EMA workshop on primary efficacy endpoints for antivirals and monoclonal antibodies intended for the treatment of COVID-19 and influenza held the 5 June 2025: publication of the video recordings of the event
The workshop was organised to bring together academic, regulatory, industry and healthcare professionals.
It discussed similarities and major challenges experienced with the clinical study design in antiviral treatment trials for COVID-19 and influenza.
It also aimed to identify and discuss feasible and clinically relevant primary efficacy endpoints that can generate robust data to allow the approval of new antivirals or monoclonal antibodies for the treatment of COVID-19 and influenza.
In addition, the workshop intended to shed light on different aspects on pandemic preparedness. These include:
- clinical study designs,
- the importance of pre-approved protocol for clinical trials that can be implemented during a pandemic,
- evidence needed to support public health recommendations and stockpiling of antivirals and monoclonal antibodies.
The video recordings of the event are now available on the EMA Website.
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vroby (20 septembre 2025). EMA workshop on primary efficacy endpoints for antivirals and monoclonal antibodies intended for the treatment of COVID-19 and influenza held the 5 June 2025: publication of the video recordings of the event. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/14pwn





