MHRA Updates Guidance for NonCOVID-19 Clinical Trials
Sponsors of nonCOVID-19 trials should assess how trial participants receiving COVID-19 vaccinations could impact their studies, according to updated guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The agency also said protocols for new nonCOVID-19 trials should address whether or how to provide vaccinations to participants in order to avoid substantial protocol amendments in the future.
If a sponsor of an ongoing trial determines the vaccine would have no interaction with the drug being tested, they can inform the agency as part of their trials’ next substantial amendment, labeling it a “nonsubstantial update.”
But in cases where potential issues are identified — such as in trials testing immune-related mechanisms — a substantial amendment to the MHRA and the appropriate research ethics committee approval is required. In such cases, trial protocols must consider if a minimal period of time must separate dosing with the investigational product and administration of the vaccine. MHRA also requires a risk-benefit discussion to support sponsors’ decisions.
In blinded trials, MHRA said sponsors should consider whether their trial subjects would require unblinding in order to receive a COVID-19 vaccine. Although sponsors can unblind subjects on an individual basis, the agency said sponsors should encourage them to remain in the trial. “They should ideally not be withdrawn, unless they explicitly request this,” MHRA said.
Read the updated guidance here: http://bit.ly/3qEVDvp. MHRA said it is working on separate guidance for COVID-19 vaccine trials.