Thousands of clinical trials to find drugs for cancer and heart disease have stopped due to Covid-19

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Thousands of clinical trials to discover treatment for diseases, including cancer and heart disease, have been halted in the wake of the Covid-19 pandemic.

Seven in ten NHS research projects have been affected by the Covid-19 pandemic, analysis by Southampton University found.

One in ten – 1,500 – have been stopped entirely, which includes clinical trials for new medicines as well as laboratory research. 

Dr Michael Head, a senior member of the research team, said all areas of health had been impacted while research for Covid-19 steams ahead.  

Charities for major diseases, such as cancer and heart disease, are likely to have been hard-hit by a fall in funding for research.

But Dr Head warned the smaller charities fuelling research for rare diseases that have few treatments will find it hard to carry on.

It comes as a cancer charity today revealed that anxiety surrounding cancer has been ‘higher than ever’ because of Covid-19, with patients worrying about record-high waiting times and delayed trials. 

Thousands of clinical trials to discover treatment for diseases, including cancer and heart disease, have been halted in the wake of the Covid-19 pandemic (stock)

Thousands of clinical trials to discover treatment for diseases, including cancer and heart disease, have been halted in the wake of the Covid-19 pandemic (stock)

The figures shine a light on the catastrophic effect that Covid-19 has had on UK medical research.

It comes amid concerns about delays in care for other diseases, caused by coronavirus, which has led medics to warn survival rates will plummet. 

In March, the National Institute for Health Research (NIHR) said new clinical trials were to be suspended to prioritise Covid-19 studies, such as for treatment and vaccines.

Trials in the recruitment stage were also halted, with NHS trusts and health boards making decisions on a case by case basis.  

Hospital trusts had to consider if trial participants could be protected from Covid-19, because drugs can compromise the immune system, making it even more susceptible to the infection.   

WHAT TRIALS HAVE BEEN SUSPENDED?

1. A drug for motor neurone disease 

A Europe-wide survey to determine if the drug Tudca could halt the progression of motor neurone disease had to be suspended in March.

Patients in Italy, Germany, UK, France, Belgium, the Netherlands and Ireland were set to take part. 

Those given the drug during the 18-month study period would have been asked to visit the clinic every three months for routine checks of your symptoms – but this would have been risky during the Covid-19 crisis. 

Efforts are still being made to restart it at five British centres involved in the study.

2. A drug for stroke patients 

A study at Edinburgh University to determine if specific drugs could prevent stroke patients from going on to develop memory problems was paused in March.

R4VaD, funded by various charities, had recruited 1,271 patients at 53 sites by mid-March 2020 when the Sponsor suspended recruitment due to Covid-19.

Researchers obtained approval to continue recruiting during the Covid-19 pandemic and have since found stroke patients had been suffering high levels of anxiety due to lockdown. Therefore, Covid-19 may affect the long-term recovery of patients. 

3. A trial for surgery in elderly heart attack patients

Newcastle University were to find out if older, frailer patients could benefit from a procedure to restore blood supply to the heart muscle following a heart attack. 

Some 1,668 patients were to be recruited across the UK, and patients would be randomised to receive the invasive surgery 

The study, called the SENIOR-RITA trial, started in 2016 and was to last five to seven years. 

4. A trial of two tests to guide treatment for breast cancer

University College London Hospital NHS Foundation Trust halted the ROSCO breast cancer trial examining two tests to guide treatment for the disease. 

The trial, supported by Cancer Research UK, was looking at two tests called CEP17 and TOP2A to help doctors decide the best type of chemotherapy to give before surgery for invasive breast cancer.

The aims of the trial are to find out how well the tests work and more about quality of life. 

5. A trial for drugs to treat lung cancer  

The British Lung Foundation said in May it had had to pause a phase two clinical trial for new drugs to treat malignant pleural mesothelioma.

The condition, diagnosed 2,697 times every year, has no cure. Just five per cent of men and 10 per cent of women survive for more than five years.

Dr Samantha Walker, the director of research and innovation at Asthma UK and the British Lung Foundation, told The Telegraph: ‘This is not good news for a cancer where survival rates are dismal and there is no cure. 

6. A drug for Parkinson’s

In March, Geneva-based drug company Addex Therapeutics announced that it would delay the start of a clinical trial to treat involuntary movements in people with Parkinson’s disease.   

The trial, known as study 301, was of the compound dipraglurant to treat levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID). 

The company said the trial has ‘been postponed’ with no timelines in place for its restart because of the continued spread of Covid-19 in Europe. 

‘Sites are temporarily suspending on-site visits for monitors, vendors, and all other non-patient visitors and several sites have cancelled all non-essential patient visits,’ Dr Roger Mills, chief medical officer of Addex said.

The aim of pausing research also helped with the redeployment of clinical staff to frontline care to help treat the swathes of Covid-19 patients.

Clinical trials include caregivers and nurses who care for the patients involved, as well as the research scientists.

Laboratories have largely been requisitioned for mass coronavirus testing, and it’s not clear for how long they will be needed. 

Around 200 new trials are typically added to NIHR’s Clinical Research Network (CRN) portfolio each month – 2,400 a year. 

