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The New NIHR Clinical Research Landscape. NIHR Office for Clinical Research Infrastructure (NOCRI) Ravi Chana, Business Development Manager. Summary. INNOVATION PATHWAY – DECISION POINT. NIHR INFRASTRUCTURE TO SUPPORT RESEARCH. MODELS FOR EFFECTIVE PARTNERSHIP.

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The New NIHR Clinical Research Landscape


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    1. The New NIHR Clinical Research Landscape NIHR Office for Clinical Research Infrastructure (NOCRI) Ravi Chana, Business Development Manager

    2. Summary INNOVATION PATHWAY – DECISION POINT NIHR INFRASTRUCTURE TO SUPPORT RESEARCH MODELS FOR EFFECTIVE PARTNERSHIP NOCRI – SUPPORTING COLLABORATION

    3. INNOVATION PATHWAY

    4. The Decision Point Early-phase clinical research Late-phase clinical research Learn (early ‘go / no go’) Confirm (fail rarely) Delivery to time, budget and quality Shorter timelines

    5. What can the UK offer to industry? National Institute for Health Research (NIHR) World leading science World class facilities NHS patients

    6. NIHR INFRASTRUCTURE TO SUPPORT RESEARCH

    7. The NIHR Health Research System Faculty Associates Investigators &Senior Investigators Trainees Universities NHS Trusts Infrastructure Research Patients&Public Research Projects & Programmes Clinical Research Networks Research Schools Clinical Research Facilities, Centres & Units Research InformationSystems Research GovernanceSystems Systems

    8. NIHR Research Infrastructure Infrastructure Clinical Research Networks “…the support and facilities the NHS needs for first class research…” Clinical Research Facilities, Centres & Units

    9. NIHR Infrastructure Overview Invention Evaluation Adoption Early-phase clinical research Late-phase clinical research NIHR Biomedical Research Centres (BRCs) NIHR Biomedical Research Units (BRUs) NIHR Clinical Research Facilities (CRFs) Experimental Cancer Medicine Centres (ECMCs) NIHR Healthcare Technology Cooperatives (HTCs) NIHR Diagnostic Evidence Cooperatives (DECs) NIHR Clinical Research Network (CRN) NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) > £0.5 billion annual investment in relevant infrastructure to support clinical research at all points in the development pipeline

    10. Biomedical Research Centres (BRCs) £800million Government investment to support NIHR Centres and Units - the largest ever commitment to early stage health research Newcastle upon Tyne Cambridge Imperial Oxford University College Marsden* Great Ormond St* Maudsley* Moorfields* Southampton Guy’s and St Thomas’

    11. Biomedical Research Units (BRUs) Newcastle upon Tyne - Dementia Leeds – Musculoskeletal Manchester – Musculoskeletal Nottingham – Hearing Gastrointestinal Liverpool – Gastrointestinal Leicester – Cardiovascular Respiratory Nutrition, Diet, Lifestyle Birmingham – Gastrointestinal Cambridge – Dementia Oxford – Musculoskeletal University College – Dementia Bristol – Cardiovascular Nutrition, Diet, Lifestyle Imperial – Cardiovascular Respiratory Maudsley – Dementia Barts & London – Cardiovascular Southampton – Respiratory

    12. MODELS FOR EFFECTIVE PARTNERSHIP

    13. NIHR Translational Research Partnerships (TRPs) Pre-clinical research Early-phase clinical research Late-phase clinical research Point of intervention Pre-Clinical Models Biomarkers Patient stratification PoC Patient Tissues Phase 1 PoM Selected University and NHS Partners NIHR Biomedical Research Centres & Units Clinical Research Facilities NIHR Clinical Research Networks Translational Research Partnerships NOCRI

    14. NIHR Translational Research Partnerships (TRPs) • Translational Research Partnerships offer an internationally unique approach to support open innovation and collaboration with the life sciences industries. • Collectively they bring together formidable expertise and capabilities: • Recognised experience in current exploratory development protocols, expertise in pathophysiology and disease mechanisms, expertise in modelling; • Enabling technologies and infrastructure, including imaging, biobanks, accredited laboratory facilities; • Cohorts of well-characterised patients available for clinical development studies. • The Partnerships are supported by streamlined and efficient business processes, using standard contracts and unified operating procedures.

    15. Belfast Nottingham • Leicester Birmingham Oxford Imperial Southampton Operational Management Operational Advantages of the TRPs NIHR TRPs are delivering a number of distinct advantages to industry in early phase collaborative research. Newcastle Speed Quality Manchester 36 NHS Trusts and University partners Single Point of contact for industry Cambridge University College London Barts & London Kings College NOCRI

    16. TRPs & TRCs • Translational Research Partnerships (TRPs) • Inflammatory Respiratory Disease TRP • Joint & Related Inflammatory Disease TRP • Translational Research Collaborations (TRCs) • Dementia TRC • Rare Diseases TRC

    17. Healthcare Technology Co-operatives (HTCs) • Aims of the NIHR HTCs: • NHS “pull” for development of new medical devices, healthcare technologies and technology-dependent interventions; • Clinical areas and/or themes of high morbidity; • Work collaboratively with patients and patients groups, charities, industry and academics. • NIHR HTCs play a key role in: • Integration of clinical and patient need into definition of technology and product concepts; • Develop, test and improve product concepts leading to clinical evaluation and demonstration of care pathway benefits; • Reach across primary and secondary care and care services, professional bodies and national networks of clinical champions.

