Joint working the CRN perspective Professor Oleg Eremin

Joint Working: the CRN
Perspective
Professor Oleg Eremin, Clinical Director | TCLRN, Nottingham University
Hospitals NHS Trust

Trent Comprehensive Local Research Network
Clinical Research Network
JOINT WORKING :
THE CLRN PERSPECTIVE
Professor Oleg Eremin
Clinical Director
24th May, 2013

One of 25 CLRNs in England, one of 2 in East Midlands.
(established mid 2007)
Has a large population (2.83 x 106) living in large urban
connurbations and large sparsely populated rural counties.
Covers 3 counties [Derbyshire, Lincolnshire and
Nottinghamshire] – large geographical area.
Multiple sites of socio-economic deprivation (many very
deprived).
TRENT CLRN : BACKGROUND

Complex, multidisciplinary organisation with differing service
configurations, clinical priorities and research excellence.
15 NHS Trusts
6 Primary Care Trusts (ceased April 2013)
3 Mental Health Trusts
5 Acute Trusts, Secondary & Tertiary Care
1 East Midlands Ambulance Service
4 Higher Educational Institutions
4 Universities
(Nottingham, Lincoln, Derby, Nottingham-Trent)
6 Topic Specific Research Networks
3 CRNs, SRN, MCRN, MHRN, DRN, DeNDRoN
Primary Care Research Network
TRENT CLRN : BACKGROUND

TRENT CLRN CORE TEAM
Clinical Director: Professor Oleg Eremin
Senior Manager: Janet Boothroyd
Lead RM & G Manager: Sheila O’Malley
Industry Manager: Dan Kumar
Lead Research Nurse: Penny Scardifield
Senior Research Nurse: Ali Raynor
Information Manager: Richard Hart
Senior RM & G Manager: Hannah Finch
Lead Network RM&G Facilitator: Christine Brindley
RM&G Managers: Kelly Rowe, Sue Barklie
Industry Research Officers: Carl Sheppard, Nick Hamilton
Information Coordinators: Dave Papworth, James Fox, James Leatherland
RM&G Facilitators: Alison Thorpe, Karen Asher, Mays Jawad, Ruth Doyle
Administrators: Jenni Dunne, Alex Russell
CSP Coordinators: Rebecca Denton, Simon Squire, Amardeep Sagoo

Clinical Research NetworkTRENT CLRN EXECUTIVE GROUP
Professor Oleg Eremin: Clinical Director, Trent CLRN (Chair)
Mrs Janet Boothroyd: Senior Manager, Trent CLRN
Dr Teresa Grieve: Assistant Director of Research & Development,
Derby Hospitals NHS Foundation Trust
Prof Nick Manning: Professor Social Policy and Sociology
University of Nottingham
Prof Tony Avery: Professor of Primary Care
University of Nottingham
Dr Brian Thomson: Research & Innovation Director
Nottingham University Hospitals NHS Trust

Specialty Group Name
Age & Ageing Dr Tahir Masud
Dr Opinder Sahota
Cardiovascular Dr Justin Cooke
Dermatology Dr Adam Ferguson
Ear Nose Throat Prof Deborah Hall
Gastroenterology Prof Chris Hawkey
Genetics Dr Rachel Harrison
Hepatology Dr Steve Ryder
Injuries and Accidents Dr Frank Coffey
Metabolic & Endocrine
(not diabetes)
Prof Ian MacDonald
Dr Peter Mansell
Musculoskeletal Dr Chris Deighton
Nervous System Disorders Prof Cris Constantinescu
Paediatrics (non medicines) Dr Jon Dorling
Palliative Care Dr Andrew Wilcock
Renal Dr Chris McIntyre
Reproductive Health and
Childbirth
Prof Jim Thornton
Dr George Bugg
Respiratory Prof Alan Knox
Surgery Prof Dileep Lobo

To provide a high quality NHS clinical research
infrastructure and research management and
governance framework.
• Clinical research nurses / officers (secondary and primary care).
• Sessional support for clinicians (all disciplines).
• Service support costs (additional clinical services and diagnostic
tests eg pharmacy, radiology, pathology).
• Implementation of a coordinated system for gaining NHS
permissions (CSP) to ensure, uniform, high quality and expeditious
delivery of research management & governance (RM&G approval).
TRENT CLRN : CORE FUNCTIONS

