The National Institute for Health Research (NIHR)

Supporting Evidence Generation For MedTech Dr Louise Wood Director, Science, Research & Evidence Department of Health @klouisewood

Adopting MedTech for Patient Benefit, Newcastle Friday 3 March 2017

As life expectancy increases disability increases : all countries, UK highlighted (GBD 2013)

MedTech developers - NIHR can help • Is there a need for your technology? • Find users/patients help improve design • Where does your technology best fit into patient care pathways? • Who are the key opinion leaders and rising stars in the field? • What clinical evidence will be needed to help in adoption? • Help in managing timelines • Who can help design and deliver my study?

NIHR MedTech Offer • Broad range of expertise, capabilities and infrastructure • Voice of users/patients and clinicians NIHR-funded Research Programmes. MedTech research within collaborative studies between the NHS, universities and industry. Industry act as lead or coapplicant. • Efficacy and Mechanism Evaluation (EME). • NIHR Invention for Innovation (i4i). • The NIHR Research Infrastructure • Support with access via NOCRI and Clinical Research Network Coordinating Centre

NIHR: A Health Research System Faculty Investigators & Trainees Senior Investigators

Infrastructure

Universities

Clinical Research Facilities, Centres & Units

NHS Trusts Patients & Public

Clinical Research Networks

Associates

Research Research Projects & Programmes

Research Schools

Research Management Systems

Research Information Systems

Systems

Patients and the Public – central to NIHR’s mission 97% of the public believe it’s important the NHS supports research into new treatments Source: Ipsos MORI poll (June 2012) commissioned by the Association of Medical Research Charities, Breast Cancer Campaign and the British Heart Foundation

RAND Europe report – May 2016 The NIHR is: •

Delivering benefits to patients

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Improving the health of the public nationally and internationally

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Making the nation’s healthcare system more effective, cost-effective and safer

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Putting patients and the public at the heart of research

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Supporting research infrastructure in the NHS and inward investment.

The innovation landscape NIHR Infrastructure CRN, Healthcare Technology Co-operatives (HTCs), DECs

NIHR Infrastructure BRCs, BRUs, CRFs

MRC Programmes

NIHR Infrastructure CLAHRCs

NIHR Programmes

INVENTION

AHSCs

EVALUATION

NHS Patient Care

ADOPTION

AHSNs

NHS Patient Care

DIFFUSION

NIHR Clinical Research Infrastructure Invention

Evaluation

Adoption

Biomedical Research Centres Experimental Cancer Medicine Centres Clinical Research Facilities Patient Safety Translational Research Centres Medtech and In vitro diagnostics Co-operatives Collaborations for Leadership in Applied Health Research and Care Clinical Research Network

NIHR-Supported Facilities NIHR Biomedical Research Units

Newcastle

NIHR Health Protection Research Units NIHR Biomedical Research Centres Leeds

NIHR Blood and Transplant Research Units

Bradford

NIHR Healthcare Technology Co-operatives

Manchester

NIHR Diagnostic Evidence Co-operatives

Sheffield

NIHR-supported Clinical Research Facilities

Liverpool

NIHR School for Public Health Research

Nottingham

Birmingham

Cambridge

NIHR School for Primary Care Research Leicester

NIHR/CR-UK Experimental Cancer Medicine Centres

Oxford Bristol

NIHR Surgical Reconstruction and Microbiology Research Centre

London

NIHR Collaborations for Leadership in Applied Health Research and Care

Brighton Southampton Peninsula

Exeter

9

NIHR Clinical Research Network Service summary

FEASIBILITY Manage and deliver: • Early Feedback • Site Intelligence • Site Identification

COMMERCIAL COSTING TEMPLATES • Support use • Manage templates • Trust, Primary Care & Device versions

Feasibility

HRA APPROVALS SYSTEM FOR GAINING NHS PERMISSION • Support use

Set-up

MODEL AGREEMENTS

STUDY MANAGEMENT

• Support use

• Collect & collate data • Performance manage study

Delivery Clinical Research Network

MRC / NIHR Efficacy and Mechanism Evaluation (EME) • Jointly funded by NIHR and MRC and managed by NIHR. • Supports and encourages academics and clinicians to work with commercial organisations, in particular SMEs.

