UK coronavirus guidance for clinical trials

The MHRA has provided the following guidance:

• All coronavirus-related protocol deviations must be documented.
• An increase in protocol deviations as a result of coronavirus does not needed to be reported to the MHRA, unless patients are at risk.
• Critical activities such as safety reporting should be prioritised.
• A risk assessment should be carried out and documented for any changes to oversight mechanisms that need to be introduced as a result of coronavirus, such as replacing appointments with phone calls to patients to check their safety and well-being.
• Where enrollment is ongoing, waivers to the eligibility criteria due to difficulties carrying out assessments and tests are not permitted.
• If the safety of a trial participant is at risk because they cannot complete key evaluations, discontinuation of that participant needs to be considered.
• Any temporary halt to a trial as a result of coronavirus must be submitted to the MHRA as a substantial amendment.
• Sponsors of trials involving immunosuppressants should consider the risk/benefit carefully, particularly in the case of healthy volunteer trials.

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