Innovative UK research project to study the value medicines bring to patients in the real world

Issued: Salford and London UK

Unique collaboration to ensure medicines under development meet patient and healthcare system needs

A new way to study the value medicines bring to patients and healthcare providers has launched in the north west of England.  The innovative ‘real-world’ research project will study the safety and effectiveness of a GlaxoSmithKline (GSK) late-stage investigational respiratory medicine alongside currently available treatments, as thousands of patients manage their chronic obstructive pulmonary disease (COPD) and asthma day to day.

Evidence generated from the study will complement GSK’s robust clinical trial programme assessing the medicine’s safety, efficacy and quality.

The Salford Lung Study is a unique collaboration between GSK, North West e-Health (NWeH), The University of Manchester, Salford Royal NHS Foundation Trust, NHS Salford, local GPs and local community pharmacists. Around 4,000 patients with COPD and 5,000 patients with asthma from Salford, Greater Manchester, will be enrolled in the year-long study, with around half receiving GSK’s investigational medicine and the other half receiving their existing therapies. 

It is the first time a large, prospective, ‘real-world’ study has been performed on a pre-licence medicine, across a large population within one geographical setting.  GSK’s multi-million pound investment in the research programme reflects the company’s commitment to invest in the UK and to ensure its medicines meet patient and healthcare system needs. What researchers learn from the study is intended to enable healthcare decision makers to more fully assess the medicine’s potential value at an earlier stage.

Medicines of value for patients & healthcare systems

Traditionally the safety and efficacy of investigational medicines (i.e. medicines that are not yet licensed) are demonstrated through randomised clinical trials. While critical to establish the safety and efficacy of a medicine, these studies tend to be highly controlled and enrol a more highly selected patient population than would be expected to be prescribed the medicine once it is available to patients. There is an increasing need for pharmaceutical companies to provide health technology assessment agencies and other healthcare decision makers with additional information on the health outcomes delivered by a medicine in the real world to establish the potential benefits and true value of a medicine. The Salford Lung Study aims to provide such information.

Realising the potential of electronic data

Electronic data from within the NHS provide a significant opportunity for health research and the potential to significantly improve medicines development and the understanding of how medicines are used by patients. The Salford Lung Study represents a unique collaboration between the pharmaceutical industry, academia, medical informatics and healthcare providers. It will utilise Salford’s e-Health records infrastructure – a clinical information system providing a single, integrated electronic patient record across both primary and secondary care. The Linked database system was created utilising the real-time, integrated data collected from a variety of sources including Salford’s e-Health records. It will ensure patients are closely monitored over the course of the study, but with minimal intrusion into their everyday lives.  This removes the need for the enforced interventions and controls required in traditional clinical trials which are not always representative of typical clinical practice.

Professor Ashley Woodcock, Professor of Respiratory Medicine at the University Hospital of South Manchester (UHSM), Head of the School of Translational Medicine at The University of Manchester, & Salford Lung Study Primary Investigator, said: “Traditional randomised controlled clinical trials conducted to register new medicines confirm their efficacy and safety in highly controlled settings and in a specially selected patient population. This is valuable information; however the data do not typically demonstrate how medicines perform in a normal clinical setting. This can make it difficult for decision makers to determine their possible value and this may subsequently restrict patient access. The Salford Lung Study aims to address this by collecting data in a more ‘real world’ setting, enabling us to better evaluate the potential impact on the healthcare system.”

Eddie Gray, President of GSK Pharmaceuticals Europe said: “GSK has over 40 years’ experience in respiratory medicine development and the Salford Lung Study reflects our commitment to develop innovative medicines of real value that will benefit patients and healthcare systems. The Salford Lung Study is an excellent example of collaboration between industry, academia and the NHS and we’re delighted to be working with the Salford healthcare community on this project. Our investment in this study reflects our commitment to the UK as a key life sciences research base.”

David Dalton, Chair of NWeH and Chief Executive of Salford Royal NHS Foundation Trust, said: “We are delighted that Salford has been chosen as the site for this ground-breaking new study. Salford is at the forefront of developing the most advanced and flexible information and analytical systems in the field of healthcare. Salford Royal and its colleagues in primary care have spent a decade developing integrated solutions for healthcare delivery which provide massive benefits to patients. It is the combination of our pioneering approach to integrated care and our integrated information systems which has made this study possible. I genuinely believe that through this collaboration with GSK and future studies, Salford can develop its potential to be a national centre for the improvement of population health.”

