In my work as a clinician, I've spent nearly two decades watching the same pattern repeat itself: the treatments that earn approval through randomised controlled trials, our gold standard for evidence, are often tested on populations that don't look like the patients sitting in my clinic. The gap between what clinical trials demonstrate and what I observe in clinical practice isn't merely theoretical—it's reflected in patients sitting in our clinics—and this is precisely where real-world evidence becomes not just valuable but essential.
What RWE Actually Reveals
Rather than replacing trial evidence, real-world evidence complements it by showing us what actually happens when treatments are used outside the controlled environment of a clinical trial, with real patients and all their inherent complexity. What truly excites me most about Flatiron's approach is something more transformative: our ability to connect interoperable global real-world data in ways that enable clinicians in our global site network, biopharma partners and regulators to answer entirely new types of questions about how treatments actually perform across diverse patient populations and care contexts.
When our partners can trace a patient's complete clinical journey across healthcare systems, geographies, and treatment lines—understanding not just isolated outcomes but the cumulative arc of diagnosis, treatment, response, and long-term impact—they unlock the potential to create intelligence that goes far beyond traditional measures. Yet what's equally powerful is how we understand these treatment sequences themselves. Through work like our systematic approach to operationalizing Lines of Therapy across geographies, we've learned that treatment context—what constitutes "current standard of care", how patients progress through sequential therapies, which treatments are appropriate within a line versus signaling a new treatment approach—varies significantly by country and healthcare system.
This allows our partners to see how treatments interact with real disease progression, understand which patient sub-populations derive the most clinical benefit, identify patterns in treatment sequencing and how physicians reason about therapy selection across different healthcare systems and geographies, and ultimately make decisions informed by the genuine complexity of how oncology actually unfolds in practice.
Why Local Data Matters More Than You Think
RWE's true value emerges when it reflects local clinical context, capturing not merely data but clinical understanding that speaks to how treatments work in specific settings for specific populations. When we ground our data in local clinical knowledge, we answer the questions that actually matter to clinicians, regulators, and patients.
This global perspective matters enormously, because it transforms how one can approach evidence generation across their product lifecycle. Flatiron has spent considerable effort and care building interoperable global oncology data in the UK, Germany, and Japan—including our recently launched global prostate Panoramic dataset.
Through partnerships with regulatory and HTA bodies, we've demonstrated how high-quality, interoperable real-world evidence strengthens regulatory decision-making by providing robust data on treatment effectiveness, safety, and outcomes across diverse patient populations and healthcare contexts. Interoperable global data enables the ability to ask strategic questions earlier and more comprehensively—understanding disease epidemiology across markets, identifying optimal patient populations, and gathering evidence in multiple geographies simultaneously while maintaining local clinical relevance. The ability to capture full longitudinal patient journeys across different healthcare systems creates a foundation for evidence that's both locally relevant and globally robust.
Demonstrated Success in Prostate Cancer
Globally, prostate cancer affects nearly 1.5 million patients annually and has a rapidly evolving treatment landscape; yet critical evidence gaps remain, as we see significant regional variation in how novel therapies are used, and in how uneven access to advanced diagnostics differentially influences treatment decisions. Recently, Flatiron built on our already available offerings in this indication to include our first Panoramic datasets in the UK and Germany for patients with prostate cancer. Leveraging proprietary AI and large language model capabilities, our Prostate Panoramic data now encompass the records of nearly 400,000 patients across Germany, the UK, and the US.
The rich data captures local nuance and clinical understanding by providing all Prostate-Specific Membrane Antigen (PSMA) PET scan data, all prostate-specific antigen (PSA) values across the patient journey, and 19 Homologous Recombination Repair (HRR) genes, plus recurrence and progression details, enabling answers to key questions like how novel therapies are being used and which patients are benefiting most. Equally exciting, these datasets are built on a common data model across all regions, enabling unprecedented interoperability—allowing researchers to ask novel, global questions and seamlessly analyse patient outcomes and treatment patterns across markets.
And this data is already translating into research that I see as hugely valuable for improving the standard of clinical care. Most recently, Flatiron teams used this data in the novel research presented at ASCO GU, including:
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A study demonstrating both the need for broader genetic testing in advanced prostate cancer, and the insight that patients with non-BRCA DNA repair mutations experience poorer outcomes than patients with BRCA mutations even when treated with PARP inhibitors—suggesting meaningful biologic differences in treatment response.
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A study revealing a critical need for more effective therapy options following Lu177, a treatment recently approved for metastatic castration-resistant prostate cancer.
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A study demonstrated that nearly half of mCRPC patients remained untested for BRCA, highlighting critical gaps in equitable cancer care and underscoring the urgent need to improve BRCA testing access and awareness across all oncology practices to ensure all eligible patients benefit from personalised medicine.
Building Toward a New Evidence Standard
The momentum behind RWE is undeniable, with regulators increasingly receptive to incorporating real-world evidence in regulatory decision-making, biopharma companies recognising that high-fidelity data creates top-tier evidence generation, and clinicians—those of us with a foot in both the clinic and the data—asking increasingly sophisticated questions about treatment efficacy, sequencing, and applicability. We've moved beyond asking simply "Does this treatment work?" to ask "For whom does it work, under what conditions, in what sequence of care, and what does this mean for my patient population being treated in a clinic in the UK, US, Germany, Japan and beyond?"—questions that require the kind of nuanced and contextual evidence that real-world data can provide.
Flatiron's aims to deliver tailored, impactful solutions that address our clients' evidence needs across the entire biopharma product lifecycle, which requires fundamentally rethinking not just how we collect and process data, but how we approach evidence generation itself and how we connect that data globally to unlock new intelligence. With AI and LLMs increasing the scale of our data and decreasing time to insight, RWE is transitioning from a complementary approach to evidence to something more foundational—the next frontier isn't simply about having more data, but about understanding what connected, longitudinal patient journeys tell us about real outcomes, real treatment patterns, and real impact on care across diverse populations and markets.
This is the work that energises me: bridging the gap between what we know from research and what we need to know for practice. The potential to surface this intelligence derived from our data back to clinicians at the point of care represents a fundamental shift in how evidence informs clinical decision-making in real time, enabling practitioners to understand not just that a treatment works, but when, for whom, under what clinical circumstances it performs best, and what comes next in the patient's journey.
We’ll be presenting our next set of research advancing real-world data for Prostate cancer at ISPOR this May. To learn more about our presence at ISPOR, visit our conference landing page or check out this research deep-dive from my colleague, Eunice Hankinson, "High-quality, validated AI-enabled research: Insights from recent prostate cancer research."
Otherwise, to learn more about Flatiron's approach to real-world evidence and our collaborations on regulatory submissions, visit flatiron.com/real-world-evidence.
