EU Allows More Flexibility In Managing Trials During COVID-19
Guidance Explains How Medicines Can Be Distributed To Participants
The EU has issued revised guidance to ensure that clinical trials can continue taking place during the COVID-19 pandemic.
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With major disruptions to clinical trials becoming more commonplace due to political conflicts and natural disasters, the European Medicines Agency has developed guidance to help sponsors make risk-based adjustments to manage ongoing studies.
Participants in a recent webinar looked at how the coronavirus is changing the way we look at clinical trials and whether new EU COVID-19 guidance might hold lessons for future approaches to study design.
New EU guidance on managing clinical trials in the context of COVID-19 requires sponsors to critically assess the feasibility of starting a new clinical trial or including new participants in an ongoing trial. A separate survey indicates that patient willingness to participate in new trials has dramatically declined due to the pandemic.