Highlighting local differences through real-world data

CKD is a long-term and progressive condition where the kidneys gradually lose function, sometimes leading to kidney failure. It is often associated with getting older but can affect anyone of any age.

The most common causes are diabetes, high blood pressure and glomerulonephritis (damage to the tiny filters inside your kidneys). While many people with CKD are able to live long lives with the condition, it is associated with low quality of life, an increased risk of heart failure and premature death. There is no cure for CKD but treatment, including lifestyle changes and medicines to control associated problems, can help to relieve the symptoms and slow its progression.

When setting up clinical trials for CKD treatment across the globe, pharmaceutical firm AstraZeneca approached Imperial College Health Partners (ICHP) to help test the feasibility of running a trial in the UK. The trial looked to include men over the age of 18 and women of non-childbearing age. However, on closer inspection, the trial’s global protocol was far more complex than this. It covered multiple inclusion and exclusion conditions, over and above sex and age, including blood pressure measurements, additional health conditions, and whether or not a patient had previously taken certain medications.

To accurately estimate the result of applying this protocol to CKD patients in the UK, ICHP turned to the real-world data contained within the Discover dataset. Led by ICHP, Discover-NOW is pioneering the use of real-world evidence (RWE) in health research and provides access to one of the largest depersonalised linked health datasets in Europe, covering a population of more than 2.3 million in North West London.

RWE research uses health data that has been collected through real-life activity, such as health appointments and from mobile devices. The multi-stage study on behalf of AstraZeneca, which took place over the course of a month, relied upon collaboration and insight from a wide network of healthcare professionals to ensure the data available was thoroughly interrogated and understood.

Working with an array of different experts and clinicians, the ICHP team were able to identify 12,163 patients with a CKD diagnosis, of more than one million people in the Discover dataset who met the age and sex criteria.

However, after applying all the different inclusion criteria to the data, the team were able to identify just 30 people who would have been eligible for the trial. Furthermore, after excluding anyone affected by renal or cardiac disease from this select group, they found that they were left with no patients at all.

While this may not have been the answer AstraZeneca were hoping for, it’s a resounding endorsement for the value of using deidentified electronic health records, like those available in Discover, to help prove or disprove the feasibility of a clinical trial.

Working with ICHP on this study before commencing work on a trial in the UK means AstraZeneca were able to avoid wasting valuable time and resources. But the work didn’t stop there. Using their in-depth understanding of the UK’s population and vast network of healthcare experts, ICHP were able to offer advice on how the trial’s global protocol could be altered for use in the UK. This included identifying and explaining local nuances and working with UK-based clinicians to look for different markers that could be applied.

As a result, ICHP and AstraZeneca have gone on to set up a new collaborative project looking at opportunities to redesign clinical pathways for CKD in the UK.