Onco-Innovations Limited's subsidiary, Inka Health, has made significant strides in oncology research with the development of AI-driven synthetic patient models that could transform how clinical trials are designed and conducted, particularly for rare cancers.
The Canadian-based company recently announced that Inka Health led a transformative study protocol published in medRxiv in September 2024, focused on creating synthetic patient data using advanced machine learning techniques. The study, titled "External control arm with synthetic real-world data for comparative oncology using single trial arm evidence: A case study using Lung-MAP S1400I," addresses a critical challenge in oncology research where traditional patient data is often unavailable or difficult to obtain.
Dr. Winson Cheung, medical advisor at Inka Health and professor of medicine at the University of Calgary, led the research team, which included Inka Health co-founders Dr. Paul Arora and Dr. Alind Gupta, along with a consortium of renowned cancer researchers and private sector partners Subsalt and Quantify Health.
"The ability to create synthetic patient models using AI is an exciting milestone for oncology research," said Paul Arora, CEO of Inka Health. "Traditional data limitations have long hindered progress, especially for rare cancers where patient data is scarce. With this technology, we can simulate diverse patient populations, with the potential to improve how clinical trials are designed."
Advancing Clinical Trial Design with Synthetic Data
The research focuses on developing synthetic patient cohorts using AI technology, a core element of digital twin technology. This approach aims to address gaps in oncology research and accelerate clinical trial design by quickly generating comparator arms for trials—particularly critical in rare cancer settings where randomizing patients to control arms is often infeasible.
Dr. Winson Cheung emphasized the significance of this approach: "AI-driven synthetic patient models represent a potentially major leap in oncology research. By generating high-fidelity digital replicas of real patients, we can overcome data gaps that have historically slowed advancements, particularly for rare cancers and underrepresented populations."
Inka Health is working to expand its proprietary AI-driven platform, SynoGraph, which enhances patient stratification, improves clinical trial efficiency, and advances precision oncology solutions. By incorporating synthetic real-world data, SynoGraph aims to offer pharmaceutical and biotech industries a powerful tool to speed up drug development and regulatory processes.
Roche-Sponsored Study Further Validates Approach
Building on this foundation, Inka Health recently published another significant study titled "Quantitative Bias Analysis for the Assessment of Bias in Comparisons between Synthetic Control Arms" in JAMA Network Open in March 2025. This Roche-sponsored research addresses a critical methodological gap in real-world oncology research.
The study, led by Alind Gupta, co-founder of Inka Health, in collaboration with Roche and internationally recognized experts including Harvard Professor Miguel Hernán, introduces a novel approach called Q-BASEL. This method applies Quantitative Bias Analysis (QBA) to external control arm studies, which compare single-arm trial results to outcomes derived from historical or real-world data.
The Q-BASEL study emulated 15 treatment comparisons in advanced non-small cell lung cancer (aNSCLC) by using real-world patient data to recreate experimental arms from previously conducted randomized trials. The research team applied QBA after adjusting for known baseline differences, using evidence from medical literature, clinical trial data, and expert input to account for unmeasured or mismeasured factors.
Regulatory Implications and Future Applications
The application of QBA is particularly relevant as regulatory agencies such as the U.S. Food and Drug Administration, European Medicines Agency, National Institute for Health and Care Excellence, and Canada's Drug Agency continue to support the use of external control arms in evidence submissions.
"By addressing a longstanding gap in the way we evaluate treatments using real-world data, this work brings us closer to making faster, evidence-based decisions in areas where patients often cannot wait for traditional trials," said Alind Gupta. "It also lays the foundation for how SynoGraph can support the next generation of real-world studies with greater methodological integrity."
Onco-Innovations and Inka Health intend to integrate this capability into Inka's SynoGraph platform, enhancing its ability to support pharmaceutical partners in optimizing real-world evidence strategies and advancing access to innovative treatments in settings where traditional trials remain challenging.
The company's approach has the potential to impact not only Onco-Innovation's cancer research but also the broader healthcare landscape by providing a scalable, data-driven solution to the challenges of studying rare and hard-to-treat cancers. As regulatory bodies increasingly turn to real-world evidence in evaluating new treatments, these methodological advances offer a more reliable foundation for clinical decision-making and regulatory assessment.
