Conducting data-driven clinical trials that are better, faster and more efficient than ever before, is one of Health Data Research UK’s national priorities. Electronic health records hold the key to enabling every individual across the UK to have access to the latest treatments and technologies through access to clinical trials. It used to be a great challenge and take a long time to find a sufficient number of the right patients to enrol into a trial and would rely on tapping into local networks that not all doctors/researchers have access to. These days a large portion of NHS records are electronic, so in theory we should be able to search the database for patients that could benefit from a particular trial and source participants from the whole population (not just one NHS Trust for example). These are just some of the challenges of conducting great clinical trials which data science can address.
This approach has been put to the test since the emergence of COVID-19. A national clinical trial, which aims to include all COVID-19 patients across the UK, has been set up in record time, to test three drugs against COVID-19. Such trials normally take months to set up, but this one has been set up in a matter of weeks, without cutting corners – purely as a result of all those involved expediting processes and working together.
Possible treatments for COVID-19
The three medicines being tested are normally used to treat other conditions, so they have already been cleared for safe use in people. There is reason to believe that they may also be effective against COVID-19. The treatments are Lopinavir-Ritonavir, Interferon β and low dose corticosteroids. The trial is looking at whether any of these treatments are effective in treating COVID-19 hospitalised patients. Currently there are no known treatments for COVID-19 so this is vital work.
Race against time
The data-driven approach to this study means that once set up and linked with routinely collected health records, minimum effort on the ground – beyond the usual course of care – is required to implement the trial. This is important to note, as burden of research on clinicians and nurses must be minimised at all costs. So it’s a race against time to get the trial sites set up. Already ethics approval has been obtained, and random selection of the first consenting patients across the four nations has commenced – patients who have tested positive for COVID-19 are beginning to be recruited into this trial from England, Wales, Scotland and Northern Ireland.
Approvals are being obtained to link other health-related datasets to: increase the number of trial participants, track outcomes for patients, and understand how pre-existing medication regimes may interact. Going forwards, the trial has been designed such that new treatments can be included and ineffective ones dropped as the trial progresses. With over 100 participating hospitals at a time of severe capacity issues, manual data collection is not feasible, so electronic health data streams would provide critical information efficiently. This will enable ongoing monitoring to enhance patient safety and trial progress, as well as inform the interpretation of the results.
The people involved
This study is being led by Health Data Research’s lead for the Clinical Trial national priority, Martin Landray (part of HDR UK Oxford).