EMA: Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

This guidance covers actions that sponsors of ongoing clinical trials affected by the coronavirus disease (COVID-19) pandemic should take to help ensure the integrity of their studies and interpretation of study results while safeguarding the safety of trial participants as a first priority.

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.

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.

For more information visit EMA website here