National Industry Event 2014 Delivering life-sciences industry research Martin Gibson, Associate Director for Industry, NIHR Clinical Research Network Delivering research to make patients, and the NHS, better As a clinician • • • • • • Patient benefit (sometimes the only way to get the drug) Personal development (makes you better at the day job) Publications (a few) Prestige (often not much) Pecuniary interest (variable) Pump-priming (own portfolio) As an R&D Director • • • • • • Patient benefit (and safety) Professional development (of staff + motivation) Publications (can stack up in large organisations) Prestige (more important in some organisations) Pecuniary interest (can be significant) Pump-priming (increasingly the only source) As a CRN or national lead • • • • • • Patient benefit (at regional and national this can be large) Professional workforce (safety + virtuous circle) Publications (significant – nationally relevant) Prestige (significant – nationally competitive) Pecuniary interest (UK plc – inward investment/retention) Pump-priming (strategic localism) THE NIHR CLINICAL RESEARCH NETWORK Helping the NHS to do research national system ● local capability ● global delivery NIHR CRN: Greater Manchester • • • • • One of fifteen regional networks One of the smallest by population (2.9m) and geography A budget of ~£18.9m for 2014/15 Hosted by Central Manchester NHS Foundation Trust 12 provider Trusts, 3 mental health trusts, NW ambulance Trust and 14 CCGs Local Delivery • • • • Evidence based feasibility Specialty Lead Support Explore new opportunities New Investigator prospects • NHS • Life-sciences Industry • Coordinating Centre • Industry Operations Manager • Industry Facilitators • • • • • Business Focused Customer Service Training & Quality Single point of contact Escalation Greater Manchester site identification GM site intelligence Local performance management Greater Manchester: • Get it right from the start; SSV • Established relationships with research teams, R&D, support departments, CRA, Project Manager, escalation points • Local performance meetings with CRN Senior team every 2 weeks. • Information systems to support delivery with key triggers Industry Team Contact List Shared Mail box – [email protected] Bev Watson Industry Operations Manager Sarah Fallon Research Facilitator T: 0161 726 8005 M: 07557 804 526 [email protected] Julia Pugh Research Facilitator T: 0161 701 5605 M: 07557 804 528 [email protected] Paul Hedgeland Business Development Manager M: 07414 903 703 [email protected] Helen O’Brien Feasibility Officer/Research Nurse GM CLRN Mobile: 07584280559 [email protected] Hilary Prais Industry Team Support Mobile: 07827 887 953 Email: [email protected] Commercial 550 Academic 2692 MHRA CTA authorisations Phase 2/3/4 800 700 CTA numbers 600 500 400 300 200 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Year Innovation • • • • • • • • International competition Demand increasing New medicines more quickly Payers Faster delivery to time and target at reduced cost Targeted therapies New trial designs – real world, adaptive ‘Big Data’ FEASIBILITY RAPID RESULTS RECRUITMENT Real world trials using EHRs Salford Lung Study RF/FFT/0071/14 20 EFFICACY TO EFFECTIVENESS Gold standard science to answer specific questions Evidence representing medicines in the real world Randomised Controlled Trials Effectiveness Double blind Double dummy Strict inclusion criteria Exclusions Adherence encouraged Frequent reviews Drugs provided Traditional Efficacy Endpoints 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 21 PROTOCOL OUTLINE Primary endpoint: Moderate/severe exacerbation (defined by oral steroid (and/or antibiotic use) +/- hospitalisations ) Secondary endpoints: Serious Pneumonias, Healthcare utilisation, COPD Assessment Test (CAT) 2800 patients New Rx open label • Patients in primary care, aged 40+ • GP diagnosis of COPD • Taking ICS,LABA,LAMA alone or in combination • Exacerbation in last 3 years • Consented Visit 2 Randomised Routine respiratory review Device instruction CAT 12 months of normal care Visit 6 Routine respiratory review CAT Existing maintenance Rx, ICS, LABA,LAMA Constant real-time data collection of all HC interventions/safety monitoring RF/FFT/0071/14 22 DATAFLOW FOR LINKED DATABASE SYSTEM Apollo Participating GP Practices (3rd party data transfer) Participating Pharmacies (prescriptions) GraphNet (3rd party data transfer) NHS Information Centre (secondary user service (SUS)) Office for National Statistics (ONS) (deaths) Salford CCG SIR Linked Database System Participating Hospitals SUS ONS Exeter (deaths and moves) Exeter GSK (anonymised information only) GSK (OCEANS data) 23 SOME ACHIEVEMENTS TO DATE • Over 70 GP practices taking part – in Salford, Trafford and South Manchester. • Over 120 “high-street” pharmacies involved in Salford, Trafford and South Manchester. • Over 2000 GP and pharmacy staff involved fully trained in Good Clinical Practice. • Purpose designed eCRF and monitoring IT system built and operating for over 2 years • Hospital safety team established and working over 2 hospitals. • Over 100 nurses and facilitators in the community team • The sense of ‘can do’ and collaboration between partners RF/FFT/0071/14 24 Summary • • • The NIHR Clinical Research Network – A national system delivering local capability – Performance managed – Successful Innovation – Adaptive – Flexible – Cutting edge Cannot work in isolation – Collaborative – Customer focused