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 Real-World Evidence (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 of regulatory use cases".
Related GMP News
05.12.2024ICH E6(R3) Annex 2 Draft Guideline Released
05.12.2024ICH M15 Draft Guideline on Model-Informed Drug Development
07.11.2024Interim-Report on EMA's Clinical Study Data Proof-of-Concept Pilot
07.11.2024FDA Issues Guidances to Support Clinical Trial Innovation
17.10.2024FDA's final Q&A Document on Electronic Systems & Data in Clinical Trials
17.10.2024EMA Guideline on Quality and Equivalence of Topical Products