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Clinical trial ‘High Throughput Centres’ could help UK compete post-Brexit

Proposals come as EU plans major upgrade in trials regulation

London

The UK government is being urged to support the creation of ‘High Throughput Centres’ to accelerate phase 2 and 3 trials in the country, and help it compete in the global clinical research market post-Brexit.

The concept has been put forward in a white paper by clinical trials accrediting company IAOCR and Jonathan Sheffield, chief executive of the UK government-funded NIHR Clinical Research Network.

They say that creating new dedicated centres will help cut regulatory approval times in the UK, and would include establishing a full time professional research ethics committee to speed up ethics scrutiny and approval for clinical trials.

The proposals have come in response to the Life Sciences Industrial Strategy (LSIS) published in August 2017. Among its stated goals was a pledge to increase the number of clinical trials conducted in the UK over the next five years by 50%.

The authors of the white paper cite EudraCT data showing that the UK increased its share of European drugs trials in 2016, accounting for 29% of total EU trials.

This sizeable share of the market will be put at risk by exiting the EU, which is likely to see the UK no longer part of EU clinical trial regulations, though this depends on the final shape of any Brexit deal agreed.

The EU is set to introduce a major update to clinical trials practice in 2019 and 2020 – the Clinical Trials Regulation (CTR).

This could be a major step forward for Europe and accelerate trial approval times: it will harmonise rules for conducting clinical trials throughout the EU and streamline the application process. A new online EU clinical trial portal will allow sponsors of trials involving multiple sites to submit a single application for multiple sites to authorities of all EU Member States.

As the UK looks likely to be partially or completely excluded from this system because of Brexit, the plan for high throughput centres could help maintain the country’s competitiveness.

Jonathan Sheffield

Jonathan Sheffield, chief executive of NIHR Clinical Research Network

“By focusing on collaboration between the clinical research industry and the NHS we can harmonise and improve the clinical research process for both patients and the industry; ultimately working to get new treatments available for patients in a more efficient, but equally robust, way,” says Jonathan Sheffield, chief executive of the NIHR Clinical Research Network.

“The NIHR is actively working to facilitate partnerships between Industry and the NHS; the introduction of High Throughput Centres would extend the work we’ve already begun and accelerate the process to the advantage of those requiring new treatments, as well as the industry.”

The High Throughput Centres would be staffed by NHS clinical professionals dedicated to conducting clinical trials.

“High Throughput Centres just make sense for the international clinical research industry as well as for the UK specifically,” said Jacqueline Johnson North, CEO and co-founder of IAOCR.

She says the centres would allow for greater industry-NHS collaboration, and would help raise awareness of clinical trials in patients, and ultimately help accelerate treatment options and improve outcomes.

Last week the UK's medicines regulator the MHRA put out its own consultation on a post-Brexit regulatory environment where the UK was outside any EU framework. It says that in the 'unlikely event' of a no deal Brexit scenario, it will become a standalone regulator, and would develop "new innovative licensing routes, the possibility of new global partnerships, and a competitive fee structure" in order to maintain the UK's attractiveness.

Read the IAOCR white paper here: High Throughput Clinical Research Centres in the NHS: A report to the UK Government from the clinical research sector.

Article by
Andrew McConaghie

8th October 2018

From: Research

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