The UK Medicines and Healthcare 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:
- 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.
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