The novel framework is designed to help accelerate clinical development through more efficient and informative early-stage trials

Ontada^®, a leader in real-world oncology data and insights, will present new research findings in an oral presentation at the ISPOR Europe 2025 conference, being held this week in Glasgow, Scotland. ISPOR is the leading professional society for health economics and outcomes research globally. The study, titled, "A Framework for Accelerating Clinical Development with Real-World External Control Arms (ECA) in Phase 2 Trials," addresses a critical gap in early-stage clinical research by offering a scalable approach to contextualizing single-arm trial data.

This research highlights the potential of ECAs to enhance Phase 2 trials, which often lack traditional control groups and face challenges related to small sample sizes and slow patient accrual, particularly in oncology and rare diseases.

Key Data Findings

• Real-world data (RWD) curation: The framework outlines a systematic approach to identifying and curating structured and unstructured RWD sources to build robust ECAs.
• Trial emulation: It applies rigorous eligibility criteria from the trial to real-world cohorts, ensuring comparability.
• Adaptive matching strategies: To address limited trial sample sizes, the framework uses simulation techniques to create synthetic datasets that support more robust patient matching.
• Pilot application: The framework was successfully applied to a Phase 2 single arm trial of Tucatinib and Doxil in HER2+ metastatic breast cancer, demonstrating feasibility and value.

“Phase 2 trials are essential for identifying promising therapies, but their inherent design poses challenges to achieving rapid and robust inferences,” said Jessica K. Paulus, ScD, vice president, Real World Research, Ontada. “This framework leverages high-quality real-world data and extends state-of-the-science methods in ECA development to overcome barriers in Phase 2 trial conduct, offering a practical path to accelerate development while maintaining scientific rigor. It’s a meaningful step toward more efficient clinical research.”

Study Methodology

The framework was developed through a literature review of best practices in Phase 3 ECA design and adapted for Phase 2 single-arm trials. It incorporates simulation-based matching to address the challenge of limited trial patient data and was piloted using real-world data for a newly launched Phase 2 trial in HER2+ metastatic breast cancer.

Research at ISPOR Europe 2025

Ontada is showcasing its research capabilities at ISPOR with five accepted abstracts on topics such as evolving trends in patient demographics and diagnosis in gastric cancer, improving data quality in oncology electronic health record-derived databases, assessing secular trends in ovarian cancer diagnoses, and real-world associations between smoking status and genetic driver mutations in metastatic lung cancer. For a complete list of Ontada presentations, visit Ontada’s ISPOR Europe 2025 site. Additionally, visit Ontada at booth #616 at the Scottish Event Campus in Glasgow, November 10–12, to explore our latest research and real-world oncology solutions.

“At Ontada, we are committed to advancing oncology research through innovative applications of real-world data,” said Christine Davis, president, Ontada. “Our presence at ISPOR Europe reflects the depth and diversity of our real-world research capabilities. From advancing trial design with external control arms to uncovering trends in cancer diagnosis and treatment, our work is helping shape the future of oncology through data-driven insights.”

Ontada is a part of McKesson, which has an unmatched portfolio of oncology and multispecialty solutions and partners that provide research, insights, technologies and services that help to address barriers and improve cancer and multispecialty care.

About Ontada^®

Ontada is an oncology technology and insights business dedicated to transforming the fight against cancer. Part of McKesson Corporation, Ontada was founded on the core belief that precise insights — delivered exactly at the point of need — can save more patients’ lives. We connect the full patient journey by combining technologies used by The US Oncology Network and other community oncology providers with real-world data and research relied on by all top 15 global life sciences companies. Our work helps accelerate innovation and powers the future of cancer care. For more information, visit Ontada.com.

About McKesson Oncology & Multispecialty

Our Oncology & Multispecialty segment delivers a portfolio of integrated solutions that support patient care by accelerating drug development, expanding access to high-quality care close to home and ensuring life-saving therapies reach the patients who need them most. We provide practice management, technology solutions, specialty drug distribution, clinical trial and group purchasing services, along with pharmacy solutions for community-based oncology practices and multispecialty providers in retina and ophthalmology. We partner behind the scenes with healthcare providers in local communities, supporting their operations so that they can stay focused on who matters most – patients.

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