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NHS DigiTrials: Already saving lives

A new approach to supporting clinical trials helped researchers develop some of the most vital COVID-19 treatments - and is making it easier to quickly and safely test new medicines. 

A packet of dexamethasone tablets

The steroid dexamethasone may have saved more than a million lives since 16 June 2020.

The story behind the discovery of this breakthrough treatment for severe COVID-19 reveals the extraordinary expertise and dedication of a group of medical researchers trying to get a grip on a virus that was ravaging the world – but it also offers a glimpse of a potentially revolutionary shift in the way clinical trials are conducted in the UK.

Results needed quickly

In Spring 2020, medical research teams across the world had a problem. COVID-19 was infecting hundreds of thousands of people a week – and killing tens of thousands – but the traditional approach to developing treatments and vaccines would take years, not months to provide weapons to fight it.

For example, two clinical trials of PCSK9 inhibitors, which lower cholesterol and reduce the chances of heart attacks cost more than 1 billion each. On average, it takes 12 years to develop a new medicine.

Researchers needed to see results fast and at scale. The best way to do this was to tap into the existing wealth of data that the health service already held, as well as new data flowing from COVID-19 patients.

At NHS Digital, the data custodian for the health and care system in England, we hold a wide range of coded and analysable data that we can make available to researchers, scientists and public health officials for the benefit of health and care.

The RECOVERY trial is signposted at Addenbrooke's Hospital, Cambridge

The RECOVERY trial is signposted at Addenbrooke's Hospital, Cambridge. Photo credit: Cambridge University Hospitals.

At the end of 2019, NHS Digital and our partners IBM, Microsoft and the University of Oxford’s Big Data Institute were awarded funding to develop NHS DigiTrials, the Health Data Research Hub for Clinical Trials.

It is developing a range of data services designed to meet the needs of clinical trialists, using the wealth of routinely collected data held by NHS Digital. It supports clinical trials at key points where patient data can make a real difference – supporting feasibility and trial planning and tracking what happens to participants' health over time.

This approach has the potential to deliver a range of benefits: widening the opportunities for patients to take part in clinical trials and allowing research teams to follow up those individuals whose contact details have changed (for example, due to moving house). We can still follow their health outcomes unless they have moved out of England.

This all reduces the cost and complexity of developing new treatments and so cuts the cost of medicines and enables more promising treatments to be taken through trials.

For patients and clinicians, it also has the added benefit of improving the effectiveness and safety of new treatments as well as making them available more quickly.

NHS DigiTrials in the pandemic

What had been desirable improvement in 2019 was critical in the face of COVID-19. 

When our consortium partner, the University of Oxford, launched the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial to test potential treatments for patients hospitalised with COVID-19, we were able to respond quickly and to demonstrate that our approach could add value to a large-scale clinical trial.

Dr Marion Mafham

Dr Marion Mafham is the Data Linkage Team Leader for the RECOVERY trial, which tapped into data held by NHS Digital to test potential treatments for patients hospitalised with COVID-19.

A weekly data extract from NHS Digital’s Secondary Uses Service (SUS+), as well as other datasets including COVID-19 test data, is being used to help assess the effectiveness of a number of potential treatments for the virus.

The platform model adopted by RECOVERY allows multiple interventions to be tested within the same trial infrastructure, speeding up the trial’s ability to find effective and safe treatments.

By providing access to routinely collected data shared centrally by NHS DigiTrials, we can minimise the burden of collecting data from already pressed frontline NHS staff and provide data on trial participants from hospitals across England from a single source.

NHS DigiTrials data has also allowed researchers to link the trial cohorts to their medical history to enable a wider range of relevant medical information (for example, from their GP records) to be used. This has supported robust analyses about those most at risk from COVID-19 and assessment of whether treatments worked as effectively for different types of patients. All this has made the trial safer and more clinically effective.

World's largest clinical trial on COVID-19 treatments

Data provided through NHS DigiTrials to the RECOVERY trial led to the steroid dexamethasone being found to help patients with severe COVID-19. The findings showed that dexamethasone reduced deaths by one-third in patients on ventilators and by one-fifth in other patients receiving oxygen only.