Operating Framework (2008)
“ … to double the number of patients taking part in clinical
trials/studies over the next five years.”
* [7,500 in 2008 / 09 ---> 21,000 in 2012/13]
Topic Specific Research Networks
Cancer, Stroke, Medicines for Children, Mental Health, Diabetes and
DeNDRoN.
Have received support, where it is lacking or needs extra resource in
specific areas of the network, to achieve optimal research output and
expansion.(Tripartite Working Arrangements).
Primary Care Research Network
Special support has been given to primary care which has been
under-funded centrally.
TRENT CLRN : RESEARCH PRIORITIES

Comprehensive Clinical Research Network
• 17 Local Specialty Groups (SGs) & Leads (12 NUHT, 3
DHFT, 1 CRHFT, 1 EMAST) are a key development.
2 Local Priority Groups : Palliative Care and DeNDRoN.
• 3 National Leads : Dermatology (HW); Surgery (JS);
Hepatology (SR).
Commercial Studies and Trials
• Top priority over the past 2 years
• Established Industry Team (industry manager, 2 support
officers, administrator).
TRENT CLRN : RESEARCH PRIORITIES

• Recruited into 81 Commercial Studies in Trent in
2012/13, 20% increase on 2011/12 total.
• Trent CLRN is ranked top out of 25 CLRNs in
England for recruitment to time & target into CCRN
Commercial Studies that closed in 2012/13 (NIHR
Commercial Activity Report, published 13/5/13).
COMMERCIAL PERFORMANCE IN
THE LAST 12 MONTHS

• Trent CLRN is in the top 9 out of 25 CLRNs in
England („green rated‟) for recruitment into open
Commercial Studies in 2012/13.
• The median time (26 days) for NHS Trust approvals
from receipt of a valid SSI application was rated
„Green’ (below 30 calendar days) for the year
2012/13.
COMMERCIAL PERFORMANCE
IN THE LAST 12 MONTHS

• We work in partnership with our 2 affiliated group
leads and our 17 specialty group leads across a wide
range of disease areas.
• Trent has strong and expanding links with Academia, in
particular, The University of Nottingham (e.g.
neurological sciences, reproductive health)
COMMERCIAL PERFORMANCE
IN THE LAST 12 MONTHS

• Expansion of the Trent CLRN Industry Team by
appointment of an additional Industry Support Officer.
• Focus on robust feasibility and early engagement, and
developing good working relationships with research
teams in Trent.
INDUSTRY STUDIES IN TRENT CLRN:
TOP PRIORITY IN 2012/13

• Performance management and regular audit of
commercial research activity by CLRN.
• Raising the profile of industry studies within NHS Trusts
in Trent.
• Integration with RM&G processes and single point of
escalation.
INDUSTRY STUDIES IN TRENT CLRN:
TOP PRIORITY IN 2012/13

• Emergency Dept: Significant over recruitment in a
difficult setting with a previously commercially naive
research area.
• Hepatology: Key Opinion Leader, National Specialty
Group Lead, extensive database of research ready
patients and with significant commercial trial portfolio
recruiting to time and target.
SUCCESS STORIES AND
KEY DEVELOPMENT AREAS

Clinical Research NetworkSUCCESS STORIES AND
• Ophthalmology: Commercially experienced Investigators
at two Acute Trusts with excellent recruitment records in
difficult to recruit to trials.
• Cardiology: Keen interest across all 5 Acute Trusts with
pro-active Specialty Group Lead and strong track record
of recruitment at the major Trusts.

• Respiratory: Significant patient population due to history
of mining in the region and R&D Lead keen to expand
commercial activity with the use of a newly established
clinical research facility.
• Mental Health Research Network: Provided support to
set up the first commercial CTIMP study at
Nottinghamshire Healthcare NHS Trust; appointment of a
Clinical Lead to drive the agenda forward.
SUCCESS STORIES AND

PRIMARY CARE RESEARCH NETWORK
COLLABORATION
In partnership with the Trent Hub of the Primary Care
Research Network East Midlands and South Yorkshire
(PCRN EMSY), involved in increasing GP participation in
commercially sponsored research – Report in final
stages.

• The primary aim of the project is to identify the
motivation behind and barriers to GP participation in
industry research.
• To develop site profiles for all the GP practices who
agree to participate in this project – sent on to industry
(e.g. Novartis).
• Key opinion leader with track record of recruitment to
time and target.
PRIMARY CARE RESEARCH NETWORK
COLLABORATION

Former mining
area with high
levels of
deprivation
and health
inequalities
Large, disper
sed rural
area
Large
migrant
workforce
High levels of
avoidable mortality
eg
smoking, alcohol, s
elf harm
Highest rate of hip
fractures in
England
Leicester
forecast to be
Britain’s first
‘majority
minority
ethnic’ city by
2012
Zero
deprivation
Top 10% life
expectancy
Corby has lowest
life expectancy in
the region (bottom
5%)
Significant migrant
workforce
EMAHSN Geography – where are we?
Multi-ethnic, diverse, metropolitan
populations in Leicester, Nottingham and
Derby
Stark difference in deprivation, and life
expectancy between the city and county
25

