How non-Covid patients are paying the price for frantic vaccine search

The hunt for a vaccine or a virus treatment has seen thousands of clinical trials suspended, meaning patients will wait far longer for new therapies, figures show.

Just one quarter of the trials overseen by the National Institute for Health Research are progressing as usual, with a further 16 per cent forced to make changes. Nearly six in 10 have been stopped entirely.

A survey by the institute – to which 4,758 of 5,544 study groups responded – found that 2,817 trials have ground to a halt. If extrapolated to all the trials, it could mean as many as 3,409 have shut down since the epidemic started.

In March, the NIHR also suspended new applications for trials saying coronavirus must be given “the highest priority”, although that decision was reversed last Thursday and the institute said it would now be working towards unpausing ongoing research and setting up new trials. Yet with labs requisitioned for mass coronavirus testing, a lack of clinical supplies and research nurses drafted to help on the front line, the U-turn is unlikely to bring any immediate relief.

Many patients have been unable to leave lockdown to attend trials, and studies have experienced such damaging interruptions that they will need to start again or have to be abandoned completely.

There are also fears that charities will no longer be able to afford to fund research, with many experiencing huge drops in donations since the crisis began.

The Association of Medical Research Charities believes there will be a £250million shortfall in available funds for trials and research in 2021 from its members.

More than 900 (70 per cent) of clinical studies funded by the AMRC, involving 148,000 patients, are currently stopped, paused or delayed.

Aisling Burnand, chief executive of the AMRC, said: “For many patients, the opportunity to take part in clinical research provides hope and losing this opportunity is devastating.

“Clinical research is vital to the development of new treatments and improved understanding of diseases, and for some it can be a crucial lifeline. Stopping trials can have a significant physical and emotional impact.”

Cancer Research UK funds around 200 trials involving 25,000 patients but said it had been forced to cut funding, pause research and stop recruiting for new trials.

The charity is expecting to see a 25 per cent decline in fundraising income this year because of the pandemic, which it says will directly impact its goal to see three in four people survive cancer by 2034.

Emlyn Samuel, Cancer Research UK’S head of policy, said: “Clinical trials have been severely disrupted during the pandemic, with the set-up of new trials paused and many existing trials not able to recruit new patients.

This is worrying for cancer patients with few other treatment options.

“Plans to get clinical trials back up and running when safe and able to do so are in place and we’ve heard that some cancer trials have already started recruiting patients again. But it’s important that more trials restart quickly to ensure cancer patients can access innovative treatments.”

The British Lung Foundation said it was forced to pause a phase 2 clinical trial for new drugs to treat malignant pleural mesothelioma, a condition for which there is currently no cure.

Dr Samantha Walker, director of research and innovation at Asthma UK and the British Lung Foundation, said: “This is not good news for a cancer where survival rates are dismal and there is no cure. We understand the need to focus on Covid-19 right now, but the impact will be colossal, with huge repercussions on the research community and patients, who don’t have time to spare. This will mean delays in the trial going ahead and any potential new treatments reaching those who need them.”

The British Heart Foundation was funding around 900 grants, involving more than 1,500 researchers.

Dr Sonya Babu-narayan, associate medical director at the BHF, said: “Unfortunately much of our research has been disrupted, with universities closing and clinical trials delayed due to the pandemic. We need to ensure that patients and the public can still reap the benefits of BHF research. Our priority is that the research we are funding is successfully completed, and our researchers are fully supported.”

Elsewhere, most major drugs companies have been forced to stop trials. In March, Addex said it would delay the start of a clinical trial to treat involuntary movements in people with Parkinson’s disease.

US pharmaceutical giant Eli Lilly announced that it would halt enrolment in 86 ongoing studies and delay the launch of new trials including 30 in final phases. GSK has also paused new trial recruitment while Roche said it had seen impacts on clinicaltrial continuity “in all the regions where we conduct clinical studies”.

Belgian drug maker Galapagos has paused enrolment into seven studies of filgotinib, a drug to treat diseases of the immune system.

Many life-changing drugs expected to come to the market this year are now likely to be delayed including the asthma medicine tezepelumab, fitusiran, a haemophilia therapy and ozanimod for multiple sclerosis. The Alzheimer’s Society called for financial support from the Government to help charities survive the lockdown and get trials back on track.

Fiona Carragher, director of research and influencing for the society, said: “While we had seen an acceleration in dementia research, the pandemic has put the entire world on pause, locking researchers out of the lab, halting clinical studies and deploying clinical staff back to the front line to support Covid-19 efforts.

“We need emergency support from the Government to continue funding life-saving research to improve the lives of people with dementia and provide hope for the future.”

Kate Shaw, CEO of Innovative Trials, which helps recruit patients, said three quarters of the trials it supports had been disrupted.

“Getting trials back up and running will need a lot of investment from pharmaceutical companies,” she said. “It will not be business as usual.”

This week, the NIHR set out a new framework to try and help some trials resume or get started. Dr William van’t Hoff, chief executive of the NIHR’S Clinical Research Network, said: “It’s right that we make sure research can be resumed as soon as NHS or care services are able to restart across the country.”

‘For many patients, clinical research provides hope and losing this opportunity is devastating’