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 is about 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 also reveals a potentially revolutionary shift in the way clinical trials are conducted in the UK.
A new service called NHS DigiTrials – jointly created by NHS Digital, the University of Oxford’s Big Data Institute, IBM and Microsoft – is at the heart of the story.
Ayten Basoglu, who works in the contact centre, and Karl Wallendszus, a data scientist, are just two of a dedicated RECOVERY trial team.
At NHS Digital, as 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.
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.
The RECOVERY trial is signposted at Addenbrooke's Hospital, Cambridge. Photo credit: Cambridge University Hospitals.
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.
Heather Pinches, Head of Clinical Trials Service at NHS Digital (pictured above) 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.”