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Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1) – our initial response

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The Covid-19 pandemic has been a challenging time for all of us and in this three-part blog series, we reflect on what we have learnt and how we move forward to implement those learnings for the benefit of the UK clinical trials ecosystem and, ultimately, patients.

At the start of the pandemic it was obvious we needed a process to ensure COVID-19 trials were able to be up and running as soon as possible in the interests of public health.  This involved prioritising the processing and reviewing of all applications for COVID-19 therapeutics and vaccines trials. The Medicines and Healthcare products Regulatory Agency (MHRA), assigned dedicated COVID-19 assessors and put in place a process to pre-assess trial documents, so any issues could be highlighted and addressed before the protocol and supporting documentation were finalised and formally submitted for regulatory approval. This greatly reduced the possibility of a rejection, which allowed a much faster approval of trials, whilst maintaining our robust safety standards.  Expert advice on COVID-19 applications was also provided to our Clinical Trials Unit from the Commission on Human Medicines expert working group. This overall approach also ensured there was minimal impact to the approvals process for non-COVID-19 applications.

A dedicated email address was set up and used for any COVID-19 related trials questions and submissions, so these could be easily identified, prioritised and addressed by the dedicated assessment team. We addressed a huge number of queries, not just for COVID-19 trials of course but queries around trials that could not continue or faced other challenges due to the pandemic too. We also offered informal regulatory advice meetings and more formal scientific advice if needed, again supported by the dedicated specialist team of assessors and GCP Inspectors.

During the early stages we worked on any potential regulatory flexibilities and set up regular meetings with industry to raise any issues and discuss potential flexibilities. In fact, for GCP flexibilities we already had many of these in established guidance, such as risk-based monitoring, direct to patient shipment of IMP, electronic consent; but a lot of these were quite underused pre-pandemic.

We managed to be one of the first Regulators in the world to rapidly issue – and continually add to – guidance on applications for trials (both COVID and non-COVID), plus management of trials during the pandemic and we made these publicly available on the MHRA website. Topics covered:

  • remote monitoring,
  • protocol deviations,
  • remote access to electronic health records (EHRs) and instructions around halting trials,
  • guidance on minimising disruptions to the conduct and integrity of clinical trials of medicines during COVID-19.

We collaborated with our wider national and international network in relation to trials and healthcare in general. For example, we were part of a national effort in relation to ensuring supply of IMPs for trials, and the logistics of getting them to trial sites to match recruitment rates. Internationally we were talking to other regulators in relation to the set up and approval of trials, especially in relation to vaccines.

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  1. Comment by Noreen Chaudhry posted on

    Unfortunately the links to further articles in the blog do not work.
    Upon clicking any link, a message states "Sorry, but the page you were trying to view does not exist."