On behalf of Staburo, Josef Höfler and our former colleague Nicole Krämer submitted comments on the EMA’s draft guidance on “Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials”.
The guidance, set up by the Biostatistics Working Party, 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.
