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PhaseV, a pioneer in causal machine learning (ML) for clinical trial analysis and optimisation, announced it has partnered with oncology- and hematology-focused clinical research organisation (CRO) iOMEDICO to launch a new virtual analytical framework solution for pharma and biotech companies that seek to optimise and de-risk phase 3 oncology clinical trials.
A substantial proportion of cancer drug candidates that succeed in phase 2 trials ultimately fail in phase 3, due to a variety of reasons. These include failure to prove significant superiority over standards of care (SoC), different endpoints criteria across the phases, and more diverse patient representation in phase 3 trials.
The new solution, built on iOMEDICO’s proprietary real-world oncology data and PhaseV’s proprietary causal-ML technology, addresses these challenges by providing tools for SoC enrichment, endpoint modelling, and subgroup identification. This enables sponsors to better understand how their drug will perform and then optimise the design of the phase 3 trial to achieve efficient and successful outcomes.
“Global cancer cases are rising significantly, yet failure rates of oncology drug candidates to receive regulatory approval remain high," said Michael Pröschel, CEO of iOMEDICO. “The addition of prospectively collected clinical-grade real world data to phase 2 results adds vital information to understanding how new treatments work across patient populations. Our expansive database in conjunction with PhaseV’s proven technology is a critical step forward in improving phase 3 oncology trials, helping to bring new therapies to market.”
iOMEDICO’s proprietary real-world clinical oncology data—including biomarkers—is aggregated from more than 50,000 patients. The combination of longitudinal real-world data along with specific phase 2 trial data, feeds into PhaseV’s technology, contributing to a deep understanding of oncologic subpopulations. This aids in the simulation and design of successful phase 3 trials, thereby increasing sponsors’ confidence in approaching pivotal trials.
“Oncology drug candidates are subject to unique challenges when reaching phase 3 clinical trials,” said Dr. Raviv Pryluk, CEO and Co-founder of PhaseV. “The solution we have created leveraging iOMEDICO’s real-world data enables us to address these challenges through a virtual platform that mimics how a drug will perform in a phase 3 setting. Our platform will help promising drugs reach their full potential and cross the finish line, ultimately resulting in new treatment options that can help improve outcomes for people living with cancer.”
PhaseV’s proprietary technology promotes trial de-risking and optimisation by analysing the plethora of factors that may potentially impact a trial, from recruitment rate to patients’ response to therapy. The causal ML solution detects hidden signals in clinical data, and enables assessment of endpoints and patient subpopulations to improve trial outcomes.