Warning that life-saving research is being put on hold due to delays
Lifesaving research has been suspended due to a three-month backlog in approving medical trials, MailOnline can reveal.
Any research involving the administration of drugs to humans must be approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
These include testing new drugs and vaccines for the UK’s biggest killers, such as dementia, cancer and heart disease.
However, the watchdog approval process — which was supposed to take up to 30 days — has tripled to three months since the summer.
Some have even been put on hold for six months, this website can reveal.
Under the MHRA’s own rules, it must complete the review of all applications within 30 days, or within 10 days of receiving any final information. But official figures show that the average weight increased from 31 days in June 2022 to 92 days in April
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for signing all studies that require participants to receive medications. These include testing new drugs and vaccines for the UK’s biggest killers, such as dementia, cancer and heart disease
Studies affected include those carried out by the NHS, universities and pharmaceutical giants, some of which are backed by millions in funding.
Researchers have warned that the delays are causing patients to wait longer for potentially life-saving treatments.
MHRA bosses blamed delays on a lack of staff and a spike in demand.
It has already received an additional £10 million from the government, partly to tackle the problem. The money, confirmed in March, was allocated to make UK-developed medical products available more quickly.
Critics say the backlog hurts Britain’s ambitions to become a science superpower.
The MHRA regulates clinical trials conducted in the UK, which are at the heart of the development of new therapies. For example, it had to approve the covid jab and drug trials, which were at the heart of the UK’s pandemic response.
As part of a series of strict controls, it ensures that all studies meet safety and ethical standards.
Under the MHRA’s own rules, it must complete the review of applications within 30 days of their submission, or within 10 days of drug companies answering any final questions about their project.
But official figures show that the average weight has increased from 31 days in June 2022 to 92 days in April.
MHRA chiefs hope the backlog will be cleared by September, but have warned the industry to expect delays until then.
Trials add around £2 billion to the UK economy each year and give patients early access to cutting-edge treatments. It also sees pharmaceutical giants hand over millions to the NHS to help with its research, which could otherwise be funded by taxpayers.
Professor Pamela Kearns, Director of the Cancer Research UK Clinical Trials Unit at the University of Birmingham, is conducting 100 trials at 347 sites in 21 countries, in collaboration with the UK government, charities and pharmaceutical companies.
She told MailOnline that these studies, including childhood cancer studies, are vital to “translating advanced science and research into improved patient care.”
But delays in approving clinical trials have ‘unfortunately been a major problem for us in an area where time is of the essence,’ added Professor Kearns.
Dr. Jennifer Harris, director of research policy at ABPI, told MailOnline that the delays mean 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 Britons taking part in industry-funded studies has fallen by 44 per cent since 2017, from 50,000 to 28,000 a year, she noted.
“Together, these challenges, alongside wider NHS capacity problems, are preventing patients from accessing cutting-edge treatments through research,” she said.
Dr. Harris added: ‘We know the government is aware of these challenges, evidenced by the £10 million award to the MHRA to bring new medicines and technologies to UK patients more quickly in the latest budget.
The MHRA is responsible for signing off on all studies where participants receive drugs. The graph shows the number of applications it received per month (blue) and how many it approved (red)
‘We hope to see further proposals soon to address the wider challenges facing clinical trials in the UK, following a number of independent government reviews.
“Getting clinical trials back on track in the UK is a vital piece of the puzzle if the UK is to realize the UK Prime Minister’s vision of a life sciences superpower.”
An MHRA spokesperson said: ‘We are aware that industry and researchers are facing longer time frames in their clinical trial applications.
“Many factors, including increased demand for our services, are leading to these longer timelines.
“To address this, we are taking a number of steps, including committing more resources to the areas that are in 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 give priority to applications where there is a risk to the patient or public health.
“We are confident that the actions we have taken will reduce the complexity of getting studies approved and ongoing and, most importantly, ensure that innovative treatments become available more quickly to the people who need them.”
It comes after a major review published last week looked at how to improve the environment for conducting clinical trials in the UK.
Former Health Secretary Lord James O’Shaughnessy, who was commissioned by the government, said complaints about the under-resourced MHRA were among the most common, with the delays posing a “significant barrier to more court cases being staged in the UK’.
A global pharmaceutical giant warned it would have to delay recruitment 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 prioritizes approvals.
Lord O’Shaughnessy said this gives researchers less confidence in starting trials in the UK.
Among his recommendations is that the MHRA set up a rapid task force to deal with delays and that the government allocate more money to it.