National Industry Event 2014 Delivering life-sciences industry research

National Industry Event 2014
Delivering life-sciences industry research
Martin Gibson, Associate Director for Industry, NIHR Clinical Research Network
Delivering research to make patients,
and the NHS, better
As a clinician
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Patient benefit (sometimes the only way to get the drug)
Personal development (makes you better at the day job)
Publications (a few)
Prestige (often not much)
Pecuniary interest (variable)
Pump-priming (own portfolio)
As an R&D Director
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Patient benefit (and safety)
Professional development (of staff + motivation)
Publications (can stack up in large organisations)
Prestige (more important in some organisations)
Pecuniary interest (can be significant)
Pump-priming (increasingly the only source)
As a CRN or national lead
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Patient benefit (at regional and national this can be large)
Professional workforce (safety + virtuous circle)
Publications (significant – nationally relevant)
Prestige (significant – nationally competitive)
Pecuniary interest (UK plc – inward investment/retention)
Pump-priming (strategic localism)
THE NIHR CLINICAL
RESEARCH NETWORK
Helping the NHS to do research
national system ● local capability ● global delivery
NIHR CRN: Greater Manchester
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One of fifteen regional networks
One of the smallest by population (2.9m) and geography
A budget of ~£18.9m for 2014/15
Hosted by Central Manchester NHS Foundation Trust
12 provider Trusts, 3 mental health trusts, NW ambulance Trust and 14
CCGs
Local Delivery
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Evidence based feasibility
Specialty Lead Support
Explore new opportunities
New Investigator prospects
• NHS
• Life-sciences
Industry
• Coordinating
Centre
• Industry
Operations
Manager
• Industry
Facilitators
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Business Focused
Customer Service
Training & Quality
Single point of contact
Escalation
Greater Manchester
site identification
GM site intelligence
Local performance management
Greater Manchester:
• Get it right from the
start; SSV
• Established
relationships with
research teams, R&D,
support departments,
CRA, Project Manager,
escalation points
• Local performance
meetings with CRN
Senior team every 2
weeks.
• Information systems to
support delivery with key
triggers
Industry Team Contact List
Shared Mail box – [email protected]
Bev Watson
Industry Operations Manager
Sarah Fallon
Research Facilitator
T: 0161 726 8005
M: 07557 804 526
[email protected]ter.ac.uk
Julia Pugh
Research Facilitator
T: 0161 701 5605
M: 07557 804 528
[email protected]
Paul Hedgeland
Business Development Manager
M: 07414 903 703
[email protected]
Helen O’Brien
Feasibility Officer/Research Nurse GM CLRN
Mobile: 07584280559
[email protected]
Hilary Prais
Industry Team Support
Mobile: 07827 887 953
Email: [email protected]
Commercial 550
Academic 2692
MHRA CTA authorisations
Phase 2/3/4
800
700
CTA numbers
600
500
400
300
200
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
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Innovation
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International competition
Demand increasing
New medicines more quickly
Payers
Faster delivery to time and target at reduced cost
Targeted therapies
New trial designs – real world, adaptive
‘Big Data’
FEASIBILITY
RAPID RESULTS
RECRUITMENT
Real world trials using EHRs
Salford Lung Study
RF/FFT/0071/14
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EFFICACY TO EFFECTIVENESS
Gold standard science
to answer specific questions
Evidence representing
medicines in the real world
Randomised Controlled Trials
Effectiveness
Double blind
Double dummy
Strict inclusion criteria
Exclusions
Adherence encouraged
Frequent reviews
Drugs provided
Traditional Efficacy Endpoints
Open label
Broad population
All comers
Set in normal care
No extra review
Drugs prescribed and collected
in usual way
Health Outcome and Utilisation
Endpoints
i.e. Real life
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PROTOCOL OUTLINE
Primary endpoint: Moderate/severe exacerbation (defined by oral steroid
(and/or antibiotic use) +/- hospitalisations )
Secondary endpoints: Serious Pneumonias, Healthcare utilisation,
COPD Assessment Test (CAT)
2800 patients
New Rx open label
• Patients in primary
care, aged 40+
• GP diagnosis of
COPD
• Taking
ICS,LABA,LAMA
alone or in
combination
• Exacerbation in
last 3 years
• Consented
Visit 2
Randomised
Routine
respiratory
review
Device
instruction
CAT
12 months
of normal
care
Visit 6
Routine
respiratory
review
CAT
Existing maintenance Rx, ICS, LABA,LAMA
Constant real-time data collection of all HC interventions/safety monitoring
RF/FFT/0071/14
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DATAFLOW FOR LINKED DATABASE SYSTEM
Apollo
Participating GP
Practices
(3rd party data transfer)
Participating
Pharmacies
(prescriptions)
GraphNet
(3rd party data transfer)
NHS
Information
Centre
(secondary user
service (SUS))
Office for
National
Statistics
(ONS)
(deaths)
Salford CCG
SIR
Linked
Database
System
Participating
Hospitals
SUS
ONS
Exeter
(deaths and
moves)
Exeter
GSK
(anonymised information
only)
GSK
(OCEANS data)
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SOME ACHIEVEMENTS TO DATE
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Over 70 GP practices taking part – in Salford, Trafford and South
Manchester.
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Over 120 “high-street” pharmacies involved in Salford, Trafford
and South Manchester.
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Over 2000 GP and pharmacy staff involved fully trained in Good
Clinical Practice.
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Purpose designed eCRF and monitoring IT system built and
operating for over 2 years
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Hospital safety team established and working over 2 hospitals.
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Over 100 nurses and facilitators in the community team
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The sense of ‘can do’ and collaboration between partners
RF/FFT/0071/14
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Summary
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The NIHR Clinical Research Network
– A national system delivering local capability
– Performance managed
– Successful
Innovation
– Adaptive
– Flexible
– Cutting edge
Cannot work in isolation
– Collaborative
– Customer focused