Professor Martin Gibson, Associate Director of Industry for the National Institute for Health Research (NIHR) Comprehensive Research Network (CRN) said:  "This is a major advance in the way we do clinical trials.  A successful result will be globally relevant to industry, health services and the general population because this is all about real world outcomes relevant to real people. The NIHR Networks are delighted to be supporting this important and ground-breaking study."

GSK and study partners discussed the Salford Lung Study with the MHRA and NICE via their joint scientific advice procedure and the study is subject to the usual regulatory and ethical requirements for traditional clinical trials.

The medicine being studied is an investigational once-daily inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA) combination treatment. The study will measure a number of endpoints including patient symptoms over time and any exacerbations that occur (worsening of symptoms); contact with health professionals for respiratory or other reasons and whether other medications to control symptoms are required. COPD patient recruitment is expected to begin in March 2012. The asthma programme is expected to follow in May 2012.

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Notes to editors:

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

North West e-Health (NWeH) - is a not for profit organisation and was established in 2008 by Salford Royal NHS Foundation Trust, NHS Salford and The University of Manchester. North West e-Health produces tools to transform health record data into better-informed care for patients and communities; and better-prepared environments for healthcare innovation. Its e-Lab technology enables healthcare organisations to assemble data, analytical methods and expertise quickly - providing business intelligence & reporting, clinical calculations, public health intelligence and research tools. The e-Lab protects the privacy of patients while providing auditable, low-cost, high-quality, reproducible analyses - building local capacity for making sense of local healthcare. www.nweh.org.uk/

Ken Cunningham, Chief Executive, NWeH said: “We’re delighted to be playing an integral role within this ground-breaking study. Our role is to develop and manage the e-Health technology that is key to providing rapid access to health data that can support clinical treatment decisions and patient management. The expertise and experience gained through this work will have long-term benefits for patients in Salford through more accurate and timely information about population health and healthcare.”

The Clinical Research Network - is part of the National Institute for Health Research. We provide researchers with the practical support they need to make clinical studies happen in the NHS, so that more research takes place across England, and more patients can take part.  www.crncc.nihr.ac.uk/ 

NHS Salford - funds healthcare services like GPs, dentists and operations for more than 230,000 people in Salford. Members of the public can stay in touch with NHS Salford by following www.twitter.com/nhssalford, searching for NHS Salford on www.facebook.com/ or visiting our website www.salford.nhs.uk/

Salford Royal NHS Foundation Trust – is an integrated provider of hospital, community and primary care services, including the University Teaching Hospital. The Trust has a turnover of £410m, employs 6,000 staff and provides local services to the City of Salford and specialist services to Greater Manchester and beyond. The Trust also offers specialist care to people from all over the UK who need expert help with brain, neuroscience, kidney, bone, intestine or skin conditions.  www.srft.nhs.uk/

The University of Manchester - a member of the Russell Group, is one of the largest and most popular universities in the UK. It has 22 academic schools and hundreds of specialist research groups undertaking pioneering multi-disciplinary teaching and research of worldwide significance. According to the results of the 2008 Research Assessment Exercise, The University of Manchester is now one of the country’s major research institutions, rated third in the UK in terms of ‘research power’. The University had an annual income of £788 million in 2009/10.

University Hospital of South Manchester NHS Foundation Trust (UHSM) - UHSM is a major acute teaching hospital trust providing services for adults and children at Wythenshawe Hospital and Withington Community Hospital. It is recognised as a centre of clinical excellence, demonstrated by mortality rates, which are the lowest in the region and among the lowest in the UK. It provides district general hospital services and specialist tertiary services to the local community.  Fields of specialist expertise include cardiology and cardiothoracic surgery, heart and lung transplantation, respiratory conditions, burns and plastics, cancer and breast care services. UHSM is also recognised as Britain's Greenest Hospital for its low carbon outputs.

Apollo Medical Systems - is the leading supplier of Primary Care data extracts to the NHS and Private Sector in the UK. Apollo is working with NWeH to extract key data from GP practices in order to assist the study. Apollo is proud to be selected as a partner in this impressive programme, efficiently providing timely accurate data without disruption to the busy participating surgeries.