We have written to all Phase I accredited units conducting early phase clinical trials to seek confirmation that all trials have undergone a risk assessment in relation to coronavirus (COVID-19) and the current government advice.

This action will help to ensure the safety of participants and the public, as well as avoid any adverse impact on the capacity of NHS front line services at this very challenging time.

All ongoing clinical trials should have already undergone a risk assessment in relation to COVID-19, including analysis of any potential risk to trial participants, in line with current government advice on social distancing and measures to reduce the spread of COVID-19. This further communication is to facilitate the implementation of government advice to global sponsors of clinical trials through our accredited units.

As a result, some trials may be temporarily halted or terminated, while some will continue if clearly justified, in order to protect or promote public and patient safety.

It is important to stress that this action is not applicable to ongoing or proposed clinical trials related to COVID-19.

Posted on the UK MHRA website on 31 March 2020