Summary and Key References

This module traced Real-World Evidence from its foundational purpose — filling the safety-data gaps clinical trials leave behind by structural necessity — through the full methodological toolkit that makes RWE rigorous rather than merely plausible: seven distinct RWD source types each suited to different questions, six pharmacoepidemiology study designs each solving a different methodological problem, confounding as the fundamental limitation no analysis fully escapes, OMOP as the standardisation layer making multi-database work possible, and the global federated networks actually running this infrastructure today, India’s included.

The throughline connecting every lesson back to the rest of this course was the triangulation principle Lesson 15.9 built directly: a signal detected through Module 7’s disproportionality analysis becomes genuinely confirmed and actionable specifically when independent evidence streams — spontaneous reports, published literature, and a properly designed RWE study — converge on the same conclusion. Neither spontaneous reporting nor RWE alone typically settles a genuine safety question; the discipline this module taught is knowing how each contributes, and how to combine them credibly.

Key references: PV360 Handbook Ch.15, OHDSI/OMOP Common Data Model documentation, EMA DARWIN EU governance documentation, FDA Real-World Evidence Framework (2024), FDA Sentinel/Sentinel NextGen documentation, India’s Digital Personal Data Protection Act 2023, CDSCO PvPI Guidelines 2024.