How life sciences use real-world data for external control arms today and what’s next

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How life sciences companies are using RWD for external control arms today and what it means for the future

Recruitment delays, ethical concerns and limited sample sizes can stall oncology trials. Researchers are turning to external control arms (ECAs) built with real-world data (RWD) to address these challenges and strengthen evidence generation.

In our latest white paper, “How life sciences companies are using RWD for external control arms today and what it means for the future,” we explore how these methods are moving from theory to practice.

Consider a recent phase II trial in HER2+ metastatic breast cancer. Using RWD for an ECA, researchers achieved covariate balance without a traditional control group, speeding trial design and providing meaningful comparative context. These methods are already helping teams shorten timelines and improve feasibility in rare cancers.

What you’ll find in the white paper

Case studies showing concordance between real-world and clinical trial endpoints
FDA guidance and examples of approvals supported by ECAs
Practical applications for accelerating trials and improving feasibility in rare cancers

RWD is reshaping how research teams design studies and evaluate treatment effectiveness. This paper offers evidence and examples you can apply to your own work.

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