Supporting efficient and effective clinical research in the UK

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1 Supporting efficient and effective clinical research in the UK National Institute for Health Research 10 years of delivering health and care research for the nation HRB CRCI Launch Dr Matthew Hallsworth Head of External Relations, NIHR Office for Clinical Research Infrastructure

2 Why is the UK Government committed to research in the National Health Service? Improve health outcomes through advances in research Improve quality of care by NHS participation in the research process Drive economic growth through investment by life science industries Strengthen international competitive position in science Increase Health and Wealth

3 Health Research Challenges, 2005 NHS R&D funding was allocated on a historical basis NHS Trust management was seen as the bureaucratic block to clinical research Universities NHS Patients Perception that NHS research funding was second class Perception that applied health research was second class Few effective incentives for research in the NHS Low applied evidence base Dramatic fall in numbers of clinical academics 40% of clinical academics funded by NHS Difficulty in developing sustainable capacity Problems with career paths for all professions in research

4 National Institute for Health Research Partnership Between Government, Charity and Industry Between NHS and University Between research leaders and research facilitators Between different health care professions Between different research disciplines Between researchers and patients A Health Research System

5 NIHR: A Health Research System Universities NHS Trusts Patients & Public

6 NIHR: A Health Research System Investigators & Senior Investigators Faculty Trainees Associates Infrastructure Clinical Research Facilities, Centres & Units Clinical Research Networks Universities NHS Trusts Patients & Public Research Research Projects & Programmes Research Schools Research Management Systems Systems Research Information Systems

7 The Innovation Pathway INVENTION EVALUATION ADOPTION DIFFUSION Creation new things new ideas new techniques new approaches Assessment new things new ideas new techniques new approaches Uptake new things new ideas new techniques new approaches Spread new things new ideas new techniques new approaches Basic Research Applied Research Commissioning Patient Care MRC & Charities NIHR NHS Commissioners Providers of NHS services Better Quality Better Value

8 Impact: NIHR CRASH-2 Intracranial bleeding study: the effect of tranexamic acid in traumatic brain injury Impact: British Armed Forces Txa now used in 75% of UK trauma patients NICE evidence summary: Unlicensed / off-label medicine: Death due to bleeding was reduced if tranexamic acid was administered up to 3 hours from injury Economic: Incremental cost of $64 international dollars ( 43) per life saved

9 NIHR: A Health Research System Investigators & Senior Investigators Faculty Trainees Associates Infrastructure Clinical Research Networks Clinical Research Facilities, Centres & Units Universities NHS Trusts Patients & Public Research Research Projects & Programmes Research Schools Research Management Systems Systems Research Information Systems

10 NIHR Clinical Research Infrastructure Invention Evaluation Adoption Biomedical Research Centres Biomedical Research Units Experimental Cancer Medicine Centres Clinical Research Facilities Translational Research Partnerships and Collaborations Patient Safety Translational Research Centres Healthcare Technology Co-operatives Diagnostic Evidence Co-operatives Clinical Research Network Colllaborations for Leadership in Applied Health Research and Care

11 NIHR-Supported Facilities NIHR Biomedical Research Units NIHR Health Protection Research Units NIHR Biomedical Research Centres NIHR Blood and Transplant Research Units NIHR Healthcare Technology Cooperatives NIHR Diagnostic Evidence Co-operatives NIHR-supported Clinical Research Facilities NIHR School for Public Health Research NIHR School for Primary Care Research NIHR/CR-UK Experimental Cancer Medicine Centres NIHR Surgical Reconstruction and Microbiology Research Centre NIHR Collaborations for Leadership in Applied Health Research and Care Peninsul a Newcastle Leeds Bradford Manchester Liverpool Birmingham Bristol Southampton Exeter Sheffield Nottingham Leicester Oxford London Brighton Cambridge

12 Expert translational research The NIHR has transformed the research landscape by investing biomedical research facilities and establishing collaborations that drive innovation in key areas