In 2018-19, the CRN supported over 6,100 studies and recruited over 870,000 participants.  

University of Southampton looked at the Edge database, which is used by NHS trusts to give information on research being conducted on NHS sites.

Early findings reveal that 70 per cent of research was impacted in some way as a result of Covid-19.

It includes clinical trials as well as epidemiology and laboratory studies, such as to look at risk factors for diseases. 

Some 60 per cent of projects – a total of 9,000 – were paused. They may have stopped recruiting patients because the risk of Covid-19 infection in hospitals was too high.

Some 10 per cent  – 1,500 – were shut down all together.

It is unclear currently the exact reasons why they stop, but could be because the research was time sensitive or there was not enough resources to wait, for example.  

Dr Head told MailOnline: ‘I guess looking back and reflecting, the numbers are not surprising. The pandemic has taken the world by surprise. 

‘We’ve shown globally and in the uk we are not prepared. And that will impact on research. 

‘Research is directed towards covid-19, which is necessary. But obviously that will impact on other areas of health. In terms of preparedness for the future, we need to make sure non-Covid types of research are in planning.’

The research is ongoing and so it is unclear exactly what areas have been impacted the most. This will become clearer over the next few months.

Dr Head said: ‘It might be that cancer research was not affected but stroke and mental health was. It won’t just be large diseases, but areas of health with few cases.

‘There will be research impacted that what will be rare or orphan diseases, where there isn’t much treatment available. 

‘Aspects of that might include motor neurone disease or haemophilia. If they are impacted it might hard for those charities to carry on.’

He added that it will be important to discover what knowledge would have been found had Covid-19 not halted medical research.

These ‘knowledge gaps’ will be important for moving forward in the treatment of patients, he said.

Dr Head told The Observer: ‘This pandemic has knocked everything off track. Research gives us the knowledge we need to tackle illnesses in new ways, and if that doesn’t happen all areas of health will suffer.’ 

A stark example of the harm caused to medical research by the pandemic is to cancer research, as large charities reveal the devastation in stark numbers.  

‘We had planned to spend £400m on research this year. That figure will have to be cut to £250m,’ Aoife Regan of Cancer Research UK told the Observer.

‘That is £150m of research on treatments with the potential to save or lengthen lives that will not now take place.’

If cuts continue to persist for four or five more years, it would mean hundreds of millions of pounds will be stripped from cancer research in the UK in coming years which will ‘send ripples beyond that’. 

The impact of Covid-19 on cancer patients has been at the forefront of discussions during the pandemic. 

Today, Dame Laura Lee, the CEO of cancer charity Maggie’s, said the past few months have been a difficult time for cancer patients.

Speaking on the BBC Radio 4 Today programme, she said: ‘It’s been hugely difficult. Cancer is not just a physical illness but it’s the psychological effects that has not just on the person but also the family.

‘With auto treatments and on many occasions treatment being ceased, people with cancer dying during this period, or finding that their disease has progressed, it’s been a heightened time of distress and anxiety.

‘Cancer always brings anxiety, a sense of aloneness, but during this Covid time, it’s been higher than ever. 

‘People are coming into our centres with that knowledge and information of what they’ve heard and worrying, ‘what does that mean for me?’

‘Our centre staff have never said they’ve ever dealt with such level of distress, feelings of anger, about the situation they find themselves in and actually, to a certain extent, feelings of abandonment with the NHS as well.’ 

Shannon Amoils, of the British Heart Foundation, said its research had ‘ground to a halt’ during the pandemic. 

A study at Edinburgh University was set to determine if specific drugs could prevent stroke patients from going on to develop vascular dementia. 

Another study at Newcastle University aimed to find out if non-invasive treatments could be used instead of surgical interventions for elderly men and women who had suffered heart attacks. 

Brian Dickie, of the Motor Neurone Disease Association, warned time was critical for the research of motor neuron diseases – which affect about 5,000 people in the UK.

He said: ‘Around 50 per cent of people with motor neurone disease will die within 18 months of their first diagnosis.’

Work to determine whether a drug called Tudca could stop the disease progressing is among the suspended trials.

Dr Dickie said: ‘These individuals are rapidly running out of time, so suspending projects like these is utterly heartbreaking.’    

The British Lung Foundation said in May it had had to pause a phase two clinical trial for new drugs to treat malignant pleural mesothelioma.

The condition has no cure and just five per cent of men and 10 per cent of women survive for more than five years.

Dr Samantha Walker, the director of research and innovation at Asthma UK and the British Lung Foundation, told The Telegraph: ‘This is not good news for a cancer where survival rates are dismal and there is no cure.

‘We completely 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, heartbreakingly, 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.’

Michael Lauer, deputy director for extramural research at the US National Institutes of Health, said the effect of Covid-19 on medical research goes beyond just trials.

In a article for The Lancet last week, he said: ‘There have also been tremendous disruptive effects on all biomedical research that is not directly related to Covid.

‘Laboratories are closed. Communications have been shut down, conferences have been cancelled, supply chains for equipment have been lost, resources have been lost. There have been widespread financial losses within academic medical centres that have had spillover effects on their research operations.’ 

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