Here’s a summary of the two articles co-authored by the European Medicines Agency (EMA):

  1. Accelerating Clinical Trials in the EU (ACT EU): The ACT-EU initiative is making significant progress in transforming the EU’s clinical trials landscape. Key achievements include enhancing the Clinical Trials Information System, advancing Clinical Trial Regulation, and publishing important guidance. These efforts are expected to drive innovation in regulatory, technological, and procedural areas, leading to more efficient and effective clinical trials in the EU.
  2. Generating Clinical Evidence for Long COVID: The EMA organized a workshop on November 17, 2023, focusing on generating clinical evidence for the treatment and prevention of long COVID. The workshop emphasized the need for well-designed clinical trials to support regulatory recommendations. Experts agreed that initiating clinical trials promptly is crucial for exploring potential treatments and ensuring patient access to medicines in a safe clinical trial environment.

Read more here. You can read more about the second article here.

References

  1. Capone, G., Eriksson, B., Al, M., Van Belkum, S., Broich, K., Lamas, M., Lunzer, M., Nolan, L., Ester, C., Burgos, J. G., Pioppo, L., Zanoletty, A., & Arlett, P. (2024). Accelerating clinical trials in the EU (ACT EU): transforming the EU clinical trials landscape. Nature Reviews Drug Discovery. https://doi.org/10.1038/d41573-024-00085-5
  2. Buchholz, S., Di Meco, E., Bałkowiec-Iskra, E. Z., Sepodes, B., & Cavaleri, M. (2024). Generating clinical evidence for treatment and prevention options for long COVID. Nature Medicine, 30(8), 2109–2110. https://doi.org/10.1038/s41591-024-03031-5

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