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EU issues advice for clinical trials during Covid-19 pandemic

Member states asked to slow recruitment of participants and postpone visits

European medical regulators and clinical practice advisers have published guidelines for running clinical trials during the Covid-19 pandemic, in an effort to “mitigate and slow down the disruption of clinical research in Europe during the public health crisis”.

The guidelines, published on 28 April, acknowledge that “extraordinary measures may need to be implemented and trials adjusted due…to trial participants being in self-isolation or quarantine, limited access to public places (including hospitals) due to the risk of spreading infection, and healthcare professionals being committed to critical tasks”.

They say that “pragmatic and harmonised actions are required to ensure the necessary flexibility and procedural simplifications needed to maintain the integrity of the trials, to ensure the rights, safety and wellbeing of trial participants and the safety of clinical trial staff during this global public health crisis”.

EU member states are therefore encouraged to adopt, for the duration of the crisis, measures such as slowing recruitment of trial participants, postponing in-person visits to participants or instead contacting participants remotely, temporarily halting activity at trial sites and extending end dates for some trials. They are also asked to “critically assess” the need to start new trials.

“The safety of the trial participants is of primary importance, and risks of involvement in the trial, in particular with added challenges due to Covid-19, should be weighed against anticipated benefit for the trial participants and society,” the guidelines say.

The European Federation of Pharmaceutical Industries and Associations welcomed the guidance, saying its own “overarching request” to regulators in the EU member states was “to continue to seek alignment across all EU countries on the necessary flexibilities for the conduct of clinical trials and the means to manage data integrity”.