The Salford Lung Study uses a new approach to clinical trials, monitoring patients in real-time to find out what happens when a new treatment for Chronic Obstructive Pulmonary Disease (COPD) is used in the ‘real world’. By linking together electronic healthcare records from a number of sources across the NHS, it was possible to track over 2,800 patients over a 12 month period to assess the effectiveness of the treatment in an everyday setting, rather than in a more artificial, clinical trial environment.

Why was this work needed?

In the UK, Chronic Obstructive Pulmonary Disease (COPD) is estimated to affect around 1.2 million people, so improving the available treatments is an important target in healthcare. Traditionally, clinical trials of new treatments have strict rules that exclude a large number of patients, for example patients with other multiple conditions such as diabetes or heart disease are often excluded from taking part. The Salford Lung Study (SLS) was designed to include those patients who would often be excluded from a traditional clinical trial. This inclusive approach is important because it is more realistic of everyday practice and is therefore representative of a much wider patient population. The SLS is pioneering a new way of conducting clinical trials that could give doctors and researchers a better idea of what happens when a new medicine is used in the ‘real world’.

What happened?

The Salford Lung Study looked at the safety and effectiveness of a new treatment for COPD. This collaborative study was placed in Salford because of the existing infrastructure of integrated electronic healthcare records. The study relied on the Linked Database System (LDS) developed by NorthWest EHealth (NWEH) and securely hosted within the NHS network, which linked together the data of consenting patients across all of their everyday interactions with their GPs, pharmacists and hospitals. This allowed the researchers to get a much more accurate sense of the impact of the treatment, for more typical people with COPD, than they would have had through the traditional clinical trial environment.

What were the benefits?

By collecting healthcare information both quickly and efficiently, in line with best practice guidelines for security of patient data, the NWEH system offers responsiveness to patient safety, high quality data and shorter timelines for studies. The initial results from this trial have shown that patients significantly benefit from the new treatment under investigation compared to current treatments used in everyday practice.

This study has also demonstrated the potential for running trials in a new way and so could have implications far beyond COPD.

What type of data was involved?

Patients were monitored through electronic healthcare records, which included interactions with GPs, hospitals and community pharmacies. National datasets were also included to ensure data was captured for patients visiting hospitals outside the Manchester area and to make sure the study team were alerted if a patient on the study changed their address.

All patients who participated in the SLS gave their consent to have their data extracted and linked together from a number of different healthcare locations.

Who funded and collaborated on this work?

The study was sponsored by GSK and delivered in partnership with NorthWest EHealth (NWEH), The University of Manchester, Salford Royal NHS Foundation Trust, CK Aspire, Salford CCG, University Hospital of South Manchester, South Manchester CCG and NIHR Clinical Research Network: Greater Manchester.

Where can I go for more information?

The Salford Lung Study comprises two studies; the COPD study with 2,800 patients that reported its first results in May 2016 and the Asthma study with over 4,000 patients that is due to report its findings sometime during summer 2017.

Pioneering Salford Lung Study achieves world first