An Introduction to Real World Evidence in Clinical Trials [Video]

Learn how real-world evidence supports modern drug development by analysing data from routine care to answer defined clinical or regulatory questions. We clarify the difference between real-world data and the evidence it enables, and why it complements rather than replaces randomised trials.

In this explainer, we show where real-world evidence adds value across the lifecycle: sizing populations and feasibility in early development, informing endpoints and eligibility for pivotal planning, enabling pragmatic or hybrid trials through health record linkage, and monitoring safety and effectiveness after approval. We outline core principles for credible studies: plan with a prespecified protocol, emulate the target trial, and use suitable methods to address confounding and missing data. You’ll hear how propensity scores, matching or weighting, and transparent diagnostics improve reliability, and why external control cohorts require strict clinical comparability and robust data curation. We also cover practical foundations for data fitness and governance: provenance, completeness, traceability, versioned code, audit trails, privacy by design, secure linkage, and clear cross-border arrangements.

At Quanticate, our biometrics teams help sponsors design, run, and analyse real-world evidence programmes that are reproducible, compliant, and inspection ready. Submit an RFI today.