Case study: Delivering real world research - The Salford Lung Study
The UK as a clinical trials destination: Delivering ground-breaking ‘real world’ research
GlaxoSmithKline’s (GSK) Salford Lung Study is considered the fi rst of its kind globally – a large, prospective, real-world trial conducted across a patient population within a single geographical setting. The study is evaluating a new treatment for Chronic Obstructive Pulmonary Disease (COPD) and asthma patients in a way that combines the robust scientifi c methodology of a Randomised Controlled Trial (RCT) - the gold standard in clinical trials - with the benefits of observing ‘real patients’ in a ‘real-setting’. It demonstrates a major advance in the way we do clinical trials.
Double blind RCTs have a robust methodology, involving specifi c patient populations, in a highly controlled setting. This approach helps to isolate the effects of the medicine or treatment. However, the RCT makes the setting artificial. As a result, it is diffi cult to tell if the medicine or treatment will work the same when used in the ‘real-world’ where other factors need to be considered such as: variations and errors in medicine administration; and interactions with medications for other conditions.
Historically, ‘real-world’ evidence has been acquired by conducting observational studies. However, when the randomised element is removed a study can have an inherent bias. For example, the new medicines may be reserved for the most ill patients. Consequently the results are not as reliable in scientific terms. The Salford Lung Study bridges this gap. It complements the traditional RCT by combining its scientifically robust methodology with the benefits of an observational study.
Most research asks ‘does this treatment work’? The Salford Lung Study asks ‘does this treatment work in the real world’? In addition, traditional RCTs tend to use eligibility inclusion and exclusion criteria which may mean that as few as 7% of patients are eligible to take part. In the Salford Lung Study there are few exclusions. As a result, the study participants are much more representative of the real COPD and asthma patient populations. Finally, the Salford Lung Study creates a natural setting for patients – it’s business-as-usual with their treatment. Throughout the study the patient continues to be looked after by their usual practice nurse or general practice doctor (GP) in a normal way. They even continue to visit their usual pharmacy to collect their medication.
The COPD arm of the Salford Lung Study published initial results in May 2016 on the GSK website (http://bit.ly/2e90of7). Recruitment for the asthma arm of the study is ongoing.
Collaboration is key
A real novelty of this study is the way that technology is used to capture patient data. North West e-Health in collaboration with Salford Royal NHS Foundation Trust, NHS England: Salford, and local general practices and pharmacies, have developed an Information Technology (IT) system which provides a single, integrated electronic patient record across both primary and secondary healthcare settings. Study participants give permission for their medical record to be visible over this system. This allows the research team to monitor the patient’s health and safety in ‘real time’ over the course of the study with minimal intrusion into their daily lives.
“The Network was crucial in developing relationships with the practices, getting them on board, explaining what’s involved, providing Good Clinical Practice Training, and advising on the delivery of the study in this ‘real world’ setting. Without the support of the Clinical Research Network at a local level this study would never have happened.”
Dr Sue Collier, GSK
The role of the NIHR Clinical Research Network
The Clinical Research Network team based in and around Manchester supported the research team to engage 77 GP sites in Salford to deliver the study. This is a large proportion of the total GPs in the area. When looking to involve so many practices within a small geography it was inevitable that many would not have been involved in delivering research previously. Dr Sue Collier works for life-sciences company GlaxoSmithKline (GSK) as Head of Medical Operations for the Salford Lung Study. She said:
“The Network was crucial in developing relationships with the practices, getting them on board, explaining what’s involved, providing Good Clinical Practice Training, and advising on the delivery of the study in this real-world setting. Without the support of the Clinical Research Network at a local level this study would never have happened.”
Pharmacy also plays a key role in this ground-breaking research project. One of the challenges was to galvanize the pharmacy community - to maintain the ‘real world’ approach every single pharmacy across Salford had to be actively dispensing the study medication when the study opened. More than 120 pharmacies are taking part and over 1700 pharmacy staff have been trained to deliver the study.
Keeping it real - the future
There is an increasing demand for ‘real world’ methodology and data and the successful delivery of the Salford Lung Study has sparked interest across the commercial world. Having supported the delivery of the study the Clinical Research Network in the UK now has a template. We understand the complexities and the diffi culties and have developed a model that we can apply even earlier in the development process for even better real-world studies.
Find out more Visit our website at: www.nihr.ac.uk/life-sciences-industry