EMA: Points to consider on implications of COVID-19 on methodological aspects of ongoing clinical trials
The European Medicine Agency (EMA) released a guidance to illustrate some points to consider on implications of COVID-19 on methodological aspects of ongoing clinical trials.
“At this point in time it is not possible to provide general advice on how the different aspects related to the COVID-19 pandemic should be handled, as implications on clinical trials are expected to be manifold. Impact on recruitment, data collection, analysis and interpretation of results for each trial will need a thorough case-by-case assessment.–Safety of study participantsis paramount and must be at the heart of every decision taken, regardless of anypotential consequences for an ongoing trial. Beyond this, it is an ethical mandate to proceed with a trial that has been started so that the efforts taken by study participants and physicians can benefit drug development and inform patient care.”
For more details, please see the original document from EMA.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
