The article “Real-World Evidence (RWE) to Support EU Regulatory Decision Making: Results from a Pilot Regulatory Use Cases,” co-authored by the European Medicines Agency (EMA) and published in Clinical Pharmacology & Therapeutics, highlights the role of real-world data (RWD) in complementing clinical trial evidence and addressing gaps during a medicine’s lifecycle. It reviews EMA’s pilot project from September 2021 to February 2023, which aimed to generate RWE for EU regulatory evaluations. Key takeaways include the importance of accessing high-quality, representative data, ensuring timely evidence aligned with regulatory timelines, and fostering early collaboration with stakeholders. The article also outlines strategies to maximize the impact of regulatory-led RWE in decision-making.1

Continue reading here.

References

  1. Prilla, S., Groeneveld, S., Pacurariu, A., Restrepo‐Méndez, M. C., Verpillat, P., Torre, C., Gartner, C., Mol, P. G. M., Naumann‐Winter, F., Breen, K. C., Gault, N., Gross‐Martirosyan, L., Benchetrit, S., Aylward, B., Stoyanova‐Beninska, V., O’Donovan, M., Straus, S., Kjaer, J., & Arlett, P. (2024). Real‐World Evidence to Support EU Regulatory Decision Making—Results from a pilot of regulatory use cases. Clinical Pharmacology & Therapeutics. https://doi.org/10.1002/cpt.3355

Disclaimers

  • The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred