Trials supported by electronic health records – a game-changer for study design and execution
Professor Martin Gibson will be revealing the secrets of the successful delivery of GlaxoSmithKline’s (GSK) real world Salford Lung Study at BioData World Congress 2016 on 26 October in Cambridge.
Widely recognised as the first study of its kind globally, the Salford Lung Study is a large, prospective, real-world trial conducted across a patient population within a single geographical setting. It demonstrates a major advance in the conduct of clinical trials.
The study is evaluating a new treatment for Chronic Obstructive Pulmonary Disease (COPD) and asthma patients in a way that combines the robust scientific methodology of a Randomised Controlled Trial (RCT) – the gold standard in clinical trials – with the benefits of observing ‘real patients’ in a ‘real-setting’.
GlaxoSmithKline announced publication of the positive results from this pioneering study published in the New England Journal of Medicine (NEJM) and presented at European Respiratory Society (ERS) International Congress in London on 4 September 2016.
Novel approach to capturing patient data
A real novelty of this study, which reported initial headline results in May 2016, 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.
A further contributing factor was support provided by the National Institute for Health Research (NIHR) Clinical Research Network. The Network team based in and around Manchester supported the research team to engage 77 GP sites in Salford to deliver the study. Pharmacy also plays a key role in this ground-breaking research project. 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 took part.
Dr Sue Collier, GSK’s Head of Medical Operations for the Salford Lung Study, 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.”
A short animation describing the NIHR Clinical Research Network’s Study Support Service can be viewed here:
Find out more
Amid increasing demand for ‘real world’ methodology and data the successful delivery of the Salford Lung Study has sparked interest across the commercial world. Having supported the delivery of the study Professor Martin Gibson explains the learning from the project and explores potential for integration with additional data sources.
Professor Gibson will be speaking at 4pm on day one of the conference following the afternoon speed networking session. The NIHR Clinical Research Network team will be available to meet with delegates throughout the conference at stand 3 in the exhibition hall.
Martin Gibson is Clinical Director to Business Development & Marketing, NIHR Clinical Research Network, Chief Executive Officer of NorthWest EHealth, Director of the NIHR Clinical Research Network for Greater Manchester and Research and Informatics Director for the Greater Manchester Academic Health Science Network. He is a consultant physician specialising in diabetes and lipid disorders at Salford Royal NHS Foundation Trust where he was formerly R&D Director of both the acute and primary care Trusts. Martin is an active clinical trialist and has had a long-term interest in the use of electronic clinical data systems to improve healthcare and facilitate research.