• Actively supports the translational pull through of promising interventions, with significant potential to benefit patients and the NHS in the medium to longer term. • Funds science driven clinical efficacy studies to test interventions and provides the opportunity to explore disease or treatment mechanisms, which may in turn lead to improvements in health and patient care.

NIHR Invention 4 Innovation (i4i) • Designed to translate healthcare technologies into patient benefit for the NHS with end user pull • Beyond basic research moving technologies towards investor readiness • i4i aims to advance the R&D of innovative healthcare technologies and their translation into the clinical environment for the benefit of patients by: • guiding the progression of innovative medical product prototypes, and • providing business advice to the medical technology professionals it funds.

• Provides funding for collaborative projects involving academics, clinicians and companies.

Experimental Medicine - NIHR BRC Alzheimer’s Plasma Biomarker Study • The NIHR Maudsley Biomedical Research Centre for Mental Health, in collaboration with Proteome Sciences and Merck Millipore, successfully concluded a 1,000 sample Alzheimer’s disease biomarker validation study. • Preliminary data suggest that blood protein biomarkers could help to identify dementia in preclinical phase, or to predict progression from mild cognitive impairment to dementia.

Experimental Medicine NIHR CRF “Bionic Eye” Trial • NIHR CRF trial an electronic artificial retina to restore central vision. • Trial is on-going, but Second Sight Argus II results could be lifechanging for the 500,000 people in the UK affected by AMD. • An 80 year old man from Manchester was the world’s first patient to undergo a procedure and is “delighted” that he can see the faces of his family and watch television in more detail.

National Network of NIHR Healthcare Technology Cooperatives

NIHR Healthcare Technology Co-operatives (HTCs) in the news

Innovative new collar to end MND patients’ neck distress Robotic system for Transoesophageal Echo in heart operations One of the HTC funded project on the Robotic assistance system in the trans-oesophageal echo operating environment has demonstrated improvement on the safety and efficacy of the procedure. This project was selected for an oral presentation at the World Extreme Medicine Expo 2015.

HTC helps develop ‘handsfree’ bowel cancer screening

Wound care – better visualisation • Fuel3D camera provides much more information than a standard camera including wound size, depth, volume and colour indicative of type of tissue. • In partnership with Fuel 3D, NIHR WoundTec HTC helped secure a successful grant application of £685,000 NHS England Small Business Research Initiative (SBRI) fund to increase the functionality of the camera.

• NIHR WoundTec HTC is supporting the testing and evaluation phase of the updated Eyekona camera system.

NIHR HTC Collaborations with industry

Diagnostics Evidence Co-operatives (DECs)

• Act as a catalyst for the generation of high-quality evidence of clinical validity, clinical utility, cost effectiveness and care pathway benefits of commercially-supplied IVDs.

NIHR DECs – Case examples • Newcastle DEC – Evaluated the clinical performance and budget impact of an influenza near patient test in different hospital settings. (Alere) • Analysis of the health economic implications of screening high risk patients with a new test for Carbapenemase producing Enterobacteriaceae. (Renishaw Diagnostics Ltd) • Imperial DEC – Generating evidence through assessment of a new enzymatic test to help with nasogastric tube placement using the diagnostic toolkit methodology they have developed. (Ingenza) • Leeds DEC – Collaborating with clinical academics and industrial partners to evaluate new diagnostic tests to improve the management of patients with Scleroderma and Raynaud’s Phenomenon.

NIHR DECs and SBRI • 10 diagnostics companies secured nearly £2 million funding by working with NIHR DECs in an Innovate UK Stratified Medicine SBRI competition. • Innovate UK provided funding for the development of new diagnostic products and services for use in stratified medicine. • NOCRI worked with Innovate UK to shape the competition and to help companies partner with the NIHR Diagnostic Evidence Co-operatives (DECs) to submit joint applications.

