Ontada, a leading provider of real-world oncology data and insights, is presenting new research at ISPOR Europe 2025 in Glasgow, Scotland. The study, titled “A Framework for Accelerating Clinical Development with Real-World External Control Arms in Phase 2 Trials,” addresses a key challenge in early-stage clinical research by offering a scalable method to interpret single-arm trial results. The research demonstrates how external control arms can strengthen Phase 2 trials, which often face limited patient numbers and slow enrollment, especially in oncology and rare diseases.
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The study focuses on several core elements of using real-world data effectively. Ontada’s approach begins with the careful curation of both structured and unstructured real-world data sources to construct robust external control arms. It applies strict trial eligibility criteria to real-world patient cohorts to ensure comparability and uses adaptive matching methods to overcome small sample sizes, creating synthetic datasets that allow for better patient alignment. The framework was successfully tested on a Phase 2 single-arm trial evaluating Tucatinib and Doxil in HER2-positive metastatic breast cancer, showing the feasibility and value of this methodology.
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Jessica K. Paulus, ScD, vice president of Real World Research at Ontada, explained, “Phase 2 trials are critical for identifying promising therapies, but their design makes it difficult to generate rapid, reliable conclusions. Our framework uses high-quality real-world data and advanced methods to build external control arms. This helps overcome obstacles in Phase 2 trials and provides a practical way to speed development while maintaining scientific integrity. It represents a meaningful step toward more efficient clinical research.”
The framework was developed through a thorough review of best practices in Phase 3 external control arms and adapted to meet the needs of Phase 2 single-arm trials. Simulation-based matching techniques were incorporated to address limited patient data, and the approach was validated using real-world data from a newly initiated Phase 2 trial in HER2-positive metastatic breast cancer. Ontada is also showcasing additional research at ISPOR Europe 2025, including studies on evolving patient demographics in gastric cancer, improving oncology EHR-derived database quality, tracking trends in ovarian cancer diagnoses, and examining the relationship between smoking and genetic mutations in metastatic lung cancer.
Christine Davis, president of Ontada, stated, “Ontada is dedicated to advancing oncology research by using real-world data in innovative ways. Our presence at ISPOR Europe highlights our capabilities in improving trial design, uncovering cancer care trends, and generating insights that can transform oncology research. These efforts help ensure that high-quality evidence reaches clinicians and patients faster, supporting better outcomes across the oncology community.” Ontada is part of McKesson, leveraging its broad oncology and multispecialty portfolio to provide research, insights, technology, and services aimed at overcoming barriers and enhancing care.
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