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An introduction to the Salford Lung Study (SLS)

An introduction to the Salford Lung Study (SLS). Martin Gibson Director of GM CLRN. :. The need for real-world evidence. NICE clinical guideline 101:Chronic obstructive pulmonary disease. Treatment guidelines all based on double-blind, randomised controlled trials

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An introduction to the Salford Lung Study (SLS)

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  1. An introduction to the Salford Lung Study (SLS) Martin Gibson Director of GM CLRN Nov 13 UK/RESP/0151/13(1) :

  2. The need for real-world evidence NICE clinical guideline 101:Chronic obstructive pulmonary disease • Treatment guidelines all based on double-blind, randomised controlled trials • Nothing like real life - need to know what happens in the real world • SLS - will provide relevant and important information for clinicians, healthcare providers, payers and patients Nov 13 UK/RESP/0151/13(1)

  3. COPD 1.European Federation of Allergy and Airways Diseases Patients Associations (EFA). COPD. Available at: http://www.efanet.org/copd/index.html. Accessed on 15 February 2012. 2. British Lung Foundation. Invisible Lives report 2007. 3. ERS. European Lung White Book. 2003. Available at:http://dev.ersnet.org/uploads/Document/45/WEB_CHEMIN_1263_1168339451.pdf Around 210 million people worldwide currently have COPD1 Around 3.7 million people in the UK are thought to have COPD2 COPD kills around 30,000 people a year in the UK - more than breast, bowel or prostate cancer2 By the year 2020, it is predicted to become the third leading cause of death globally3 It is estimated that the direct cost of providing care in the NHS for people with COPD is almost £500 million a year2 Greater Manchester is ranked as one of the UK’s top ten COPD ‘hotspots’ (communities most at risk of future hospital admission with COPD) in the UK2 3 Nov 13 UK/RESP/0151/13(1)

  4. Asthma 1. World Heath Organization. Asthma Factsheet. Available at: http://www.who.int/mediacentre/factsheets/fs307/en/. Accessed on 14 February 2012. 2. Asthma UK. Key facts and statistics. Available at: http://www.asthma.org.uk/news_media/media_resources/for_journalists_key.html. Accessed on 14 Oct 13. 3. Asthma UK. The Asthma Divide - inequalities in asthma care for people with asthma in England. May 2007. Available at: http://www.asthma.org.uk/how_we_help/publishing_reports Accessed on 14 Oct 13.. Around 235 million people worldwide have asthma and it is the most common chronic disease amongst children1 In the UK, around 5.4 million people are currently receiving treatment for asthma ( 1.1 million children and 4.3 million adults)2 On average, three people per day die from asthma in the UK2 Asthma costs the NHS around £1 billion a year2 There were over 79,794 emergency hospital admissions for asthma in the UK in 2008-092 In the same year, up to 1.1 million working days were lost in the UK due to breathing or lung problems2 In north-west England, asthma-related hospital admissions are thought to be around 65% higher than in the east of England3 Nov 13 UK/RESP/0151/13(1)

  5. Efficacy to effectiveness Gold standard science to answer specific questions Evidence representing medicines in the real world Randomised Controlled Trials Double blind Double dummy Strict inclusion criteria Exclusions Adherence encouraged Frequent reviews Drugs provided Traditional Efficacy Endpoints Effectiveness Open label Broad population All comers Set in normal care No extra review Drugs prescribed and collected in usual way Health Outcome and Utilisation Endpoints i.e. Real life Nov 13 UK/RESP/0151/13(1)

  6. The opportunity for effectiveness research in Salford Salford is unique in the world in being able to deliver a large effectiveness study on a pre-license medicine The SLS is the first of its kind in the world Nov 13 UK/RESP/0151/13(1)

  7. Much more than just a database Nurse Team Academic Leaders Pharmacy One big paperless hospital Innovative GPs accepting integrated HC records Willingness and ‘can do’ GP Leaders Forward-thinking Trusts Nov 13 UK/RESP/0151/13(1)

  8. The Salford Lung Study partnership Salford Local Pharmaceutical Committee Salford Royal NHS Foundation Trust Nov 13 UK/RESP/0151/13(1)

  9. Data Flow for Linked Database System Pharmacies(prescriptions) Salford Royal NHS Foundation Trust Apollo (3rd party data transfer) GP Practices Salford Primary Care Trust Linked Database System NHS Information Centre (secondary user service (SUS)) PHT (questionnaire and IP) SIR eRT (spirometry and ECG supplier) Office for National Statistics (ONS) (deaths) SUS ONS Quest (central labs) Exeter (deaths and moves) Exeter GSK (anonymised information only) GSK (OCEANS data) Nov 13 UK/RESP/0151/13(1)

  10. How the data is gathered Nov 13 UK/RESP/0151/13(1)

  11. Geographical Extension • Challenge of recruiting sufficient study subjects in Salford area to ensure statistical viability of study • Where to find extra subjects? • Willing GP investigators? • Willing pharmacy partners? • Secondary Care Facilities able to provide robust safety monitoring? • Impact of workload for study staff and partners • Increasing complexity of project • Solution found by extending study to parts of Trafford and South Manchester • University Hospital South Manchester able to provide robust inpatient monitoring Nov 13 UK/RESP/0151/13(1)

  12. Due diligence prior to study • Retrospective study of COPD in Salford • How good is the data quality • How many people have asthma/COPD? • Can NWeH identify • Safety data required by MHRA • Event data • Health utilisation data? • Can NWeH make sense of the data • Perform analysis that GSK (NICE) require • What else could we do? Nov 13 UK/RESP/0151/13(1

  13. Some of ourachievements to date • 49 GP practices taking part • Over 1500 patients recruited • All 58 community pharmacies involved • All GP and pharmacy staff involved fully trained in Good Clinical Practice • Hospital safety team established • 50+ nurses in the community team • The sense of ‘can do’ and collaboration between partners Nov 13 UK/RESP/0151/13(1

  14. Salford Selected for lung disease treatment trial RESEARCH World first for GPs in Salford as 54 practices help examine benefits of COPD and asthma treatment Salford GPs pioneer first ‘real world' drug study GSK seeks real-world Relovair evidence with Salford Lung Study One of the first of these "real world" studies is the GSK Salford Lung Study. Taking place in addition to formal clinical trials, it is assessing a new inhaled therapy for asthma and chronic obstructive pulmonary disease. Liz Dawn on her battle with COPD “Drug company GlaxoSmithKline is working with the NHS to compare a new treatment with those already on the market” Nov 13 UK/RESP/0151/13(1)

  15. The SLS Patient Recruitment Websitehttp://www.salfordlungstudy.co.uk Nov 13 UK/RESP/0151/13(1

  16. Summary • The Salford Lung Study is a world-first “real-life” clinical effectiveness study • Maintains scientific rigour • randomised, • active control • robust primary endpoint • It has, and continues to be an enormous logistical effort • This will offer important information for clinicians, healthcare decision makers and most especially patients • The SLS will provide valuable information about how to conduct real-world effectiveness studies in future Nov 13 UK/RESP/0151/13(1)

  17. Salford Quays Nov 13 UK/RESP/0151/13(1)

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