The Medicines and Healthcare products Regulatory Agency (MHRA) have now released guidance on how investigators and sponsors should manage clinical trials during COVID-19.
“The MHRA will be as flexible and pragmatic as possible with regard to regulatory requirements for clinical trials” during the coronavirus outbreak. This is because resources may be disrupted and moved towards front-line care, but the safety of trial participants should be the priority and focus.
The guidance outlines scenarios in which the MHRA must be notified if a trial is halted. The trial master file should include a note as to why the trial was halted. If restarting a study does not involve any substantial changes to the Clinical Trial Authorisation (CTA), then a substantial amendment notification is not necessary. However, any change affecting participant safety should be submitted as a substantial amendment as per normal.
A substantial amendment is not necessary if an investigational medicinal product (IMP) has to be delivered to a patient’s home as they cannot attend the site, although an appropriate risk-assessment and record should be made. Participants must consent verbally, with considerations to be taken for administration training, storage, medicine accountability and documentation requirements.
The guidance also states that the MHRA is supporting remote monitoring for trials where appropriate, as long as the necessary consent and confidentiality issues are addressed. Using phone calls instead of in-person visits and reductions in the number of visits will also be acceptable, not requiring a substantial amendment application. If this is the case, increased focus will need to be added to timely reporting of suspected unexpected serious adverse reactions (SUSARs), which could adversely affect participant safety in the trial.
To view the MHRA guidance on how to manage current clinical trials during the pandemic, click here.
The MHRA is prepared to prioritise assistance for clinical trial applications for COVID-19 related treatments. They have a procedure for rapid scientific advice, reviews and approvals, and are ready to support investigators and sponsors, as they did with the Ebola crisis.
COVID-19 applications should be submitted to the Clinical Trial Helpline by emailing email@example.com, alongside the normal CESP route. It is critical to ensure that the World Health Organisation’s (WHO) official coronavirus acronym (COVID-19) is entered into the title field of the trial registration data set Annex 1 XML, to augment finding and extracting COVID-19 related trials from databases.
For advice on any aspect of COVID-19 related clinical trials, click here.
The European Medicines Agency (EMA) aligns with the MHRA in their guidance on managing and prioritising clinical trials during COVID-19.