13 FOCUS ON: NIHR Biomedical Research Centres and Units

14 Millions Impact: Leveraged funding from the NIHR BRCs / BRUs ,041 1,200 1,000 NIHR Funding

15 NIHR Biomedical Research Centres onwards Announced in September 2016: New 816 million investment in health research MANCHESTER LEEDS SHEFFIELD NOTTINGHAM LEICESTER BIRMINGHAM BARTS BRISTOL

16 FOCUS ON: NIHR Translational Research Partnerships Bringing together expert centres across the UK to work collaboratively with life sciences industry on the early and exploratory development of new drugs and therapeutics Delivering cutting-edge translational research in Inflammatory Respiratory Disease and Joint and Related Inflammatory Diseases

17 FOCUS ON: NIHR Translational Research Collaborations Bringing together world-class researchers to respond to global health challenges working in partnership with industry and charities to carry out research to improved diagnosis, treatment and care Together these collaborations are addressing some of the greatest unmet needs in dementia and rare diseases

18 NIHR Rare Diseases Translational Research Collaboration (RD-TRC) Growing area of interest for industry: Patient need Model diseases for common diseases Challenge: poor assessment of natural progression of disease NIHR focus on developing deeply phenotyped patient cohorts 20M NIHR investment in Rare Diseases Translational Research Collaboration to Build capacity in rare disease research Establish deeply phenotyped patient cohorts, enabling better designed Phase 2 trials Establish a national database for rare diseases New collaboration opportunities with industry in rare diseases Successful NIHR open call for industry collaborative deep phenotyping studies 8 funded projects to date including A repurposing study of a marketed immuno-modulator in PAH Study cofunded by industry and NIHR - only possible through collaboration First potentially disease modifying treatment for PAH patients

19 NIHR Office for Clinical Research Infrastructure (NOCRI) NOCRI provide a single point of access to the NIHR s expert translational researchers and world-class research facilities nocri@nihr.ac.uk Timely access to high quality clinical infrastructure is a critical success factor for biotechnology companies. The contributions made by NIHR and the Institute of Cancer Research to Chroma s research highlight the significant benefits of tapping into the UK s clinical capabilities. Richard Bungay, Chief Executive Officer, Chroma Therapeutics

20 Delivering Clinical Trials in the NHS The NIHR provides the infrastructure that allows high-quality clinical research to take place in the NHS

21 FOCUS ON: NIHR Clinical Research Network 15 Local Clinical Research Networks (LCRNs) Research active clinicians across 30 therapy areas Detailed understanding of care pathways Flexible deployment of resources Links with rest of UK

22 FOCUS ON: NIHR Clinical Research Network FEASIBILITY Manage and deliver: Early Feedback Site Intelligence Site Identification COMMERCIAL COSTING TEMPLATES Support use Manage templates Trust, Primary Care & Device versions HRA APPROVALS SYSTEM FOR GAINING NHS PERMISSION Support use MODEL AGREEMENTS Support use STUDY MANAGEMENT Collect & collate data Performance manage study Feasibility Set-up Delivery

23 Impact: CRN recruitment

24 IMPACT: CRN RECRUITMENT At the end of 2014/15, the Network was recruiting to 862 commercial contract studies the highest number since records began in 2008/ Number of recruiting Commercial Studies supported by the NIHR CRN 2010/ / / / /15

25 Impact: Delivering studies in the NHS Proportion of eligible studies obtaining NHS permissions within 40 calendar days 100% % 80% 70% 77% 83% Number of Studies 60% 50% 40% 30% 24% 45% Percentage Obtaining Permission 20% 10% 0% 8% / / / / /

26 Impact: HRA timelines for ethics Prior to 2004: REC timelines were highly variable - some took more than a year From 2004: Single REC approval was introduced with a 60 day target to receive a final decision Now: 95% of applications to full REC receive final decision within 40 calendar days >90% of applications for proportionate REC reviews (low risk studies) receive a decision in 14 days

27 RAND Europe report published in May The NIHR is: Delivering benefits to patients Improving the health of the public nationally and internationally Making the nation s healthcare system more effective, cost-effective and safer Putting patients and the public at the heart of research Supporting a research infrastructure in the NHS

28 Impact: Money

29 Good luck on your journey ahead...

30 Thank you