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
JPS to set context on DH NIHR infrastructure from bench to bedside supporting life sciences industry, whether CRO, pharma, med tech- small or large. The whole infrastructure is there to support the product lifecycle.

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
Launch of National Cancer Research Network
Stroke, DeNDRoN, Diabetes and Medicines for Children Research Networks established
NIHR Clinical Research Network in place

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
Needs to say that the CRN is the research delivery arm of the NHS. We partner with people to place their study in the UK with confidence. Expert in all therapeutic areas and work in a national to local/local to national model. Staff embedded at the NHS trusts to deliver studies.

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
Self explanatory- focus on performance management.
To focus on the RAG reports and active performance management of our studies.

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
Self explanatory- tools to drive down start up timelines (link to earlier performance slide of start up timelines/0

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

14. Patient involvement in clinical studies has increased
Research present…
Patient involvement in clinical studies has increased
630,000 patients recruited into CRN Portfolio studies in 2012/13
Key: Yellow 0 to 500 Blue 501 to 1,000 Green 1001 to 5000 Purple 5001 to 10,000 Red 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
Data source: Medicines and Healthcare products Regulatory Agency
Rest of Europe anonymised
UK was in decline – stabilised since the Network was established
Importantly, this data shows our position in relation to Germany – considered as the leaders in Europe
Relate to US - Global data that we have looked at from Biopharm Insight – suggests USA decline in % share of global trials from over 45% in 2005 to below 40% in 2011 (provided by NOCRI, opted not to include)

16. UK v the world
Patient enrolment per year, by country as a percentage of the Global Total.
IMPORTANT TO POINT OUT :
Data Source: Anonymous leading global CRO - there is no single source for patient recruitment data, so the data for that graph is from one CRO and gives an indication of where they are choosing to put their studies
“Data limitations: This graph is based on data from This is historical data which represents a time when the clinical research environment was not seen as conducive for commercial sponsors to conduct research in the UK. “
This slide shows that the UK has more than doubled its share of global patient recruitment over a 3 year period from
This is a trend that we have seen echoed in our own NIHR CRN patient recruitment figures since 2011 – further slide about recruitment follows
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
Data source: Medicines and Healthcare products Regulatory Agency
Slide is self explanatory – Trend: phase 2/3/4/ CTAs on increase
Note its CTAs only
Point out when the Clinical Research Network was established and began to make an impact

18. The evidence: study set-up
Trend: projected further 30% improvement in study set up times for 2013/14
These figures are for commercial contract research only
Interim results for this financial year (38 days for Q1 an 28 days for Q2) so far show that this positive trend is continuing and early predictions suggest we could be looking at as much as a further 30% improvement. JPS needs to highlight that this is the evidence for the myth that the UK is slow.
[we also need IM to amend this slide to show the figure, rather than 118]

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
This is evidence for reliability of UK performance. JPS needs to accept that performance was patchy in the UK but we have turned this around with this change and driving performance management culture locally at the site level. Needs to explain the 100% time and target being strict (100 patients in 6 month window, so 99 patients in 6 month window frame is a fail). (63% in Q1 and Q2 this year).
Trend: Further increase this year
63% for Qtr. 1 & 2
67% for Qtr. 3
Year
* 63% of studies met 90% or more of their recruitment target

20. Network has evolved at 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 – 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
BIG data

25. “Big data’s potential in pharmaceutical R&D is enormous
“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 the individual investigator?
Increasing complexity of trials
Need for speed and delivery
Tracking patients
Clinical Research Networks provide a better option whether self or organizationally mediated

29. 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…
Focus on how we engage the patient and public in clinical research which can helped drive the performance of the UK across all indices .

30. 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

31. 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

32. Conclusion www.crn.nihr.ac.uk
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:

33. 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