MHRA Timelines Back on Track

The UK has always been one of the top countries in the world for scientific research and development in the life science and health sectors. Amazing research facilities, an academic sector and NHS that integrated well with clinical trials and an engaged population meant that that the UK punched above its weight. When the pandemic hit with an urgent need for vaccines to be developed, the UK shone like a beacon of hope.

However, commercially driven clinical trials were already in decline, with the ABPI reporting a signification reduction (41%) between 2017/18 and 2020/21, particularly in Phase II and Phase III trials. 

Of course, 2020 was when the global COVID pandemic struck, so it’s probably not surprising that the number of clinical trials and the corresponding recruitment numbers were going to drop. 

Interestingly though, Phase I trials, whilst seeing a slight dip in trial numbers over the same period, by 2021 were showing early signs of recovery. But still, Phases II and III were in the doldrums which was compounded by the hard focus on streamlining efforts and ensuring the COVID vaccine trials were a priority. This meant that anything non-urgent was parked until it was deemed safer to do so leading to a backlog of applications waiting for approval. 

In the meantime, other countries around the world saw an opportunity to increase approvals of clinicals trials or have been able to attract larger numbers of volunteers for their Phase II and Phase III studies.

In February 2023, the UK government was spurred into action and commissioned a review of the situation. Based on the findings of his review, Lord O’Shaughnessy identified a number of improvement actions the UK should take to help put us back on track. Many of the recommendations focus late stage clinical trials and those involving NHS and non-commercial organisations but some recommendations are just as important for those entering Phase I, including:

• Reducing regulatory burden of approval trials and removing set-up delays
• Get back to a 60 day turnaround goal for all clinical trial approvals 
• Reduce time from trial approval to first patient first visit 
• Rebuild MHRA capacity and expertise in clinical trials

UK Still Top 5 for Phase I Clinical Trials

The O’Shaughnessy report paints a pretty glib picture, but provides some really constructive and very tangible recommendations that will help pull the UK back up the Phase II and Phase III rankings. 

The good news is the UK’s top 5 ranking for Phase I trials remains and that since the report was published, the UK has implemented or is implementing many of the recommendations and they are already starting to have an impact. The UK has started to see an up-tick in clinical trial activity.

And for those Sponsors preparing to bring their drug candidates into the clinical for the first time, this should be music to their ears because these improvements apply across all phases.

In a recent interview with publication New Scientist, Professor Andrea Manfrin, the MHRA’s Deputy Director of Clinical Investigations and Trials said that the MHRA have been working hard on turning things around, “redesigning the clinical trial environment in the UK” and aiming to be an ‘agile regulator’. Faster and more streamlined approvals and greater capacity at the MHRA to support this as well as the structural and bureaucratic improvements can only be a good thing. 

Professor Manfrin goes on to say, “We are working to enable activity, commercial and non-commercial”

With average timelines closer or in some cases shorter than the 60 days the MHRA has pledged, the UK is now a far more attractive option. 

What’s more, the MHRA have a voluntary scheme where clinical trial units (CTUs) can become accredited to deliver Phase I, particularly first-in-human clinical trials. The CTUs on the scheme (of which there are currently 13) are accredited because they have gone above and beyond basic good clinical practice (GCP) and have additional procedures to ensure volunteer safety.

At The Science Behind, we are proud to be a trusted partner with two (soon to be three) MHRA-accredited Phase I Clinical Trial Units (CTUs). Our specialised neuroscience services seamlessly integrate with these elite CTUs, providing Sponsors with a cost-effective and comprehensive approach to Phase I trials. By leveraging our expertise, we not only assist in providing early indications of efficacy but also rigorously ensure safety and tolerability. As the UK’s clinical trial landscape rejuvenates, our commitment to excellence and innovation allows us to deliver bespoke services in the ever-evolving world of clinical research. With our support, Sponsors can navigate this revitalised landscape with confidence, knowing they are partnering with experts in the field.