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