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The future regulation of clinical trials

With the UK in the Brexit transition period until the end of the year, regulation of clinical trials is likely to be under discussion in UK-EU negotiations on the future relationship

Management of clinical trials in this country falls under the auspices of the Medicines and Healthcare products Regulatory Agency (MHRA), which must review each trial prior to it taking place.

As an EU member state, trials have also been subject to an EU directive that was transposed into UK law in 2004. This outlines the procedures involved to conduct a trial, including the protection of trial subjects, manufacture and use of investigational treatments and safety reporting.

According to Government guidance that has now been withdrawn, these regulations would still apply as the UK leaves the EU.

But the situation is complicated by the fact that the EU is set to implement a new Clinical Trials Regulation (CTR), which aims to simplify the application process and harmonise the assessment procedure across all EU members.

To this end, a new, electronic portal, known as the Clinical Trials Information System (CTIS), will be created to store data regarding trials centrally and augment the efficiency of their running.

The exact timeframe for when the CTR will formally come into effect remains unclear. For its part, the Government has issued a ‘clear commitment to align where possible with the CTR without delay’.

Yet, the ‘where possible’ inclusion implies that this is not unequivocal. Moreover, the UK’s negotiating tactics, published last month, offered no further clues.

Furthermore, the MHRA has previously inferred that UK participation in the CTIS and single assessment model is not guaranteed and would be subject to negotiations between the UK and EU.

Meanwhile, December’s Queen Speech gave notice of a Medicines and Medical Devices Bill that is currently making its way through Parliament.

Regarding clinical trials, the Bill intends to provide a ‘streamlined, internationally competitive approach’ that would ‘remove unnecessary and duplicative regulatory burdens’, so that new treatments can be introduced more quickly.

The desire to make the UK an appealing location to conduct clinical trials after Brexit is understandable – in a study last year, more than half of American pharma leaders believed that the UK would be a less attractive option, compared with just under a quarter who thought otherwise.

Yet, the possibility of UK-EU divergence on trial regulation could cause problems, such as the recruitment for trials (particularly for less common conditions) and the status of UK patients in multinational EU trials.

In addition, the former Universities and Science Minister, Chris Skidmore, has stressed the reliance of UK trials on association with the EU’s upcoming Horizon Europe research programme – for which there is also uncertainty about the UK’s involvement.

The Brain Tumour Charity is committed to increasing the quantity of, and access to, clinical trials for brain tumour patients. Indeed, we have funded numerous trials, some of which have included collaboration with EU institutions.

Thus, while the provisions in the Medicines and Medical Devices Bill on clinical trials are encouraging, we still call on the Government to have complete alignment with the CTR, including involvement in the CTIS, as this would best serve the interests of our community.