Similarly, the RECOVERY trial demonstrated than an inflammatory treatment, tocilizumab, also reduces the risk of death when given to hospitalised patients with severe COVID-19.

The study of this intravenous drug, used to treat rheumatoid arthritis, was added to the trial in April 2020 and then stopped in January 2021 when it was decided enough patients had been enrolled to establish whether or not the drug had a meaningful benefit. The trial showed that for every 25 patients treated with tocilizumab, one additional life would be saved.

The results that we have seen in the RECOVERY trial have been phenomenal and have shown the value that NHS DigiTrials can have on the world’s largest clinical trial on COVID-19 treatments. 

As well as saving hundreds of thousands of lives through the identification of effective treatments for severe COVID-19 cases, RECOVERY also found that four other treatments that were being widely used globally provided no benefit for patients hospitalised with COVID-19, enabling clinicians and researchers to focus on other approaches.

Ayten Basoglu, who works in the RECOVERY trial's contact centre

Ayten Basoglu, who works in the RECOVERY trial's contact centre

Building on success

More recently, we have been working to support recruitment into another clinical trial - the Platform Randomised trial of Interventions against COVID-19 In older people (PRINCIPLE) Trial. This aims to find COVID-19 treatments that can be taken at home, to aid recovery and avoid the need for hospitalisation.

The study, which HDR UK played an important role in convening discussions for, initially looked at usual care at home to recover from coronavirus, against three separate drugs: azithromycin, doxycycline and inhaled budesonide.  Since then, a number of other treatments have been added and PRINCIPLE has reported its first results with inhaled budesonide, a common and inexpensive corticosteroid found to shorten recovery times in COVID-19 patients aged over 50 who are treated at home and in other community settings.

Although the study had been running since April, the participant numbers over the first 6 months remained low as it was hard to find and engage with patients in the community, especially when they were feeling unwell. They also have a very short timeframe of 7 to 10 days to recruit relevant participants following a positive COVID-19 test and start them on one of the treatments. 

By providing the PRINCIPLE trial team with a daily flow of COVID-19 test data, we allowed them to identify suitable trial participants who had tested positive for the virus and invited them to take part. The number of participants recruited to the trial doubled to 200 per week, although vaccine roll out and falling case numbers are now having an impact on recruitment.

By calling and explaining the trial over the phone to people at an early stage of their illness, researchers have been able to open up the opportunity to a wider range of potential trial participants.

Karl Wallendszus on an escalatorKarl Wallendszus, a data scientist on the project

The future of NHS DigiTrials

Platform trials like this have great potential beyond the pandemic.  There is a lot of interest in how this approach can make it faster and more efficient to find safe and effective treatments for widespread and common illnesses like cardiovascular disease.

They open up the opportunity for groups of researchers to collaborate on the same trial at the same time.  This structure also allows trials of different treatments to run simultaneously, all within a common trial framework and really lends itself to using routinely collected NHS data.

Heather Pinches, Head of Clinical Trials Service at NHS Digital says: “Through the NHS DigiTrials programme, we can reduce the cost of bringing new drugs to market and collaborate with clinical trialists to solve some of their challenges like finding and recruiting participants.”

It is not just about better use of NHS data, it is about changing NHS Digital’s approach to working with researchers. NHS Digital is working to streamline processes, improve support for users, and improve services with the needs of trials in mind.

“We are working closely with our Co-Development panel of patients and public, whose advice and feedback is influencing the way in which our services are developed and how we communicate about them,” Pinches said.

“We want to ensure that the public understand that their healthcare data is vital to improving health and care across the country and encourage more people to sign up for trials.

“We want to encourage more people from diverse backgrounds and age ranges to sign up to clinical trials like this, not just during the pandemic but as a permanent improvement. It will give us a better understanding how different demographics respond to treatments and improve health equality for all.”

Last edited: 15 March 2022 2:28 pm