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Warning that life-saving research is being put on hold due to delays that have seen trials for cancer drugs take 6 MONTHS longer to begin
- EXCLUSIVE: UK drug watchdog’s approval process has tripled since summer
- Studies affected include ones conducted by the NHS, universities and pharma
Life-saving research is on hold due to a three-month backlog in approving medical trials, metronidazole gel 75 for acne MailOnline can reveal.
Any study involving giving humans drugs must be signed off by the Medicines and Healthcare products Regulatory Agency (MHRA).
These can include testing new medications and vaccines for the UK’s biggest killers, such as dementia, cancer and heart disease.
However, the watchdog’s approval process — which is supposed to take a maximum of 30 days — has tripled to three months since the summer.
Some have even been put on ice for six months, this website can reveal.
Under the MHRA’s own rules, it should finish assessing all applications within a 30 days, or within 10 days after its has received any final information. But official figures show that average weights have surged from 31 days in June 2022 to 92 days in April
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for signing off on all studies that involve giving participants drugs. These can include testing new drugs and vaccines for the UK’s biggest killers, such as dementia, cancer and heart disease
Studies affected include ones conducted by the NHS, universities and pharma giants, some of which are backed by millions in funding.
Researchers have warned the delays mean patients face longer waits to receive any potentially life-saving treatments.
MHRA bosses have blamed delays on a lack of staff and spike in demand.
It has already been given an extra £10million from the Government, in part to deal with the problem. The cash, confirmed in March, was allocated to make medical products developed in the UK available more quickly.
Critics say the backlog is denting ambitions for Britain to become a science superpower.
The MHRA regulates clinical trials carried out in the UK, which are at the heart of the development of new therapies. For instance, it had to approve Covid jab and drug trials, which were at the heart of the UK’s pandemic response.
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As part of its series of rigorous checks, it ensures all studies meet safety and ethical standards.
Under the MHRA’s own rules, it should finish assessing applications within 30 days of them being submitted, or within 10 days of pharma companies answering any final queries about their project.
But official figures show that average weights have surged from 31 days in June 2022 to 92 days in April.
MHRA chiefs hope the backlog will start to be tackled by September — but have warned the sector to expect delays until then.
Trials add around £2billion to the UK’s economy every year, and give patients early access to cutting-edge treatments. It also sees pharma giants hand millions to the NHS to help with its research, which could otherwise be funded by the taxpayer.
Professor Pamela Kearns, director of the Cancer Research UK Clinical Trials Unit at the University of Birmingham, is running 100 trials across 347 sites in 21 countries, in collaboration with the UK Government, charity and pharma companies.
She told MailOnline that these studies, including childhood cancer trials, are vital to ‘translate cutting edge science and research into improved patient care’.
But delays getting clinical trials approved has ‘sadly been a major issue for us in a field where time is of the essence’, Professor Kearns added.
Dr Jennifer Harris, director of research policy at the ABPI, told MailOnline the delays mean that the UK’s position as an ‘attractive destination for global research is under strain like never before’.
On top of the MHRA delays, the number of Brits participating in industry-funded trials has fallen 44 per cent since 2017, from 50,000 to 28,000 a year, she noted.
‘Together, these challenges, alongside wider NHS capacity issues, are preventing patients from getting access to cutting-edge treatments via research,’ she said.
Dr Harris added: ‘We know the Government is aware of these challenges, demonstrated by giving the MHRA an additional £10million to help bring new medicines and technologies to UK patients more quickly in the last budget.
The MHRA is responsible for signing off on all studies that involve giving participants drugs. The graph shows the number of applications it has received per month (blue) and how many it has approved (red)
‘We hope to see further proposals to address the wider challenges facing UK clinical trials soon following a number of independent government reviews.
‘Getting UK clinical trials back on track is an essential piece in the puzzle if the UK is to realise the Prime Minister’s vision of the UK as a life sciences super-power.’
An MHRA spokesperson said: ‘We are aware that industry and researchers are experiencing extended timeframes in their clinical trial applications.
‘Many factors, including increased demand for our services, are leading to these extended timelines.
‘To address this we are taking a number of steps, which include putting more resources on the areas of high demand.
‘We are working quickly to streamline our processes with the aim of increasing both the pace and predictability of our services.
‘We always prioritise applications where there is a risk to patient or public health.
‘We are confident that the measures we have in place will reduce the complexity of getting trials approved and up and running and will importantly get innovative treatments to the people who need them sooner.’
It comes after a major review published last week examined how to improve the environment for running clinical trials in the UK.
Former Health Minister Lord James O’Shaughnessy, who was commissioned by the Government, said complaints about the under-resourced MHRA were among the most common, with its delays being a ‘significant impediment to siting more trials in the UK’.
One global pharma giant warned it had to put-off recruiting for 13 of its trials due to MHRA delays between September 2022 and February 2023.
It also complained of a lack of ‘communication and transparency’ about the MHRA’s backlog and how it is prioritising approvals.
Lord O’Shaughnessy said this makes researchers less confident about launching trials in the UK.
Among his recommendations is for the MHRA to set up a rapid task force to tackle delays and for the Government to allocate it more cash.
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