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Delivering Clinical Trials
in the UK NHS
National Institute for Health Research
Mr Ravi Chana
NOCRI
The UK National Health Service (NHS)
NOCRI
The NHS
3
Launched 1948
Free at the point of use for UK
residents (currently more than 63.2
million people)
largest publicly funded health
service in the world
covers everything from antenatal
screening and routine treatments
for long-term conditions, to
transplants, emergency treatment
and end-of-life care
The NHS deals with over 1 million
patients every 36 hours
NOCRI
UK Landscape
Political commitment to supporting life-sciences industry
Health & Social Care Act 2012 / NHS Constitution 2013
Embed clinical research in all aspects of care
NOCRI
The National Institute for Health Research (NIHR)
Funded by the Department of Health to improve
the health and wealth of the nation through
research.
Key role in the Governments strategy for
economic growth
Attracting investment by the life-sciences
industries through its world-class infrastructure
for health research
Most integrated health research system in the
world
Research arm of the NHS.
The NIHR
The NIHR Infrastructure
NOCRI
NIHR INFRASTRUCTURE TO SUPPORT RESEARCH
NOCRI SUPPORTING COLLABORATION
Overview What to expect
MODELS FOR EFFECTIVE PARTNERSHIP
SUMMARY
NOCRI
Structure of the NIHR System
Universities
NHS Trusts
Patients & Public
Senior Investigators
Investigators Associates Trainees
Faculty
Systems
Research Information Faster Easier Clinical Research
Res
earc
h
Res
earc
h
Pro
gram
mes
R
esea
rch
Sch
oo
ls
Clin
ical
Res
earc
h
Net
wo
rk
Infr
astr
uct
ure
Clin
ical
Res
earc
h
Faci
litie
s, C
entr
es
and
Un
its
The NIHR manages its health research
activities through four main work strands:
Infrastructure: providing the facilities
and the people to conduct first-class
research
Research: commissioning and
funding research to generate innovative
new healthcare solutions.
Faculty: supporting the individuals
carrying out and participating in research.
Systems: promoting faster, easier
clinical research through unified,
streamlined and simple systems for
managing ethical research and its outputs.
NOCRI
NIHR Research Infrastructure
Invention Evaluation
> 0.5 billion p.a. investment in
relevant infrastructure to
support clinical research at all
points in development pipeline
Innovation
Late-phase clinical
research
NIHR Biomedical Research Centres
Early-phase clinical research
Evaluation Adoption
NIHR Biomedical Research Units
NIHR Clinical Research Facilities
Experimental Cancer Medicine Centres
NIHR Clinical Research Network
Healthcare Technology Cooperatives
Diagnostic Evidence Cooperatives
NIHR Collaborations for Leadership in
Applied Health Research & Care
NIHR Biomedical Research Centres Newcastle Oxford Cambridge Southampton Imperial UCLH Great Ormond St Moorfields Guys and St Thomas Royal Marsden South London and Maudsley
NIHR Healthcare Technology Co-operatives Birmingham Bradford Leeds Nottingham Sheffield Barts Cambridge Guys & St Thomas
NIHR Biomedical Research Units Newcastle dementia Leeds musculoskeletal Central Manchester musculoskeletal Liverpool gastrointestinal Nottingham hearing/respiratory/gastrointestinal Leicester cardiovascular/respiratory/nutrition Birmingham gastrointestinal Bristol cardiovascular/nutrition Oxford musculoskeletal Southampton respiratory London Imperial cardiovascular/respiratory Barts cardiovascular UCL dementia South London and Maudsley - dementia
NIHR-supported Clinical Research Facilities Alder Hay Childrens Brighton and Sussex Cambridge Central Manchester The Christie South Manchester Newcastle Leeds Oxford Royal Devon and Exeter Sheffield Birmingham Southampton Royal Marsden Guys and St Thomas Imperial Moorfields South London and Maudsley UCL
NIHR-Supported Facilities
NIHR Diagnostic Evidence Co-operatives Imperial Leeds Newcastle Oxford
NIHR Experimental Cancer Medicine Centres Birmingham Cambridge Cardiff Leeds Leicester Barts/ Brighton ICR Imperial Kings College London UCL Manchester Newcastle Oxford Sheffield Southampton
NIHR Collaborations for Leadership in Applied Health Research and Care
East of England
East Midlands
Greater Manchester
North Thames
North West Coast
North West London
Oxford
South London
South West Peninsula
