Israel-based PhaseV has partnered with clinical research organisation iOMEDICO to introduce a new machine learning (ML) powered solution aimed at optimising and de-risking Phase III oncology clinical trials.

The collaboration offers a virtual analytical framework that integrates Phase II results with real-world data and causal ML to better inform pharmaceutical and biotech companies and optimise their clinical trial decisions.

The newly launched solution leverages iOMEDICO’s extensive real-world oncology data and PhaseV’s causal ML technology.

It offers sponsors a set of tools for standard-of-care enrichment, endpoint modelling, and subgroup identification, enabling a more precise understanding of drug performance.

As a result, the solution allows for the refinement of Phase III trial designs to achieve successful outcomes.

iOMEDICO CEO Michael Pröschel said: “Global cancer cases are rising significantly, yet failure rates of oncology drug candidates to receive regulatory approval remain high.

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“The addition of prospectively collected clinical-grade real-world data to Phase II 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 III oncology trials, helping to bring new therapies to market.”

The technology from PhaseV is designed to mitigate risks and optimise trials by analysing a wide array of factors that could affect a trial’s success, from patient recruitment rates to therapeutic responses.

PhaseV CEO and co-founder Dr Raviv Pryluk said: “Oncology drug candidates are subject to unique challenges when reaching Phase III clinical trials.

“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 III 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.”

Last year, PhaseV raised $15m in funding led by Viola Ventures and Exor Ventures, including participation from LionBird and a group of prominent angel investors.