NIHR Medtech and In vitro diagnostic Cooperatives (MICs) • Funding for – the development of medical technologies in areas of high patient morbidity and – evidence for diagnostic tests leading to benefits in healthcare services and the quality of life of NHS patients. • Open competition was launched in November and the funding of £14.25m over 5 years will be available from 1 January 2018.

100,000 genomes project Building a genomic medicine infrastructure • •

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Illumina - NHS Genomic Medicine Sequencing Centre in Hinxton UK Data Infrastructure for Genomic Medicine (with MRC) NIHR National Biosample Centre - £24 million state-of-the-art facility to store the samples 13 NHS Genomic Medicine Centres in England to enrol, validate and feedback to patients Genomics England GeCIP

The MRC-NIHR National Phenome Centre: a National Health Research Resource

Building on 10 remarkable years •

The extraordinary advances in health are based on evidence and science, properly applied.

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Most health interventions depend on science from multiple disciplines from the most basic to the most applied.

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Future advances need to take account of changing need, new threats, new scientific opportunities.

Population 85 and over: 1992, 2015, 2033 (ONS).

Northumberland and Newcastle 2037

The upward movement in age not just mortality and morbidity but also activity.

Age-standardised mortality rates England and Wales (ONS 2014)

0.0

Year

Source: cruk.org/cancerstats 20

Year 0

Year

2014

2012

2010

2008

2006

2004

2002

2000

1998

1996

1994

1992

1990

1988

25

1986

30

1984

4

1982

Breast cancer mortality trend (UK)

1980

35

Rates per 100,000

40

2014

2012

2010

2008

2006

2004

2002

2000

1998

1996

1994

1992

1990

1988

1986

1984

45

1982

Testicular cancer mortality trend (UK)

1980

0.5

Rates per 100,000

1.0

2014

2012

2010

2008

2006

2004

2002

2000

1998

1996

1994

1992

1990

1988

2030

2028

2026

2024

2022

2020

2018

2016

2014

2012

2010

2008

2006

2004

2002

2000

1998

1996

1994

1992

1990

1988

1986

1984

1982

1980

1978

1976

1974

1972

0

1986

1984

1982

1.5

1980

Rate per 100,000

Rate per 100,000

UK cancer mortality projections, all cancers Cancer mortality projections for all cancers combined (UK)

400

300

200

100

Year Malignant melanoma mortality trend (UK)

3

2

1

Stroke mortality in UK: age-standardised mortality / 100,000 population 1969-2013

Source: BHF data

New strokes down, deaths from stroke down, stroke survivors up •

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In the UK, stroke incidence rates (new strokes) have decreased by 19% from 1990 to 2010 Stroke mortality rates have decreased by 46% from 1990 to 2010 in the UK More are surviving Total stroke prevalence (people living with stroke) has increased by 28% from 2005 to 2015 in the UK Not evenly distributed

Stroke prevalence, London 2012/13, StatAnalysis data from QOF

Around 820,000 UK people affected dementia 2016 on current projections (Prince et al 2015)

Conclusions • Increasing demand for MedTech to support patient independence, quality of life and dignity. • Key role in increasing effectiveness, efficiency and sustainability of NHS. • Massive potential for digital and AI – but also hype. • Evidence is necessary (but not sufficient) for adoption. • NIHR can (and wants to) help.

To work with the NIHR infrastructure contact the team at: [email protected]

NIHR Clinical Research Network • For support in undertaking clinical trials in the NHS Contact the NIHR Clinical Research Network Support Team at: • Email: [email protected]

• Tel: +44 (0)113 34 34 555 • Web: www.supportmystudy.nihr.ac.uk

The National Institute for Health Research (NIHR)

Supporting Evidence Generation For MedTech Dr Louise Wood Director, Science, Research and Evidence Department of Health @klouisewood Adopting MedTech for Patient Benefit, Newcastle Friday 3 March 2017