1. Professor Dame Sally C. Davies FRS FMedSci
Building the NIHR
NIHR: 10 years of delivering health
and care research for the nation
QEII Centre, London
Wednesday 18 May 2016
Professor Dame Sally C. Davies FRS FMedSci
Chief Medical Officer
Department of Health

2. Why is the Government committed to research in the NHS?
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. Getting it right and sign up
New Government Strategy 2006
Recognition of barriers & Consultation 2005

4. What were the challenges 10 years ago?
Dramatic fall in numbers
of clinical academics
Difficulty in developing sustainable capacity
Problems with career paths for
all professions in research
Patients
NHS
Universities
NHS R&D funding was allocated on a historical basis
Perception that applied health research was second class
A mixed research culture
in the NHS
Low applied evidence base
Insufficient translational research
Insufficient industry engagement
Insufficient patient engagement in research
Inadequate systems to promote and support research
NHS R&D funding was locked into historical allocations
A mixed research culture in the NHS
Dramatic fall in numbers of clinical academics
Problems with research career paths for all professions
Perception that applied health research was second class
Low applied evidence base
Insufficient patient engagement in research
Inadequate systems to promote and support research
Insufficient translation: basic to applied; applied to patients
Insufficient industry engagement
Insufficient strategic co-ordination between funders

5. Where we came from Funding for research 2005-06
National Research Programmes £150m
Support for Science £400m
Priorities and Needs £100m
Hospitals

6. Patients and public at the centre
What we did:
Patients and public at the centre
Patients & Public
Universities
NHS Trusts

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

8. Impact: Clinical trials funded by the NIHR HTA programme

9. 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
Funder: NIHR HTA Programme 09/102/01 CRASH 2
Start date: October 2009 Publication date: March 2012
Cost: £105,314
Chief Investigator: Dr Pablo Perel
Contractor: London School of Hygiene and Tropical medicine
Tranexamic acid reduces the risk of bleeding to death by 30% if administered within the first hour of injury and by 20% if administered within the first three hours. In October 2012 NICE has provided an evidence summary for use of tranexamic acid in significant haemorrhage following trauma which states that death due to bleeding was reduced if tranexamic acid was administered up to 3 hours from injury. However, death due to bleeding seemed to increase with administration later than 3 hours after injury. A health economic analysis has found that tranexamic acid for the prevention and treatment of significant haemorrhage in trauma patients has an incremental cost of $64 international dollars (£43) per life saved. Findings from this study have influenced practice in the NHS, UK Armed Forces and beyond. NICE Clinical Guidance on Major Trauma is expected to be published in February In addition, the possible benefits of tranexamic acid in other situations are being explored through further research (HTA project 09/102/01
a nested randomised, placebo-controlled trial
274 hospitals in 40 countries were involved

10. Impact: Bronchiolitis of Infancy Discharge Study (BIDS)
Treating infants with bronchiolitis using a lower level of supplemented oxygen saturation is just as safe and effective as a higher oxygen level, as well as being cheaper.
Judges from the BMJ Awards said:
“With this study, defining oxygen saturation targets with bronchiolitis can finally move from opinion based evidence to medicine. The study is elegantly designed and brings robust evidence to treatments decisions concerning one of the most common causes of hospital admissions in infants”.
The award recognises original UK research published in the past year with the greatest potential to significantly improve health and healthcare
5 May 2016
This NIHR HTS-funded trial has just won the BMJ Award for research paper of the year
What they did: Bronchiolitis is a common infection in infants. A minority require admission to hospital, where oxygen levels are monitored and supplemental oxygen provided to those who fall below an oxygen saturation threshold. The question is: where should that threshold lie?
Professor Steve Cunningham of the Department of Child Life and Health at Edinburgh University and colleagues designed a double-blind trial in which infants were randomised to targets of 90% or 94% oxygen saturation. “We wanted to know what it means in terms of outcomes if you go for 90% rather than 94%/. The other question is what does it mean for services?”
The answer is that there is no clinical difference. Time to resolution of cough – the primary outcome – was the same in both groups. £The other outcomes were better in the lower oxygen group” he says. “the kids started feeding sooner and the parents’ perception was that the kids got better sooner”. This suggests that higher oxygen levels may be detrimental.
The findings have service implications, because they mean that fewer patients will require supplemental oxygen and in those who do the time it is needed is reduced from 27.6 hours to 5.7 hours. For paediatric hospitals bronchiolitis is a huge issue every winter – “There’s a six-week period, between mid-November and the endo of December, when the whole thing is gridlocked” he says. A lower oxygen threshold can reduce that pressure and in future may enable oxygen at home rather than in hospital.
The team received the award at the BMJ awards on the 9th May. The project was funded by the NIHR Health Technology Assessment Programme.

