Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU

The Commission published yesterday guidance to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic.

Aim

The aim is to mitigate the disruption of clinical research in Europe and therefore the negative effects of the pandemic, without compromising on quality and safety. These recommendations are an important part of the overall strategy in finding treatments and a vaccine to protect citizens against the coronavirus.

With more than 200 coronavirus clinical trials now registered in the EU database (EudraCT), the guidance offers recommendations for simple and flexible measures to respond to the current situation, and to ensure that patients participating in clinical trials across the EU can continue receiving their medicines.

Key recommendations

Key recommendations of the guidance cover:

• Distribution of medicines to patients in clinical trials
• Remote source data verification (SDV)
• Communication to authorities

These measures will be used exclusively during the coronavirus pandemic, and will be revoked once the current health crisis in the EU/EEA has been surpassed.

More information

Press release – European Commission