Take one city, 233,900 inhabitants, 3000 trained healthcare professionals and study facilitators and 235 million rows of data, and you have a ‘research ready city’. Salford, a metropolitan borough of Greater Manchester, recently became the first place in the world to host a real-world study of what was, at the time, a pre-licence medicine for lung disease, one of GSK’s inhaled COPD and asthma medicines . In the process, it has established itself as a unique place in the world where researchers can carry out clinical trials in a real world setting to complement existing randomised clinical trials which typically take place in very carefully controlled settings.
Healthcare decision makers have been asking for data which is more representative of real populations for some time. After all, drugs and therapies have to work in real-life settings, not just in idealised conditions where most people are excluded because they have other diseases or potentially confounding factors. For example, some research has suggested that just seven per cent of COPD patients would be considered eligible for a standard randomised clinical trial.
But the difficulty has always been how to actually achieve this while retaining scientific robustness. Salford was pinpointed by GSK investigators after a global search because it already had existing highly developed electronic shared record system for patients who used primary and secondary care in the area. Their Single Integrated Record system is one of the earliest in the UK and is now highly evolved with most people in the area ‘opting in’ to the project. It started as a way to monitor diabetic patients based at Salford Royal NHS Foundation Trust but was gradually expanded to cover many other areas of healthcare including respiratory medicine – the area which we wanted to explore. The system allows clinicians to share information and facilitates continuity of patient care, but it also provides an invaluable resource to researchers – something they understood very well from the outset.
The North-West e-health, an organisation formed by a partnership between The University of Manchester, Salford Royal Foundation Trust and Salford Clinical Commissioning Group, were able to build on the existing system to include pharmacies and extract data from the electronic records which can be used by researchers and academics. In the past, they have used this data to look at local epidemiology and health trends. The team from NWEH were keen to work with us to deliver this innovative study.
We also needed to have the buy in of the local community and healthcare workers who needed to drive the study. We worked with the local GPs (who were trained as part of the trial) who contacted their ownCOPD patients aged over 40 who had had an exacerbation of their symptoms within the previous three years, and obtained their informed consent to take part. We taught around 3000 healthcare professionals how to be study investigators, and how to input data correctly so it could be used. There was a huge amount of training involved for this one study, but the expertise is now in place for future studies to take place.
The key thing was that this was a ‘real world’ study so we wanted patients to carry on as usual. Although they were randomised as to whether they got their usual COPD medication or the study medicine, they and the doctors knew what they were taking. There was no one hovering to ensure that they took their medication exactly at the right time in the right way – we wanted them to behave like normal patients who often forget or may take their medicine at a different time of day. If a GP wanted to change the medication half way through the trial for clinical reasons, he or she could do that. The details of prescribing, GP visits and side effects were recorded electronically in real time.
The wealth of data that we now have will hopefully give us a better understanding of how people respond to the drug in real life situations, although admittedly it is taxing our statistical teams since it can be highly individualised. We are keen to know how the medicine works, but we are also collecting lots of health resource data, like hospital stays, amount of prescribing and how much this all costs to the healthcare system. This is useful information that is being shared with our partners to improve outcomes for patients and drive efficiency in the NHS.
The COPD Salford Lung Study results have just been published in the New England Journal of Medicine and were presented at the European Respiratory Congress.