It has been revealed that life-saving research is on hold due to a three-month backlog in approving medical trials. Any study involving giving humans drugs must be signed off by the Medicines and Healthcare products Regulatory Agency (MHRA), including testing new medications and vaccines for diseases such as dementia, cancer and heart disease.
However, the watchdog’s approval process, which should take a maximum of 30 days, has tripled to three months since last summer, with some being delayed for six months. Researchers have warned the delays mean patients having to wait longer to receive any potentially life-saving treatments.
MHRA chiefs have blamed delays on a spike in demand and a lack of staff. The body has already received an extra £10 million from the Government, in part to deal with the problem, which was allocated to make medical products developed in the UK available more quickly.
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 said the studies, including childhood cancer trials, are crucial to “translate cutting edge science and research into improved patient care”, but added that delays getting clinical trials approved has “sadly been a major issue for us in a field where time is of the essence”.
A spokesperson from the MHRA, 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.”
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Posted by Karen Motley, Clinical Negligence Department, Chadwick Lawrence LLP, medical negligence lawyers and clinical negligence solicitors in Huddersfield, Leeds, Wakefield and Halifax, West Yorkshire.
