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Delivery of clinical trials through managed networks

Delivery of clinical trials through managed networks. Jonathan Sheffield CEO, NIHR Clinical Research Network. What we’ll cover. The brief history of Research Networks in the UK The forces shaping studies and the priorities for Research Approaches to successful delivery for Research.

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Delivery of clinical trials through managed networks

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  1. Delivery of clinical trials through managed networks Jonathan Sheffield CEO, NIHR Clinical Research Network

  2. What we’ll cover • The brief history of Research Networks in the UK • The forces shaping studies and the priorities for Research • Approaches to successful delivery for Research

  3. 2006: policy watershed • National Institute for Health Research created to implement policy • Thriving research culture • Fairness of access to research across England • More patients and health professionals participating • Increased industry investment • NHS as an international leader • Healthcare professionals proud to work in a research-led, evidence-based NHS • Health and healthcare improved by research evidence

  4. Policy landscape has evolved

  5. National Institute for Health Research:integrated health-research system > £0.5 billion p.a. investment in relevant infrastructure to support clinical research at all points in development pipeline

  6. Network development • NIHR Clinical Research Network in place across all therapy areas: supports an infrastructure for research • Funding follows activity: opens up NHS to research • Primary Care and Comprehensive Research Networks created • Creation of Mental Health Research Network 2001 2003 2005 2006/7 2009 • NIHR Clinical Research Network in place • Stroke, DeNDRoN, Diabetes and Medicines for Children Research Networks established • Launch of National Cancer Research Network

  7. Research past… • Research mainly centred on acute teaching hospitals • Culyer funding • Equality of opportunity for patients to participate in clinical studies? • Research funders: lack of nationwide infrastructure to conduct research

  8. So what has changed? Supporting the life-sciences industry in UK clinical research delivery

  9. Network Infrastructure • People • Appropriate training • Flexibility • Expertise • Information • Infrastructure with reliable systems • Management • Metrics and Support

  10. One national network • Research active engaged clinicians across all 30 therapy areas • Detailed understanding of care pathways

  11. Study delivery and management:Managing performance with quality • A research-ready workforce • 10,000+ GCP-trained nurses embedded in the National Health Service to support investigators with patient identification, screening, clinical delivery • Proactive study management support • Study milestone schedule; monthly reviews of recruitment, RAG rating of studies to a site level • Trouble-shooting from the inside • Our strong relationships with clinicians and detailed knowledge of other potential sites gives you options if a study hits a recruitment problem

  12. Study set-up • CSP: system for gaining hospital permission • Do paperwork once only for multi-centre trials • Network staff in the National Health Service work on your behalf, using relationships to push study set-up through on the inside • Commercial costing templates • Transparent prices to assist planning • Speeds up cost negotiations • Model agreements • Standard contract accepted across the NHS • Eliminates the need for lengthy legal review

  13. Is it working? • Research is becoming more embedded • 99% of NHS Trusts now research-active • Progress with “hard-to-reach areas” Key:Red 0 to 50 studiesPurple 51 to 100 StudiesBlue 101 to 200 studiesYellow 201 to 250 studiesGreen 251 to 400 Studies NHS Trusts by number of studies recruiting patients in 2011/12 Sources: 2011/12 NIHR CRN annual report; Guardian Clinical Research Zone

  14. Research present… • Patient involvement in clinical studies has increased • 630,000 patients recruited into CRN Portfolio studies in 2012/13 Key:Yellow 0 to 500Blue 501 to 1,000Green 1001 to 5000Purple 5001 to 10,000Red more than 10,000 NHS Trusts by number of patients recruited to studies in 2012/13 Source: 2012/13 NIHR CRN annual report

  15. EU total clinical trials Data source: MHRA UK

  16. UK v the world • Patient enrolment per year, by country as a percentage of the Global Total. Data source: Anonymous CRO - there is no single source for patient recruitment data, however, this graph shows where one leading CRO is choosing to put their studies

  17. UK Today • Number of UK commercial trial applications received • Data source: Medicines and Healthcare products Regulatory Agency

  18. The evidence: study set-up • Trend: projected further 30% improvement in study set up times for 2013/14

  19. The evidence: time and target • Year on year improvement • % of studies delivered to 100% target within 100% time has more than doubled in two years (all therapy areas) • % even higher in some therapy areas Percentage of Network commercial studies recruiting to 100% target in 100% time Studies recruiting to 100% time & target Year * 63% of studies met 90% or more of their recruitment target

  20. Network has evolvedat local level during 2013/114 • 102 overlapping local networks will become 15, each covering research delivery across all therapy areas • Boundary alignment with AHSN areas • Will form strong working bonds with AHSNs • Increased efficiency within stable funding Note: map still in development and subject to change

  21. Geographical variations

  22. Current Challenges • Stratified medicines: • Intensive genotyping and phenotyping • Larger number of smaller studies: multi-centre and specialist in nature • Fewer patients required – but harder to find; use of technology for feasibility becomes key • Current “individual” investigator model may be unsustainable where only a few patients will be recruited at each centre.

  23. Cancer Research UK Strategy 2014 “Our ambition in cancer drug development is to redefine how cancer is treated and to accelerate the delivery of the next generation of medicines to patients who need them. Our understanding of the genetic aberrations underlying cancer development and how resistance to therapies develops, underpins the large number of molecules now in development. Academic research plays a critical role in this, with new models of interaction between academia and industry driving ever faster progress.” Dr Susan Galbraith AstraZeneca

  24. BIG data • Big Data – stitches data sources together: volume, velocity, variety • Clinical Practice Research Datalink: NIHR supported; will give the UK a unique selling point for researchers • Clinical Research Network: linking Portfolio with NHS datasets to assist study feasibility • CRN open data platform: dashboard tools to make our data more useful – available from summer

  25. “Big data’s potential in pharmaceutical R&D is enormous. Armed with vast amounts of biological data and the tools to process it – cutting-edge analytics, streaming massively parallel processing and domain-specific access and query technologies – the industry will be able to develop more effective personalized medicines. It will also be able to shift focus from reaction to prevention.” PwC: Pharma 2020 report

  26. “Real world” studies

  27. What future for theindividual investigator? • Increasing complexity of trials • Need for speed and delivery • Tracking patients • Clinical Research Networks provide a better option whether self or organizationally mediated

  28. Campaigning to support patient involvement The Network campaigns to raise the level of patient and public awareness about clinical research and the role it plays in developing better treatments, and encourage patients and clinicians to engage in clinical trials Recent campaigns include: • Mystery Shopper • OK to ask • Focus on…

  29. Patients want to engage • Association of Medical Research Charities consumer poll June 2011: 97% of the public believe that it’s important the NHS should support research into new treatments • NIHR Clinical Research Network consumer poll May 2012: 82% of people said it is important for the NHS to offer opportunities to take part in a clinical research study • National Cancer Patient Experience Survey: 95% of those who discussed research were glad to have been asked; 53% of those who did not discuss research said they would have like to have been asked

  30. Role of www in patient recruitment • Highly-sophisticated online patient recruitment, self-monitoring and support systems now in place • Role of social media in driving patients to study sites • UK Clinical Trials Gateway developing in that direction • Customer route to research may be different in the future: patients take initiative

  31. Conclusion • The NIHR funding and networks are to support research throughout the NHS • We work to support research delivery for all specialties • We are active in all NHS environments • Patients support and want to be involved in research • Further information on the networks please go to: • www.crn.nihr.ac.uk

  32. Final message: it’s about patients The new treatment has given me hope. If it is successful, it will be better than winning the lottery. Clinical trial patient

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