The UK health service’s data-led approach to trials has helped to save millions of lives from COVID-19 worldwide — here’s how the NHS is setting an exciting new blueprint for all clinical trials.
In spring 2020, the severity of COVID-19 became clear. The NHS needed to find an effective treatment for a dangerous, contagious virus.
At the start of this pandemic, however — the scale of which the world has not seen in a hundred years — there was no clear view of how to tackle this virus. Medical researchers imagined it might take years to develop a vaccine, so alternative treatments needed to be developed and tested quickly to save as many lives as possible. It was time to start trialling medicines.
But there was a problem: traditional clinical trial methods are, for the most part, laborious and costly affairs.
For example, two trials of PCSK9 inhibitors, which lower cholesterol and reduce the chances of heart attacks, took 12 years to develop, at a cost of more than $1bn each. Trials that would take this long simply were not an option.
Mine of information
The NHS needed 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 holds, as well as new data flowing from COVID-19 patients. We made use of the NHS’s existing infrastructure and expertise in the UK’s universities.
At NHS Digital, as the data custodian for the health and care system, we already held a wide range of coded and analysable data that we could make available to researchers, scientists and public health officials for the benefit of health and care.
In March 2020, we had no way of making that data readily available for clinical trials but, as luck would have it, some important work was already under way. At the end of 2019, before the pandemic took hold, NHS Digital and its partners IBM, Microsoft and the University of Oxford’s Big Data Institute had been awarded funding to develop NHS DigiTrials: the Health Data Research (HDR UK) Hub for Clinical Trials.
Since then, NHS DigiTrials has been 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. NHS DigiTrials will support clinical trials at key points where patient data can make a real difference — to support feasibility and planning, recruitment of the right cohort and tracking what happens to participants’ health over time.
This approach could revolutionise the clinical trial sector. It will widen the opportunities for patients to take part in clinical trials; reduce the cost and complexity of developing new treatments; minimise those lost to follow-up; and even reduce the cost of medicines for the NHS.
For patients and clinicians, importantly, this approach will improve the effectiveness and safety of new treatments, and make them available more quickly.
Having a global impact
NHS DigiTrials came into its own when the pandemic hit. 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 delivered fast.
A weekly data extract from NHS Digital’s Secondary Uses Service, as well as other data sets including COVID-19 test data, is being used to help assess the effectiveness of several potential treatments for the virus.
The platform model adopted by RECOVERY allows multiple interventions to be tested at the same time, 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 are able to 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.
Data provided through NHS DigiTrials to the RECOVERY trial led to the steroid dexamethasone being found to help patients with severe COVID-19 — findings suggested the risk of death of patients on ventilators was cut by a third, while the patients on oxygen had their risk of death cut by a fifth. Dexamethasone has reportedly saved around one million lives around the world, and 22,000 lives in the UK, from COVID-19 since this breakthrough result was announced on 16 June 2020.
These phenomenal results show just how valuable NHS DigiTrials is, and on a global scale.
Raed mora at: https://pharmaceutical-journal.com/article/opinion/nhs-digitrials-how-the-search-for-covid-19-treatments-is-revolutionising-clinical-trials
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