Pilot Results on Regulatory-Led RWE Generation

Results from a pilot on regulatory-led RWE generation (co-authored by the European Medicines Agency, EMA) have recently been published in the Clinical Pharmacology & Therapeutics journal.

Key Learnings

The review presents the experience resulting from EMA's pilot to generate RWE to support evaluations by EU regulators from September 2021 to February 2023.

The article highlights the following key learnings:

• Studies using Real-World Data (RWD) can complement evidence from clinical trials and fill evidence gaps during different stages of a product's lifecycle. 
• The need to access additional fit-for-purpose and representative data, and to explore further means to provide timely evidence that meets regulatory timelines.
• The need for early interactions and close collaboration with study requesters, e.g., from the Agency's scientific Committees, to better understand the research question.

Finally, the review shows the agency's perspective on the way forward to maximize the potential of regulatory-led RWE generation. More information is provided in the article on "Real-World Evidence (RWE) to support EU regulatory decision making: results from a pilot regulatory use cases".