An 'everyday' world first in clinical trials
Steam power drove the industrial revolution. Ford’s modern assembly line revolutionised manufacturing. And smartphones are reinventing the way we communicate. Now the way we design and carry out clinical trials is being turned on its head by the advent of the Salford Lung Study (SLS) - a revolutionary randomised controlled clinical trial that has been carried out in everyday clinical practice and could significantly increase our understanding about the medicines doctors prescribe.
SLS has been designed to explore how effective a treatment for chronic obstructive pulmonary disease (COPD) and asthma is, when it is used in everyday clinical practice.
Traditionally the effectiveness and safety of a medicine would be tested through double-blind randomised controlled trials. These typically take place in a highly controlled setting, with very few unplanned changes to treatment once the trial starts. The patients that take part in these trials are a specifically defined group that have to meet strict criteria to enter the trial. For example, patients who have a number of different illnesses would be excluded. The result is that the trials don’t always represent the patients that are prescribed these treatments.
Salford Lung Study has turned that on its head, helping us to understand the real value of medicines when they are used by patients who are going about their normally daily lives. SLS involves a broad and inclusive group of patients, and was designed to keep the patient experience as ‘normal’ as possible. Patients are seen by their own doctor or practice nurse, and pick up their prescription from their usual pharmacy.
I first found out about the Salford Lung Study when I went for a Lung Function Test and the nurse asked me if I would be interested in it. I told her that I would be interested in anything that’s going to move research forward.
The study has been made possible due to Salford’s electronic health medical records (EHR) system, which links patient records across GP surgeries and hospitals. GSK worked with the city’s pharmacies to also link them to the system, allowing comprehensive monitoring of patients in the study with minimal intrusion into their everyday lives.
The EHR system has created a unique medical infrastructure. The system was enhanced to capture health resource utilisation and outcome data. A platform was also developed to monitor patients, providing near-real time safety monitoring and reporting. This enhancement was built by NorthWest EHealth, a not for profit organisation formed by a partnership between The University of Manchester, Salford Royal Foundation Trust and Salford Clinical Commissioning Group. The EHR was a key reason for locating SLS in Salford.
A further unique collaboration that GSK has formed in designing the Salford Lung Study is with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) from whom we sought advice when designing the study.
The study has involved collaboration with thousands of patients, healthcare professionals and academics in the city of Salford, UK, providing an opportunity for many healthcare professionals to be involved in clinical research for the first time. More than 3000 people were trained as part of the study team, leaving a legacy for Salford as a unique research city, while creating data that can be generalised to patients world-wide.
What we’ve done is establish a new way of doing clinical trials which produces evidence that’s really valuable for patients, because it’s more relevant to them, and to healthcare professionals. Doctors will be able to say to people with COPD that this medicine has been studied in patients like you
The first results from SLS will relate to the effectiveness of medicines for chronic obstructive pulmonary disease. COPD is an umbrella term to describe conditions that limit airflow to the lungs including both chronic bronchitis and emphysema, and it often coexists with other chronic diseases. Globally, 329 million people are living with symptoms and risks associated with COPD.
We have already gained so many valuable insights in establishing the study and creating a research city in Salford that allows us to better evaluate COPD patients’ real-life treatment experience. We look forward to the results of the study which will provide data relevant to healthcare providers and patients around the world.