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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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.
EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.