Scientists are warning that UK drug regulator delays mean a key trial seeking ways to treat the long-running Covid risks running out of money before it ends.
Researchers looking for treatments that could benefit the millions of patients with long Covid, who currently have no approved medicines, waited up to six months for the Medicines and Healthcare products Regulatory Agency to approve adaptations that they are required to decide on within 35 days.
The Stimulate-ICP study is inspired by the UK’s main recovery trial, which found drugs to use against acute Covid-19. It has enrolled just 900 of the 4,200 participants it intended to recruit, and its funding from the UK’s National Institute for Health and Care Research runs out in March.
But while the regulator moved quickly to allow testing during the pandemic, the Long Covid study was stuck in a backlog at the agency, which has seen significant staff cuts since Brexit.
Amitava Banerjee, a professor at University College London who is co-leading the study, said it was “really frustrating” because the study was funded but stopped because the MHRA did not have enough capacity to respond promptly to requests.
“We’re now in a situation where I’m struggling to see how we can get through this. And the worst case scenario is we have unfinished work,” he said.
“If we are unable to answer questions, that is tragic for the patients who don’t get answers and for the taxpayers who have had their money wasted.”
The UK government is promoting the NHS as the ideal place for clinical research. But the pharmaceutical industry has warned it is falling behind other countries because of regulatory delays and an overburdened healthcare system.
The Chancellor gave the MHRA a further £10 million in this year’s budget to help speed up the approval process for “cutting-edge treatments”.
The agency said it took “urgent action” over the summer and that most of the delayed applications for clinical trial approval had already been processed. He added that, from September 1st, all new and fully compliant applications will be evaluated within the legal deadlines.
Scientists are also concerned that after March the NIHR will no longer have money set aside to research long Covid. Daniel Altmann, professor of immunology at Imperial College London who is examining the biology of long Covid in a separate study, said it is “very strange” because medical research takes time and is rarely completed in just two years.
“Why on earth would you want to make the initial investment if you don’t follow through and deliver?” he asked.
The NIHR said it has invested more than £50 million in long Covid research projects and that project deadlines could be extended if researchers and funders agreed. It added that scientists could submit proposals for new research through regular funding routes.
Around 1.9 million people, around 2.9% of the UK population, are living with self-reported symptoms of long Covid, according to data released in March by the Office for National Statistics.
Emma Wall, an infectious disease consultant leading the Stimulate-ICP study with Professor Banerjee, warned that without robust research, many patients are turning to unproven and often expensive treatments.
“There’s a snake oil economy. People are making money off these desperate patients because there’s this vacuum of good research,” he said.