Inka Health and OneMedNet launch AI-powered oncology initiative using external control arms

Inka Health will lead a new initiative with OneMedNet to explore how AI and regulatory-grade real-world data (RWD) can support the development of external control arms in oncology, offering a potential alternative to traditional clinical trials. 

The multi-phase project will examine how RWD, including radiology imaging, can be used to build external control arms (ECAs) that replicate outcomes of traditional oncology trials. The approach aims to support evidence generation for regulatory and reimbursement decisions, while potentially reducing the time, cost, and complexity of standard clinical trials. 

Inka Health, a wholly owned subsidiary of Onco-Innovations Limited, was selected by OneMedNet Corporation to lead the initiative. OneMedNet’s iRWD platform provides access to a federated network of healthcare providers, offering diverse, longitudinal, and regulatory-grade data that can be used to generate real-world evidence (RWE) in cancer research. 

“We selected Inka Health for this initiative because their methodological approach aligns perfectly with our vision for high-quality evidence generation,” said Aaron Green, President & CEO of OneMedNet. “Their ability to apply rigorous, AI-driven analytics to our regulatory-grade, diverse datasets makes them the ideal partner to showcase how OneMedNet’s Real-World Data can be used as a trusted external control arm in oncology research.” 

The project’s initial focus will be on non-small cell lung cancer (NSCLC), one of the most common and clinically significant cancer types globally, where RWD may help address evidence gaps. Inka Health plans to use its SynoGraph platform, which integrates machine learning and causal inference methods, to replicate the Keynote-189 trial of pembrolizumab. The methodology is intended to align with best practices from regulatory and health technology assessment (HTA) bodies, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the UK’s National Institute for Health and Care Excellence (NICE). 

“This collaboration is about more than applying advanced analytics to oncology data,” said Paul Arora, Co-Founder of Inka Health. “It’s about reshaping how we generate credible evidence for regulatory and reimbursement decisions using real-world patients, not just trial participants. With SynoGraph, we’re aiming to set a new bar for how external control arms can be built and trusted.” 

By using existing data in place of traditional control groups, ECAs offer a potential pathway to streamline clinical development, particularly in areas where conventional trials may be impractical or resource intensive. The approach may also support more timely access to treatment, especially in cancer types with limited therapeutic options. 

The project contributes to ongoing efforts to expand the role of RWE in oncology, as industry interest grows in alternatives to randomized controlled trials. The global market for RWE is projected to exceed $4.6 billion by 2030, underscoring demand for scalable and cost-effective methods to evaluate new therapies. 

The collaboration is expected to result in a scientific abstract for submission to ISPOR Europe 2025, highlighting the potential for regulatory-grade RWD to support clinical development strategies. Inka Health and OneMedNet aim to demonstrate how AI-enabled analytics can support industry adoption of ECAs in both regulatory and HTA contexts.