The European Commission has published guidance to minimise disruption to research and ensure clinical trials can continue within the EU.
The COVID-19 pandemic is putting pressure on healthcare systems worldwide and capacity is reaching limits in many places across Europe. The European Commission has now published new guidance for clinical trials to ensure the rights, safety and wellbeing of trial participants and the safety of clinical trial staff during the crisis.
The guidance aims to alleviate the negative effects of the COVID-19 pandemic without compromising quality and safety, are an important part of the overall strategy in finding treatments and a vaccine to protect citizens against the coronavirus outbreak.
Currently, more than 200 coronavirus clinical trials are registered in the EU database (EudraCT). The new 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.
Some of the key recommendations in the guidance include:
- Distribution of medicines to patients in clinical trials: the purpose is to protect the safety and well-being of trial participants and the integrity of the clinical trials. This recommendation considers social distancing measures and possible limitations in trial site/hospital resources.
- Remote source data verification (SDV): the verification of the raw data in hospitals can become extremely difficult during the pandemic due to safety measures, such as social distancing. Remote SDV to conclude a trial could facilitate the marketing authorisation of coronavirus and life-saving medicines.
- Communication to authorities: urgent actions to protect trial participants against any immediate hazard or other changes with an effect on patient safety or data robustness might become necessary to mitigate disruptions during the ongoing public health crisis. The guidance clarifies the classification and notification of these actions.
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.
Commissioner Stella Kyriakides, in charge of Health and Food Safety, said: “We are in the midst of the worst pandemic in recent memory and it is absolutely crucial that we show flexibility in our rules to maintain research on critical treatments, including chronic and rare diseases, through clinical trials. Developing and deploying effective diagnostics, treatments and a vaccine will also undoubtedly be the most important breakthrough to stop the coronavirus.
“On 4 May, our international pledging conference will kick-start global cooperation and support for this work, with the aim to raise €7.5bn in funding to the benefit of the global community. Together in solidarity, we will prevail.”