This complements the good clinical practice guidance on how sponsors should adjust the management of clinical trials and participants during the COVID-19 pandemic.
EMA’s Biostatistics Working Party encourages affected clinical trial sponsors to seek scientific advice on these matters.
In line with this guidance, EMA will be flexible and pragmatic during the assessment of affected clinical trial data submitted to the Agency as part of marketing authorisation applications.
The guidance is under a four-week public consultation until 25 April 2020.
Please note that further updates are possible and likely given the rapidly evolving nature of the pandemic.