The UK Medicines and Health Care products Regulatory Agency (MHRA) has issued guidance on the management of clinical trials in the context of coronavirus. Trial protocol and standard operating procedure deviations are already starting to occur in the UK as a result of coronavirus. Many of these deviations relate to missed visits due to patients who are infected or in self-isolation, or who have been advised not to, or would prefer not to, attend public places such as hospitals. Changes in trial processes are also becoming necessary as a result of staff involved in running the trial working from home.
The MHRA has provided the following guidance:
As can be seen from the guidance above, the MHRA is taking a pragmatic approach whilst at the same time continuing to prioritise the safety of trial participants.
Authored by Jane Summerfield
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