As we’ve reported previously, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), as the regulator of medicines, medical devices and blood components in the UK, has been active in attempting to mitigate the impact of coronavirus by taking steps to lessen the regulatory burden on companies working on issues central to the fight against COVID-19.

In this vein, it has stated it will be particularly flexible and pragmatic in authorising clinical trials connected to COVID-19, referring to its previous track record of having acted swiftly in past public health crises (e.g. it authorised clinical trials within a week during the Ebola crisis). Most recently, the COVID-19 Oxford Vaccine Trial received approval within 7 working days of application. The regulator has indicated that it is willing to offer advice and is aiming to complete the review and approval process of clinical trials within a week. To that end, the MHRA has, amongst other things:

  • Prioritised all COVID-19 related queries, and required the use of ‘COVID-19’ in any emails to help them triage issues accordingly
  • Established principles for managing trials in the current climate of social distancing, and guidance for when the MHRA does and does not need to be contacted in respect of changes to clinical trials, to reduce the regulatory uplift of impacted companies:
  • Ongoing trials impacted by COVID-19: There is no need to inform the MHRA if a trial is temporarily suspended for reasons related to COVID-19 unless there is ‘a direct participant safety issue’ or ‘medicines supply issue’
  • Participants unable to attend trials due to COVID-19: A risk assessment must be completed and internal records updated where a participant cannot attend a trial site and consents to have medicine shipped medicine to their homes
  • Remote supervision: Remote monitoring of trials (with the consent of participants in relation to the use of their data off-site) and telephone calls is permissible in place of in-person visits
  • Remote participation: Participant monitoring visits can be reduced with appropriate risk assessments and where the rationale for doing so is thoroughly documented
  • Disruption to supply chains during trials: MHRA should be notified if a supply issue results in a risk to participant safety or impacts other participants in the trial. A report to the MHRA should be made as soon as possible once capacity issues are resolved also
  • Protocol deviations are possible: Increased deviations from agreed upon clinical trials protocols will not automatically result in a regulatory breach as long as they are well documented
  • Complete rejection of protocol waivers: Protocol waivers are not permissible. Patients must continue to meet eligibility requirements for clinical trials
  • Maintaining ‘social distancing’: Direct contact can be limited – e.g. through alternative email rather than in-person signing of documents for confirmation of participation in a trial

Overall, whilst the MHRA have been willing to adopt the above flexibilities, they have been very clear in noting that any flexibility cannot be at the expense of the safety of participants in clinical trials.

As noted in our previous article, adherence to the clearly-defined exemptions granted by authorities, including the MHRA, therefore remains key to mitigating risk. Notwithstanding the above guidance noting instances where the MHRA need not be informed of issues, companies should continue to exercise discretion when dealing with issues that could have an impact on safety based on expertise.

 

Posted by Sarah-Jane Dobson

International products lawyer, Cooley LLP