EMA offers methodological considerations for trials during Covid-19 pandemic
The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline on points that clinical trial sponsors should consider on the implications of the coronavirus disease (Covid-19) on methodological aspects of ongoing trials.
While noting that “it is not possible to give general applicable advice on how the different aspects related to the pandemic should be handled, as implications on clinical trials are expected to be manifold,” the EMA’s Biostatistics Working Party calls on sponsors “to pre-plan how systematic deviations resulting from the measures and individual decisions related to the Covid-19 pandemic are captured,” as well as to record such deviations and the related reasons for them.
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