• Trent CLRN Industry Team engaged with East Midlands
AHSN (Carl Edwards) and looking at the ways that we
can work more efficiently and effectively together.
• Trent CLRN Industry Team is working with Carl Edwards
to link into the Industry Advisory Panel, once the Clinical
Research Themes have been finalised and AHSN licence
granted.
WORKING WITH THE ACADEMIC HEALTH
SCIENCE NETWORK

Clinical Research NetworkREAL WORLD DATA AND TRIALS
• The UK’s share of global commercial trial activity has
decreased significantly in the 21st century.
• There are various reasons for this: A slow start
time, poor recruitment to time and target and high costs
for trial activity, compared with other countries (e.g.
Eastern Europe).
• This trend is beginning to reverse and improvements in
numbers of studies and their delivery is occurring in
Trent and the U.K.

REAL WORLD DATA AND TRIALS
• ABPI has suggested a strategy for the U K, ensuring
that clinical trials / studies are done in a timely and cost-
efficient way, namely the use of real world data (RWD).
• Defined as “Data collected outside the controlled
constraints of conventional clinical trials to evaluate
what is happening in normal clinical practice.” (ABPI).
• RWD compliments and augments RCT data and can
improve performance in a range of trial settings.

REAL WORLD DATA AND TRIALS
The NHS is uniquely placed to participate in RWD trials.
• Inclusive national health system free at the point of
entry.
• Patient data (comprehensive, electronic) is held in a
number of different formats and systems in the NHS
(primary care, hospitals, registries, social care).
Opportunity for linking and integrating these systems.
• GP prescribing.

COPD : THE SALFORD LUNG STUDY
• The Salford Lung Study is a world–first “real-life” clinical
effectiveness study.
• Only possible because of Integrated Electronic Record
Data between Primary and Secondary Care.
• An enormous logistical effort: 4232 patients, 50+ GPs, 58
community pharmacies, 50+ community nurses, Hospital
Safety Team and investigations and GSK.
• Will provide important information for clinicians, healthcare
decision makers and most especially patients.
Presented by Prof M Gibson at Trent CLRN Industry Event, March 2013

• Multinational, prospective, observational study in patients with
unresectable or metastatic melanoma with a minimum of 3
years follow-up. (Bristol-Myers Squibb)
• Study is not designed to test any hypothesis and has the
following objectives:
1. To estimate the incidence and severity of adverse reactions
and their management in adult patients treated with
ipilimumab in the post approval setting. (ipilimumab; human
MAb specific for CLA-4 on T cells, potentiating anticancer T
cell responses)
REAL WORLD STUDY IN TRENT (ULHT)

• Study is not designed to test any hypothesis and has the
following objectives:
2. To describe patterns of care for adult patients receiving any
therapy for unresectable or metastatic melanoma.
3. Secondary objectives are to describe real world use of
healthcare resources and overall survival.

Rationale for Global Health Outcomes Objectives:
• To achieve an understanding of physician decision-making in the
treatment of unresectable or metastatic melanoma post launch of
ipilimumab.
• To establish that the clinical benefit observed in the original trial is
comparable to that observed in a real world population.
• To ascertain if the real world prospective data on patterns of
care, health care research utilisation and real world treatment
effectiveness will more reliably inform healthcare providers and
industry about the cost effectiveness and benefits of ipilimumab.

• Clinical research in the UK, in particular, involving
industry studies / trials, is facing significant
challenges in the global market. The NHS in
collaboration with the NIHR is uniquely placed to
pursue a wide range of world class research and to
adapt to the changing global healthcare and industry
initiatives.
SUMMARY

• Trent CLRN is a well established and
resourced, effective and successful Clinical Research
Network, with a strong commitment to support and
implement commercial NIHR approved studies.
• Trent CLRN is in the process of undergoing a
transition, merging with the
Leicestershire, Northamptonshire and Rutland CLRN
into the EMLCRN, within the umbrella of the new
EMAHSN.
SUMMARY

• A top priority for Trent CLRN and the subsequent
EMLCRN in 2014, is to continue to engage actively
and constructively with industry, improve further the
metrics of trial delivery, explore innovative
collaborations (e.g. real world studies) and make EM
the preferred site for commercial studies / trials in the
UK.
Website: http://trent.crncc.nihr.ac.uk
SUMMARY

Joint working the CRN perspective Professor Oleg Eremin

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