Salford Lung Study results show COPD patients treated with Relvar® Ellipta® achieve superior reduction in exacerbations compared with ‘usual care’
Pioneering GSK study provides important new data on the effectiveness of Relvar Ellipta (FF/VI) when used in everyday clinical practice
The highly anticipated results from the Salford Lund Study were announced by GSK on 24th May 2016 (http://www.gsk.com/en-gb/media/press-releases/2016/salford-lung-study-results-show-copd-patients-treated-with-relvar-ellipta-achieve-superior-reduction-in-exacerbations-compared-with-usual-care/).
24th May 2016 – Salford, UK – Healthcare professionals from eight organisations across Greater Manchester have collaborated to deliver the initial results of the Salford Lung Study (SLS). The study involved over 2,800 consenting patients, supported by 80 GP practices and 130 pharmacies in Salford and the surrounding Greater Manchester area.
This ground-breaking study, sponsored by GSK, examined the safety and effectiveness of a new treatment for chronic obstructive pulmonary disease (COPD). This was delivered in partnership with CK Aspire, NorthWest EHealth (NWEH), The University of Manchester, Salford Royal NHS Foundation Trust, Salford CCG, University Hospital South Manchester, South Manchester CCG and NIHR Clinical Research Network: Greater Manchester.
It is the world’s first digitally enhanced Randomised Controlled Trial (RCT) to include a broad and inclusive population of patients in an everyday clinical practice setting, embracing a novel approach to clinical trial design. This provides researchers with a breadth of clinical data that demonstrates the healthcare interactions of the everyday lives of patients and the way they use their medicines.
Conventional RCTs are usually conducted following strict inclusion criteria, which often exclude those patients with other multiple conditions. SLS was designed to include those patients who would often be excluded from a traditional randomised trial, for example individuals also being treated for other chronic diseases. This inclusive approach is important because it is more realistic of everyday practice and is therefore representative of a much wider patient population. The data provided by SLS will complement the existing data provided by the conventional RCT.
CK Aspire were engaged to build a team that could rapidly recruit and engage the local community of doctors and patients to take part in the Salford Lung Study. This
provided the opportunity to bring a new type of research to the region and also build a team with a new skill set conducting research in an innovative and progressive manner.
This collaborative study was placed in Salford because of the existing infrastructure of integrated electronic health medical records. The study relied on bespoke software, developed by NWEH and securely hosted within the NHS network that integrated the electronic medical records of consenting patients across all of their everyday interactions with their GPs, pharmacists and hospitals. This linked database system allowed close monitoring of patients’ safety in near real-time, but with minimal intrusion into their everyday lives.
By collecting healthcare information both quickly and efficiently, in line with best practice guidelines for security of patient data, the system offers responsiveness to patient safety, high quality data and short timelines for studies.
This digitally enhanced RCT design is a new and innovative approach to clinical trials; it is anticipated that the study methodology and underpinning technology could be used in future studies, not just in Greater Manchester but worldwide.
Sir David Dalton, Salford Royal Foundation Trust, and Chief Executive, said: “Salford has a rich history of pioneering health care and is now building one of the most innovative environments in the UK for conducting patient-focused health research and translating it into patient benefit. We are delighted that this ground-breaking study has taken place in Salford as a result of our close collaboration with NorthWest EHealth, GSK and Salford CCG. Together we are at the forefront of the development of healthcare focused on the needs of patients by providing modern, innovative and cost-effective care, embracing technologies, and ensuring that patients have the opportunity to take part in research. The combination of our pioneering approach to integrated care and our integrated information systems have made this study possible.”
Professor Martin Gibson, NorthWest EHealth. Chief Executive, said:
“This is not about Big Data, this is about understanding the way patients interact with medications in their everyday lives. Our unique technology supports understanding of NHS data to bring the right drugs to market quicker, whilst providing timely and accurate information on safety and cost for payers and patients alike.”
About CK Aspire’s Contribution to the Salford Lung Study
- Community and Patient engagement
CK Aspire’s team of healthcare professionals have helped community engagement in the study, supporting primary care practices and recruiting patients from a broad and inclusive population. The research nurse team has built strong relationships with surgeries, trained many people in Good Clinical Practice, provided a safety monitoring team liaising with secondary care and helped bring research to patients in everyday clinical practice
- Consent patients efficiently
CK Aspire’s team of research nurses embedded in the community made it possible for a large number of patients to be contacted and enrolled into the study quickly and efficiently. The research nurse team have consented 2800 patients to the study whilst based in 80 practices in Salford and Greater Manchester. We are particularly proud of our domicillary team who provided home visits to increase access to real world research and improve recruitment.
Telephone: 01438 842967 or
About NorthWest EHealth
NWEH is a UK based Academic and NHS collaboration which specialises in leveraging existing Electronic Health Records (EHR) to develop medicines more quickly, with improved safety monitoring for the benefit of patients, pharmaceutical companies, and payers.
- NWEH has led delivery on all the validated IT and EHR data aspects of the Salford Lung Study (SLS) robust Randomised Clinical Trial (RCT).
- NWEH has demonstrated that it is able to help improve patient recruitment, reduce study costs, increase patient safety (through near real-time safety monitoring), and provide better clinical trial data that has greater breadth and depth (i.e. all Primary, Secondary and Pharmacy EHR Data for study subjects both during, and before, their time on the trial).
- The technologies that NWEH have developed for use of existing EHR for robust RCTs, combined with their secure management of data within the N3*, are proven, established and replicable not only in the UK but in other digitised health economies across the globe.
NorthWest EHealth (NWEH) is a not-for-profit organisation formed by a partnership between the University of Manchester, Salford Royal Foundation Trust and Salford Clinical Commissioning Group.
Telephone 0161 672 5630 or
Hannah Murphy, Notch Communications
+44 (0) 161 817 5008
About The University of Manchester
The University of Manchester, a member of the prestigious Russell Group, is the UK’s largest single-site university with 38,600 students. It has 20 academic schools and hundreds of specialist research groups undertaking pioneering, multi-disciplinary teaching and research of worldwide significance. The University is one of the country’s major research institutions, rated fifth in the UK in terms of ‘research power’ (REF 2014), and has had no fewer than 25 Nobel laureates either work or study there. The University had an annual income of just over £1 billion in 2014/15. Visit www.manchester.ac.uk for further information.
Cancer is one of The University of Manchester’s research beacons – examples of pioneering discoveries, interdisciplinary collaboration and cross-sector partnerships that are tackling some of the biggest questions facing the planet.
- University of Manchester Health Informatics researchers have worked with both the NHS in Salford and GSK to create an environment in which electronic health records could be used to extend clinical trials in near real-time.
- From early studies with GSK’s former Information Factory over ten years ago to the current Salford Lung Study, there has been a forward-looking informatics research and development partnership between the organisations.
Professor Buchan, Professor of Public Health Informatics at the University of Manchester, said “The Salford Lung Study broke the mould of clinical trials by harnessing an approach to healthcare data and computing that focuses on populations not hospitals or other organisations; it operates using NHS data to offer the trial resources to the right patients, at the right time in the right way”.
About Salford Royal NHS Foundation Trust
Salford Royal NHS Foundation Trust aims to be the safest organisation in the NHS through providing safe, clean and personal care to every patient, every time. We are an integrated provider of hospital, community and primary care services, including the University Teaching Trust. Our team of 7,000 staff provide local services to the City of Salford and specialist services to Greater Manchester and beyond.
We are an Outstanding Trust – the first Trust in the North of England to achieve the highest rating given by the Care Quality Commission.