    18. Healthcare Technology Co-operatives (HTCs) Leeds Teaching Hospitals NHS Trust Colorectal therapies. Nottinghamshire Healthcare NHS Trust, Institute of Mental Health Mental health and neurodevelopmental disorders. Bradford Teaching Hospitals NHS Foundation Trust Wound prevention and treatment. Cambridge University Hospitals NHS Foundation Trust Brain injury. Sheffield Teaching Hospitals NHS Foundation Trust Devices for dignity. Barts Health NHS Trust Chronic gastrointestinal (GI) disease. University Hospitals of Birmingham NHS Foundation Trust Trauma management. Guy’s and St Thomas’ NHS Foundation Trust Cardiovascular disease.

    19. Diagnostics Evidence Co-operatives (DECs) • Aims • Catalyst for generation of high-quality evidence of clinical validity, clinical utility, cost effectiveness and care pathway benefits of commercially-supplied IVDs that is sought by a range of users, for example: • NHS clinicians and commissioners; • Accredited providers of NHS pathology services; • Companies involved in CE marking and marketing of IVDs; • NICE Diagnostic Assessment Programme. • Enable collaboration between clinicians and other healthcare professionals, patients and the IVD industry, staff of at least one accredited provider of NHS pathology services, NHS commissioners, academic researchers including health economists, and patient groups. • Create new, world-class methodologies for IVD assessment, where required.

    20. Diagnostics Evidence Co-operatives (DECs) Leeds Teaching Hospitals NHS Trust Liver diseases, Musculoskeletal diseases, Renal diseases. Newcastle upon Tyne NHS Foundation Trust Cancer, Cardiovascular disease and stroke, Genetics, Infection, Liver disease, Musculoskeletal disease, Respiratory, Transplantation. Oxford Health NHS Foundation Trust Primary care IVDs: Horizon scanning and rapid reviews to identify new and emerging IVDs, Identifying unmet needs for IVDs, Integrating primary care with laboratory services, Patient, carer and clinician factors in implementing IVDs, improving evidence for primary care IVDs. Imperial College Healthcare NHS Trust Cancer, Cardiovascular diseases, Gut health, Infectious diseases, Metabolic medicine, Primary Care, Respiratory diseases.

    21. Collaborations for Leadership in Applied Health Research and Care (CLARHCs) • Aims of the CLARHCs: • Develop innovative model for conducting applied health research and translating research findings into improved outcomes for patients; • Create a distributed model for the conduct and application of applied health research linking researchers with practitioners across the health community covered by the Collaboration; • Create and embed approaches to research and its dissemination that are specifically designed to take account of the way that health care is increasingly delivered across sectors and across a wide geographical area; • Increase country’s capacity to conduct high quality applied health research focused on the needs of patients, and particularly research targeted at chronic disease and public health interventions; • Improve patient outcomes across the geographic area covered by the Collaboration.

    22. Collaborations for Leadership in Applied Health Research and Care (CLARHCs) NIHR CLARHC Yorkshire & Humber – Sheffield Teaching Hospitals NHS FT Healthy children & families, Public health & inequalities, Telehealth & care technologies, Older people, long term conditions, Mental health. NIHR CLARHC Greater Manchester – Salford Royal NHS FT Patient-centred care, Community services & primary care. NIHR CLARHC North West Coast – NHS Liverpool Clinical Commissioning Group Public health, Mental health, long term conditions, personalised healthcare. NIHR CLARHC East Midlands – Nottinghamshire Healthcare NHS T Chronic disease, Older people, Stroke, Mental health. NIHR CLARHC West Midlands – University Hospitals Birmingham NHS FT Maternity & child health, Youth mental health, Prevention & detection of illness, Chronic diseases. NIHR CLARHC East – Cambridgeshire & Peterborough NHS FT Dementia, frailty & end of life care, Enduring disabilities & disadvantage, Patient safety, Patient & public involvement. NIHR CLARHC Oxford - Oxford Health NHS FT Mental health & dementia, Health behaviours, Patient experience & patient reported outcomes, Chronic disease self-management. NIHR CLARHC North West London – Chelsea & Westminster Hospital NHS FT Breathlessness, Frailty, Mental health, Public health. NIHR CLARHC West - University Hospitals Bristol NHS FT Chronic diseases (e.g. Dementia, musculoskeletal, vision, kidney, pain, depression, Parkinson’s), Public health intervention. NIHR CLARHC North Thames – Bart’s Health NHS T Mental health, Child & adolescent health, long term conditions. NIHR CLARHC South West Peninsula – Royal Devon & Exeter NHS FT Mental health & dementia, Diagnostics & stratufied medicine, Healthy people, Healthy environments, patient-centred care. NIHR CLARHC South London – King’s College Hospitals NHS FT Alcohol, Diabetes, Infection, Palliative & end of life care, Psychosis public health, Stroke, Women’s health, Patient & public involvement. NIHR CLARHC Wessex – University Hospital Southampton NHS FT Respiratory health, Ageing & dementia, Public health & primary care, Chronic liver disease, long term conditions, organisational behaviour.

    23. NOCRI – SUPPORTING COLLABORATION

    24. What is collaboration? Contract Commercial Research Academic Research Industry Led Collaboration Academic Led Collaboration Industry Collaborative Research • Joint planning, study design, resourcing, ownership and control of data

    25. Supporting collaboration with UK research infrastructure and experts Clinical Research Facility Research Centre KOL Commercial Partner Early phase study KOL Clinical Research Facility KOL Research Centre NOCRI Research Centre Clinical Research Facility KOL KOL Clinical Research Facility Research Centre

    26. Scale of opportunity for industry NOCRI supports industry through: • sign-posting • introductions • establishing collaborations • managing relationships Access via a single point of entry to world class science in world leading institutions and patients across the NHS

    27. To work with the Partnerships or any of the NIHR infrastructure contact the team at: nocri@nihr.ac.uk www.nocri.nihr.ac.uk