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Flatiron Health redefines real-world evidence: Pioneering scientific innovations move beyond 'what is' to uncover 'why' and predict 'what will be'

Published

October 2025

Company announces first-of-their-kind advances in LLM-extracted progression data, data quality frameworks, and harmonized multinational datasets transform cancer research capabilities.

Flatiron Health today unveiled new scientific innovations that have the opportunity to fundamentally redefine real-world evidence in oncology. With the release of their LLM-extracted real-world progression at unprecedented scale, the industry's most rigorous AI data quality framework, and harmonized multinational real-world datasets that enable truly global cancer research, the company has launched advancements that move beyond traditional descriptive analytics to uncover the "why" behind clinical decisions, and predict the "what will be" of patient outcomes.

These innovations support Flatiron's vision of building the world's most comprehensive oncology dataset, now encompassing more than five million patient records and 1.5 billion datapoints available for research, figures that will continue to grow dramatically as the company expands their global data network, scales technology, and deepens global partnerships. These innovations have also addressed limitations that have constrained cancer research for decades: the labor-intensive nature of progression abstraction, the lack of standardized quality frameworks for data, and the impossibility of harmonizing fragmented healthcare data across borders. Together, these capabilities unlock new research questions and enable predictive modeling that addresses the ‘why’ and ‘what will be’ needed to shift cancer research from reactive analysis to proactive insight generation.

“While the industry talks about the potential of AI in healthcare, we're delivering the reality,” said Nathan Hubbard, Chief Executive Officer at Flatiron Health. “These aren't incremental improvements—they're foundational innovations that redefine what's possible in cancer research. We're not just describing what happened; we're predicting what's next and explaining why it matters. This positions our life sciences partners to answer the questions they'll be asking in years to come with the innovations we're delivering today."

Flatiron’s ability to extract real-world progression for patients across all major solid tumors addresses one of oncology's most critical data challenges. Progression is an essential event to understanding a cancer patient's journey, yet has been prohibitively time-consuming and laborious to abstract at scale. Using large language models, Flatiron has unlocked real-world progression at a scale not previously available, enabling researchers to answer entirely new categories of questions about treatment effectiveness and patient outcomes across tumor types including but not limited to lung, breast, ovarian, and prostate cancers.

The company's Validation of Accuracy for LLM/ML-Extracted Information and Data (VALID) Framework establishes the industry's first comprehensive approach to evaluating AI-extracted real-world data quality. This rigorous framework examines performance metrics, data usability, and the ability to replicate expected findings, with a key component being benchmarking performance against expert human abstraction. The framework ensures that AI-extracted insights meet the gold standard required for regulatory and clinical decision-making.

Flatiron's harmonized multinational real-world datasets solve the previously "impossible problem" of cross-border data integration. By harmonizing data across the UK, Germany, Japan, and other markets—and enabling secure access to patient-level data at scale via Flatiron’s Trusted Research Environment (Powered by Lifebit CloudOS)—the company enables multi-country analysis, while maintaining local data control and compliance.

“Flatiron’s scientific innovation is built on the strength of our proven methodological expertise,” said Michael Bierl, VP and Head of Evidence Solutions at Flatiron Health. “Our global evidence generation team of research oncologists, biostatisticians, epidemiologists, and regulatory specialists support partners from study design through analysis, applying validated methods that generate robust evidence to accelerate therapeutic development and improve the way cancer is treated around the world.”

The company continues to serve as an active thought partner to life sciences customers, developing solutions that anticipate and answer their next critical research questions before they know to ask them. Flatiron will be presenting research demonstrating these capabilities at upcoming major oncology conferences, showcasing how understanding the "why" and predicting the "what will be" is already transforming approaches to cancer care and research.

For more information about Flatiron Health's scientific innovations and real-world evidence capabilities, visit https://flatiron.com/real-world-evidence or join us at one of our upcoming events.

About Flatiron Health

Flatiron Health is a healthtech company expanding the possibilities for point of care solutions in oncology and using data for good to power smarter care for every person with cancer. Through machine learning and AI, real-world evidence, and breakthroughs in clinical trials, we continue to transform patients’ real-life experiences into knowledge and create a more modern, connected oncology ecosystem. Flatiron Health is an independent affiliate of the Roche Group.

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