11. Impact: NIHR Research Professors

12. Impact: Leveraged funding from the NIHR BRCs / BRUs

13. Impact: CRN recruitment
This slide shows patient recruitment to CRN portfolio studies by financial year.
Provisional data indicate that in 2015/16 approximately 600,000 participants entered over 5,000 clinical research studies supported by the NIHR Clinical Research Network

14. 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
HRA Approval completed its roll-out on schedule on 31 March as the route for applying for approval to conduct research in the NHS in England. It is still early days and we are keen to receive early feedback to refine processes.
A key aim is to simplify the approvals process instead of separate (and sometimes siloed) REC and R&D review processes. The data here shows that we have good timelines for REC review (well within the statutory 60 days for clinical trials). HRA Approval includes the REC review, and the data here shows the overall times to issue HRA Approval for the early studies we have processed so far. This data shows overall times, including the time taken for the applicant to respond to queries. Proportionality is built in to the process so that many straight forward studies have been approved within one month.
HRA Approval is designed so that sites can be set up in parallel and ready to start once HRA Approval is issued. The HRA’s remit gives it an authority that allows consistency to be built in, in a way that was difficult previously. We are hearing positive support from many in NHS R&D who are keen to focus on supporting study set-up and delivery.
HRA Approval is a key step in our preparation for the implementation of the Clinical Trial Regulation in We already have a well-organised REC system (unlike many other countries) and through HRA Approval are putting in place the building blocks for the coordination needed for a single member state opinion. Removing what has often been regarded as the ‘additional step’ of applications to local R&D aligns us with the principles of the single application in the regulation.

15. Impact: Delivering studies in the NHS

16. Impact: Clinical Practice Research Datalink
1.8 billion consultations
Drug exposure
Diagnoses and symptoms
Referrals
Laboratory tests
Vaccination history
Demographic data
A longitudinal database of anonymised routine primary care records
Includes 21 million patient lives collected over 25 years
600 currently contributing GP practices
> 5 million patients registered at contributing GP practices (1 in every 12 people in the UK)
Services to support observational and interventional research using real world data
What is CPRD?
A longitudinal database of anonymised UK healthcare records providing interventional and observational research services
CPRD’s mission is to:
improve public health
facilitate innovation – increase efficiency of clinical trials
enable academic and industry research in the UK and globally
support UK growth.

17. Impact: Clinical Practice Research Datalink
CPRD holds data on 21 million patient lives
2014/15: 223 studies were approved
2015/16: 229 studies were approved
Many NICE guidelines are based on evidence from CPRD enabled research
Over 1600 peer-reviewed publications have arisen from research using CPRD data
CPRD has over 70 UK and international academic, Government and industry clients
CPRD holds anonymised primary care records of 1 in 12 people in the UK

18. Global performance of the UK research base
Source: Our plan for growth: Science and Innovation. Department of Business, Innovation and Skills. December 2014.

19. Clinical academic careers
Total headcount has increased since 2006 (NIHR establishment)
However:
There has been a reduction in Reader/Senior Lecturer numbers
The number of NHS consultants has markedly expanded, so proportion going into academia has decreased
Source: Medical Schools Council survey of staffing levels of medical Clinical Academics in UK medical schools (31 July 2013) * *

20. Progress
This slide shows how the funding for NIHR programmes has grown

21. Impact: Money

22. The people who made it happen

23. RAND Europe report – published today
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
The report summarises the impacts and benefits of the NIHR’s support for clinical, applied health and social care research and research infrastructure across 100 case studies, clustered across 10 themes of delivery, collaboration and achievement.
The examples in these case studies illustrate that the NIHR is undertaking world-class research, as well as supporting, enabling and delivering research through its partners. Specifically, it shows that the NIHR supports research that is:
Delivering benefits to patients. The NIHR is developing innovations that can be delivered throughout the health and social care system, such as more personalised and cost-effective dementia care, the first ever implant of a fully synthetic trachea, new treatments for breast cancer and dedicated partnerships to support research in rare disease areas.
Improving the health of the public nationally and internationally. NIHR-supported public health research is leading to reductions in alcohol-related harm, improving smoking prevention strategies and increasing vaccination coverage for H1N1 and childhood immunisation. Worldwide, more than 1 million people stand to benefit from NIHR-funded research into the off-label use of tranexamic acid to aid clotting during traumatic bleeding.
Making the nation’s healthcare system more effective, cost-effective and safer. NIHR-funded research into patient safety has informed the World Health Organization’s (WHO) Surgical Safety Checklist, which is significantly reducing post-operative complications. Other research is identifying areas for cost-effective solutions that save money in areas ranging from physical therapy, to dementia, to diabetes.
Putting patients and the public at the heart of research. The NIHR is a world leader in patient and public involvement, and there have been tangible improvements to how research is able to deliver patient benefit. INVOLVE, the NIHR-funded national public involvement centre and advisory group, helps ensure that patients and the public are effectively involved at all stages of research studies, making them more acceptable and meaningful for research users of all ages.
Supporting a research infrastructure in the NHS. The NIHR supports a national research infrastructure of world-class research centres, units and facilities, as well as the Clinical Research Network. Together these provide coverage across the health research system in England and enable and facilitate both research funded by the NIHR itself and research funded through other government funders, charities and industry. In 2014–15, from an initial investment of £227.8 million, the NIHR research infrastructure leveraged £1.06 billion in research funding from the NIHR’s public, charity and industry research funding partners.

24. Professor Dame Sally C. Davies FRS FMedSci
Building the NIHR
NIHR: 10 years of delivering health
and care research for the nation
QEII Centre, London
Wednesday 18 May 2016
Professor Dame Sally C. Davies FRS FMedSci
Chief Medical Officer
Department of Health