Explore the growing role of real-world evidence (RWE) in constructing external control arms for clinical trials, especially when traditional randomized controlled trials (RCTs) face practical or ethical constraints. This white paper highlights the complexity of modern trials in fields like oncology and rare diseases, the operational challenges, and how RWE—sourced from electronic health records, patient registries, and claims—provides valuable comparators. The paper also discusses regulatory guidelines, statistical methods for reducing bias, and the importance of partnerships with contract research organizations (CROs).

Download our white paper to discover:

1. How real-world evidence offers an effective alternative for external control arms when RCTs are not feasible
2. When complexity in trials, such as rare diseases and oncology trials, drive RWE adoption
3. Regulatory Support by the FDA and EMA provide guidelines for its appropriate use
4. Why strategic partnerships and collaboration with CROs are essential for successfully integrating RWE into external control arms

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TFS Real-World Evidence