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NHS DigiTrials enables improved treatments to transform lives
NHS DigiTrials was established in October 2019 to make it easier for researchers to establish and run clinical trials and for patients to participate in them. As the pandemic hit, the team quickly refocused efforts on supporting COVID-19 research, including providing data to help researchers at the University of Oxford to identify effective treatments for people in hospital with suspected or confirmed COVID-19.
Normally, a large clinical trial would take many months to set up, but the Randomised Evaluation of COVID-19 Therapy (RECOVERY) Trial was launched in just nine days and recruited over 10,000 patients across the UK within two months. The trial is taking place at 177 NHS hospital sites across the UK and is open to all patients hospitalised with COVID-19, regardless of age, gender, ethnicity, or geographical location. It has now recruited over 38,000 participants in the UK.
Researchers use patient data to assess whether treatments have an impact on the overall number of patients who survive COVID-19, besides other outcomes such as the length of hospital stay. Key breakthroughs of the trial so far are the discovery that the steroid dexamethasone reduces death in patients with severe COVID, and that an anti-inflammatory treatment, tocilizumab, further reduces the risk of death in such patients.
The trial has also found that other treatments that were thought to benefit COVID-19 patients, such as hydroxychloroquine and convalescent plasma, do not benefit those who are seriously ill. Such results have changed NHS and international medical practice, saved resources, and protected patients from the potential harms of ineffective treatments. In a rolling programme, the RECOVERY trial is still investigating a variety of other treatments.
Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford and joint leader of the UK-based RECOVERY trial said:
“By providing centrally collected and curated data on a weekly basis to track progress and outcomes of participants, NHS DigiTrials made the scale and speed of the RECOVERY trial possible. Within 100 days, the trial identified the world’s first coronavirus treatment proven to save lives – dexamethasone. The results were announced on 16 June 2020, adopted into UK practice later the same day, and included in new US guidelines within two weeks.
“Data-enabled trials like this have the potential to be used more widely outside of the pandemic. Using routinely collected NHS data and embedding research within clinical care makes it easier for patients and clinicians to participate in research.
“This approach could make it faster and more efficient to find safe and effective treatments for common illnesses like cardiovascular disease and cancer which place a huge burden on patients, their families, and the NHS. It also opens up the opportunity for trials of different treatments to run simultaneously, all within a common trial framework and using routinely collected NHS data.
“Through the NHS DigiTrials programme we can reduce the cost of bringing new drugs to the NHS, broaden participation in these trials, and deliver results that improve the care of patients with diverse backgrounds and needs.”
Wendy Coleman, (62) a staff member at the Chatsworth estate in Derbyshire said:
“I was hospitalised with COVID-19 in April and treated at Chesterfield Royal Hospital, where I was invited to take part in the RECOVERY trial. Through the trial, I was given two intravenous doses of tocilizumab. I am definitely glad that the NHS can offer patients the opportunity to take part in clinical trials such as the RECOVERY trial. I would encourage anyone who is offered the chance to take part in a clinical trial for COVID-19 research to participate. COVID-19 is the big unknown we are facing, whereas the risks from the drug treatments are minimal, so you really don’t have anything to lose.”