West
West Midlands
Wessex
Yorkshire and Humber
Newcastle
Leeds
Sheffield
Leicester
Oxford
Bristol
Brighton
Peninsula
London
Bradford
Manchester
Liverpool
Exeter
Southampton
Cambridge
Nottingham
Birmingham
NOCRI
NIHR Biomedical Research Centres (BRCs)
Imperial
Southampton
Oxford
Guys and St Thomas
Marsden*
Cambridge
Maudsley*
Newcastle upon Tyne
University College
Moorfields*
Great Ormond St*
> 800million Government
investment to support
NIHR Centres and Units -
the largest ever
commitment to early stage
health research
http://www.google.co.uk/url?sa=i&rct=j&q=nhs+uk+map&source=images&cd=&cad=rja&docid=8DUWWYQEtlPVOM&tbnid=MEY5kKq19tpUuM:&ved=0CAUQjRw&url=http://www.surgeryrecruitment.nhs.uk/&ei=cYzBUfWRK4WqOtOxgegE&bvm=bv.47883778,d.ZG4&psig=AFQjCNH6a144VknCEqrx3kpTLa1g1wLtWw&ust=1371725224297846
NOCRI
NIHR Biomedical Research Units (BRUs)
Nottingham
Hearing
Gastrointestinal
Southampton
Respiratory
Oxford
Musculoskeletal
Barts & London
Cardiovascular
Bristol
Cardiovascular
Nutrition, Diet, Lifestyle
Cambridge
Dementia
Maudsley
Dementia
Newcastle upon Tyne -
Dementia
Leicester
Cardiovascular
Respiratory
Nutrition, Diet, Lifestyle
Imperial
Cardiovascular
Respiratory
University College
Dementia
Liverpool
Gastrointestinal
Manchester
Musculoskeletal
Leeds
Musculoskeletal
Birmingham
Gastrointestinal
http://www.google.co.uk/url?sa=i&rct=j&q=nhs+uk+map&source=images&cd=&cad=rja&docid=8DUWWYQEtlPVOM&tbnid=MEY5kKq19tpUuM:&ved=0CAUQjRw&url=http://www.surgeryrecruitment.nhs.uk/&ei=cYzBUfWRK4WqOtOxgegE&bvm=bv.47883778,d.ZG4&psig=AFQjCNH6a144VknCEqrx3kpTLa1g1wLtWw&ust=1371725224297846
NOCRI
NIHR Experimental Cancer Medicine Centres
Translational Research network
launched in 2007
Discovery of new biomarkers and cancer
treatments
Jointly funded by CR-UK and UK Health
departments (NIHR in England)
Key areas
Target mechanisms and pathway expertise
Preclinical models, biomarkers and
pharmacodynamic endpoints
Early phase trials
Stratified medicine and screened patients
Combination therapies
Regulatory requirements
The NIHR Translational Research Partnerships (TRPs)
NOCRI
NIHR Translational Research Partnerships
(TRPs)
2010/11 UK Life Sciences Strategy and Plan for Growth
Industry ask for improved access to experimental medicine and translational research in the UK
TRPs established in October 2011
Ready-to-go collaborative networks for experimental medicine and first-in-disease studies with industry
Inflammatory Respiratory Diseases
Joint & Related Inflammatory Diseases
Formal Collaboration Agreement signed by TRP centres
Common business principles and practices
Governance structure
NDA and mICRA templates agreed and readily available
NOCRI
NIHR Joint & Related Inflammatory Disease
TRP
Centres and Academic Leads
Prof John Isaacs Newcastle
Dr Natasha Jordan Cambridge
Prof Ian Bruce Manchester
Prof Peter Taylor Oxford
Prof Matthew Pickering
London (Imperial)
Prof Andy Cope London
(KCL)
Prof Cos Pitzalis London (QMUL)
Prof David Isenberg London (UCL)
Prof Chris Buckley Birmingham
World-class expertise and
capabilities in experimental
medicine
Outstanding science
Patient cohorts
Study delivery
Exclusive focus on industry
collaborations
NOCRI provides single point of
contact and operational support
Internationally unique
Disease scope:
Rheumatoid Arthritis, Sjogrens Syndrome, Lupus, Psoriatic Arthritis, Ankylosing Spondylitis, Vasculitis
NOCRI
NIHR Inflammatory Respiratory Disease TRP
Centres and Academic Leads
Prof. Ratko Djukanovic
Southampton
Prof. Peter Barnes London
(Imperial/Brompton)
Dr Lorcan McGarvey Belfast
Dr Ling-Pei Ho Oxford
Dr Tim Harrison Nottingham
Dr Joanna Porter London (UCL)
Dr Bibekbrata Gooptu London
(KCL)
Prof. Chris Brightling Leicester
Dr David Singh Manchester
World-class expertise and
capabilities in experimental
medicine
Outstanding science
Patient cohorts
Study delivery
Exclusive focus on industry
collaborations
NOCRI provides single point of
contact and operational support
Internationally unique
Disease scope:
Asthma, COPD, Chronic Cough, Interstitial Lung Disease, Cystic Fibrosis and other rare lung diseases
NOCRI
TRP Strategic Priorities
1. Partnership with industry:
Collaboration and scientific exchange essential
Will consider commercial contracts where TRP provides scientific
leadership
