parameters.
• Country Performance View allows feasibility groups to select and profile the highest performing countries for their indication and carry out accurate recruitment scenario modelling. It lets users identify and understand the highest performing countries by phase and indication (including biomarkers) based on real world data, including variables such as enrolment performance, time to activate, standard of care and indication performance score.
• Investigator Site Performance View enables development companies to select sites for participation and reduce non-active, non enrolling sites to under 10%. It gives users performance-based ranking of KOLs and investigator sites by country, indication, biomarker and phase, derived from proprietary statistical models measuring past performance in site activation, patient enrolment and patient data quality.

“The industry needs to make trials faster and cheaper, while keeping the patient as the priority. The new platform does this by validating or challenging protocol design and execution principles, moving from a perception-led to a data-led approach to studies in planning or in flight,” commented Jonathan Peachey, Chief Operating Officer, Phesi. “We can eradicate the reliance on “gut feel” or past experience that defines much decision making in clinical development today. Phesi makes sure companies learn from the past by simulating the future, by delivering simulated clinical trial outcomes with AI-powered patient-centric data science. Our customers have requested access to the Phesi data, insights and answers via a product in the hands of in-house staff and partners, to empower them to leverage AI and analytics. The Trial Accelerator platform delivers on this demand and allows teams to design smarter trials to deliver faster cures.”

Phesi consulting teams are available to support clients with program design and delivery, for complex projects including Digital Twin and Digital Control Arm analysis, or where clients want to outsource the analytics support. The fully searchable, AI-powered SaaS Trial Accelerator™ platform is available from October 2022.

For more information, please visit www.phesi.com/trial-accelerator/.

^[1] Tufts Center for the Study of Drug Development (CSDD), The Incidence of Protocol Deviations and Amendments is High and Rising, January/February Vol. 24 No. 1:  https://csdd.tufts.edu/impact-reports