The pharmaceutical industry has called on the government to develop a plan for the restarting of non-COVID-19 clinical studies that had been placed on hold with the outbreak of the pandemic.
According to BioWorld, while restrictions were lifted in May, only 45 per cent of the suspended trials had reopened to recruitment as of 9 September, no new trials are starting, and there is increasing concern surrounding progress.
There are remaining issues with patient recruitment, trial oversight, long waiting time for non-COVID referrals, and a lack of research staff.
Concerns are heightening as the second wave of coronavirus infections means that cases are rising again, which is threatening further disruption, according to the Association of the British Pharmaceutical Industry (ABPI), which has drawn attention to the issue as it publishes its second annual report on the state of clinical trials in the UK.
There is also the difficulty of the increase in other respiratory illness and infections during there winter months, and the uncertainties that remain on the terms on which the post-Brexit transition period will end when the UK leaves the bloc on 31 December this year.
“The U.K. performs well on the world stage in clinical trials, but COVID-19 is presenting us with many challenges,” said Richard Torbett, chief executive of ABPI. “It is crucial that the government has a plan for the safe and sustainable start of non-COVID trials.”
According to Aisling Burnand, CEO of the Association of Medical Research Charities (AMRC), which represents charities that collectively fund 17,000 scientists and invests over £1.2 billion per annum in research, the decision to suspend clinical trials has had a significant impact on participating patients and their families.
With COVID-19 affecting 126,000 patients, over half of AMRC members have had to delay clinical trials.
Burnand said AMRC has been working to get non-COVID studies restarted. “Some progress has been made, but it’s clear that a restart is very challenging,” she said.
Ironically, the UK’s response in starting and running COVID-19 clinical trials has been work leading, as the government developed a process for nationally prioritising, rapidly approving, and opening studies.
Of the most notable of those is the randomised Recovery trial, which has recruited 13,268 patients in 176 hospitals and demonstrated the HIV/AIDS combination therapy lopinavir-ritonavir and the antimalarial drug hydroxychloroquine are not effective, while the corticosteroid dexamethasone is.
The results from the Recovery trial have led to worldwide changes in clinical guidelines.
The ABPI has said the new ways of working inspired by the pandemic need to be embedded to ensure the changes enable future clinical trials to be conducted more efficiently in all disease areas, including COVID-19.
Cheng-Hock Toh, vice president of the Royal College of Physicians, said that the health crisis has led to long-overdue improvements in how quickly trials can be set up.
“But a key obstacle still holding back clinical research in the U.K. is clinicians not having the time to participate, despite their keenness to become more involved,” he said.
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