2. Experimental medicine:
In depth phenotyping studies
Early phase interventional studies of new therapeutics: proof of
mechanism, proof of concept
Stratification studies
3. Academic value:
Data rich outputs breaking new ground in the assessment of disease
and treatments
4. Delivery
Quality; recruitment to time and target
NOCRI
NOCRI
Belfast
Oxford
Imperial
Birmingham
Southampton
Nottingham
Leicester
Kings College
Manchester
Newcastle
Barts & London
Cambridge
University College
London
36 NHS Trusts and
University partners Single point of
contact for industry
Operational Management
Speed
Quality
Operational Advantages of the TRPs
http://upload.wikimedia.org/wikipedia/en/e/e4/CPRE_England_tranquillity_map.jpghttp://upload.wikimedia.org/wikipedia/en/e/e4/CPRE_England_tranquillity_map.jpghttp://upload.wikimedia.org/wikipedia/en/e/e4/CPRE_England_tranquillity_map.jpghttp://upload.wikimedia.org/wikipedia/en/e/e4/CPRE_England_tranquillity_map.jpg
NOCRI
Flexible Collaboration
Industry Led
Collaboration
Contract
Commercial
Research
Academic
Research
Academic Led
Collaboration
Industry Collaborative Research
Each party contributes materially and intellectually and shares liabilities, IP ownership and rewards according to the relevance of their contribution
Model templates for research collaborations (mICRA) and contract research (mCTA)
Current TRP Project Portfolio
Pro
ject S
tart D
ate
2013/14
2H15
2016
Completed
Studies
Study setup
& contract Exploratory discussions (study design)
Active
Studies
Academia-sponsored
Industry-sponsored
>12M industry investment realised
1H15
RA
MoA
Early RA
ExpMed
Sjogrens
PhIb
Lupus
Pre-clin
Sjogrens
Pre-clin
Lupus
StratMed Sjogrens
PhIb
Sjogrens
Pre-clin
Tralokinumab in severe asthma
(MESOS - AstraZeneca)
Stratification study:
Biological drug for severe asthma (Novartis)
COPD/CF
Diagnostic
COPD
PhII
Asthma
MoA/PhI
I
Asthma
StratMed Asthma
PhIIa
Asthma
/COPD
PhIIa
Asthma
MoA
Asthma
Pre-clin
Asthma
Pre-clin
IPF
DDI
Ph2a PoC study
(Novartis)
Prevention study:
Abatacept in pre-RA
(APIPPRA - BMS)
Biomarkers for inadequate
response to anti-TNF
(THERAPIST - Janssen)
Respiratory TRP
Joint Inflamm TRP
NOCRI
Current TRP projects and partnerships
with Novartis
NOCRI
THERAPIST (J-TRP)
8 TRP sites, single collaboration agreement, 18 months recruitment period
Recruited 42/50 patients by June 2016
2014 Oct Nov Dec Jan 2015 Feb Mar 2015
Lead site "green lighted"
2/3/2015
Final Sponsorship Approval (QMUL) 9/2/2015
REC Approval
5/2/2015
REC Submission 7/11/2014
Collaboration Agreement executed 28/10/2014
13/2/2015
NHS Permission Barts Health (lead site)
TRP study delivery
NOCRI
TRP summary
TRPs uniquely placed to tackle challenges of early phase
clinical development in collaboration with industry
Understanding of disease mechanisms and biomarkers combined with cutting
edge capabilities ensures optimal study design
Well characterised patient cohorts for optimally designed PoC studies
Operational support from NOCRI, including contractual agreements and
templates endorsed by BIA, ABPI and all TRP centres
Strong industry traction and project portfolio established
First industry collaborative multi-site study underpinned by a single contractual
process and agreement
Strong portfolios in Asthma, Rheumatoid Arthritis and Sjogrens Syndrome
Additional opportunities for TRPs in COPD, IPF and Lupus
NOCRI
Translational Research Collaborations (TRCs)
NIHR Translational Research Collaboration in Dementia
Formed by NIHR Dementia BRUs and six NIHR BRCs with dementia related
research themes
Deep & Frequent Phenotyping study
Biomarker study in Parkinsons Disease
NIHR Translational Research Collaboration in Rare Diseases
Brings together translational research expertise and facilities in rare diseases
14 therapeutic areas, with a focus on deep phenotyping of rare disease patient
cohorts (currently >40 different rare diseases)
Successful 2015 call for industry collaborative projects:
30 expressions of interest, 14 full applications, 9 funded
Leveraged industry funding of ~1.3M
Projects include a Ph2a trial of Actemra (anti-IL6R) in PAH
NIHR Cancer and Nutrition Collaboration
Scoping areas for industry engagement
NOCRI
To work with the NIHR
infrastructure contact the
team at:
How to engage
mailto:[email protected]