Five RWE Approaches That Strengthen Precision Oncology

By Katja Hakkarainen, PhD, Vice President & Global Head of Epidemiology, Real World Research

In precision oncology, better evidence isn’t just helpful—it’s a competitive advantage. As treatments become more targeted and patient populations more defined, sponsors need richer data to demonstrate value and drive confident decision‑making. Real‑world evidence (RWE) is rapidly emerging as a powerful complement to traditional clinical trials, revealing how therapies perform in routine care and expanding insights beyond controlled research environments.

This article outlines five high‑impact ways sponsors can leverage RWE to strengthen precision oncology programs. It explores how real‑world data can refine trial design and eligibility criteria, inform biomarker strategy, and enhance regulatory submissions with contextual evidence. It also highlights how RWE can demonstrate clinical and economic value to payers and health systems, helping accelerate access and reimbursement. Additionally, RWE provides critical insights into outcomes in rare biomarker-defined populations where traditional studies may be limited by sample size or feasibility.

By integrating RWE early and strategically, sponsors can sharpen development choices, reduce uncertainty, and speed the path to innovative cancer therapies. When backed by robust data quality and scientific rigor, RWE becomes a catalyst for more agile, insight‑rich precision oncology development.