Transcript Types of Clinical Research

Dublin Academic
Medical Centre
Developing translational medicine in
Ireland
Bill Powderly MD FRCPI
Dean of Medicine, UCD School of Medicine
Chief Academic Officer,
Dublin Academic Medical Centre
© DAMC 2009
Ireland – small island in global
world
Irish medical landscape 2000
• 5 Medical Schools
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~700 students pa
Small faculty
Limited research.
University rankings low
• Loosely affiliated teaching hospitals
– High quality clinical staff
– 95% trained in USA, UK or Australia
• Beginning of significant Irish government
and philantropic investment in science
infrastructure
Infrastructural Investment
• Commencing in 1998, Irish Government
launched Programme for Research in Third-Level
Institutions (PRTLI)
• €1.22 billion (exchequer and private matching
funds) to strengthening national research
capabilities via investment in human and physical
infrastructure.
• Over 5 cycles, PRTLI provided integrated financial
support for institutional strategies, programmes
and infrastructure
Molecular Medicine Ireland – a case
study
• 1999-2001
– UCD Conway Institute and TCD Institute for
Molecular Medicine funded as separate Institutes
• 2002
– UCD and TCD collaborated to create Dublin
Molecular Medicine Centre (DMMC)
• 2005
– RCSI joined DMMC
• 2008
– DMMC evolved into Molecular Medicine Ireland
(MMI) with UCC and NUIG joining as full partners
UCD Conway Institute
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11,500M2 biomedical science complex opened in 2003 housing 550
research, technical & administrative staff
94 Conway Fellows & their teams with 255 graduate students
Research Focus : Translational Sciences & Systems Biology
– Diabetes & vascular biology; infection, immunity & repair; neuroscience
•
Core technologies
– Bioinformatics, genomics, proteomics, transcriptomics, transgenics
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Funding
€92 million Capital
>€150 million Research Grants
•
Innovation Culture
Wyeth Research Labs
Discovery antibody technologies
Conway Institute for Biomedical & Biomolecular Research
TCD Core facilities
Centre for Biomedical Sciences
70,000 sq m facility, dedicated to the integration of the
research efforts of Medicine, Biochemistry and
Immunology, Chemistry and Pharmacy with a strong focus
on translational technologies involved in drug discovery
such as structural biology and medicinal
chemistry
Institute of Molecular Medicine
With core facilities in bio-banking, immunology, high level
genomics, functional genomic, proteomic and high content
screening capacity
Trinity Centre for Bioengineering
With a biomechanical testing laboratory, tissue
preparation laboratory, biomaterials laboratory, tissue
engineering laboratory and the impact biomechanics
laboratory
Molecular Medicine Ireland – a case
study
• 1999-2001
– UCD Conway Institute and TCD Institute for
Molecular Medicine funded as separate Institutes
• 2002
– UCD and TCD collaborated to create Dublin
Molecular Medicine Centre (DMMC)
• 2005
– RCSI joined DMMC
• 2008
– DMMC evolved into Molecular Medicine Ireland
(MMI) with UCC and NUIG joining as full partners
Collaboration
• UCD and TCD created the Dublin Molecular
Medicine Centre (DMMC) to provide critical
mass in Irish biomedical research.
– promote collaborative translational research and
cross-institution post-graduate education and
training curriculum.
• Enabled construction of infrastructure for
molecular medicine in Dublin providing core
facilities in genomics, proteomics, cell
biology and ‘cellomics’ within an integrated
architecture with citywide access,
• Commenced process of integrating clinical
research.
Molecular Medicine Ireland – a case
study
• 1999-2001
– UCD Conway Institute and TCD Institute for
Molecular Medicine funded as separate Institutes
• 2002
– UCD and TCD collaborated to create Dublin
Molecular Medicine Centre (DMMC)
• 2005
– RCSI joined DMMC
• 2008
– DMMC evolved into Molecular Medicine Ireland
(MMI) with UCC and NUIG joining as full partners
© DAMC 2009
Dublin Academic
Medical Centre
Dublin Centre for Clinical Research
• DMMC partners developed a joint application (led by
Dermot Kelleher at TCD) to Wellcome Trust to create
Dublin Center for Clinical Research
• PRTLI funded CRCs at UCD and RCSI
• Wellcome Trust funding new CRC and HRB funding
network activities
• Building on research strengths in infection & immunity,
neuropsychiatry, molecular therapeutics, cancer.
• Funding commenced in 2008 – over 2,000 patients recruited
to network studies
Dublin Centre for Clinical Research
Wellcome Trust – HRB Clinical Research
Centre at St. James’s Hospital
3 Tesla
MRI
Neurophysiology
Suite (EEG)
Exercise
Physiology
Lab
Six
Bed
Day
Unit
Four
Isolation
Rooms
Gene
Therapy
Pharmacy
Molecular Medicine Ireland – a case
study
• 1999-2001
– UCD Conway Institute and TCD Institute for Molecular
Medicine funded as separate Institutes
• 2002
– UCD and TCD collaborated to create Dublin Molecular
Medicine Centre (DMMC)
• 2005
– RCSI joined DMMC
• 2008
– DMMC evolved into Molecular Medicine Ireland (MMI)
with UCC and NUIG joining as full partners
Vision - improved healthcare through the
development of diagnostics and therapies from
concept to realisation
The mission of MMI is to mobilise the
strengths of the five partner
institutions and their associated
hospitals to build a sustainable
national system to coordinate,
support and promote translational
and clinical research
MMI Education & Training
Widely Available Short Courses & Workshops in Clinical and Translational Research
• Designed for a cross-institutional audience: 2942 attendances (20032009).
• Application and provision of course materials via MMI website.
Attendances Breakdown 2003-2009
MMI PhD Training Programmes in Clinical &
Translational Research
• From 2008, 22 medical graduates are undertaking
PhD studies in five academic institutions as MMI
Clinician Scientist Fellows with shared national
structured training (funded through PRTLI Cycle 4).
• The structured training curriculum will form a sustained
resource, available via the MMI website, for all medical
graduates undertaking PhD studies in the future. Over sixty
graduate education modules have been assembled to date
from MMI partner institutions.
• From 2011, 20 basic science graduates will undertake PhD
studies in clinical and translational research as MMI
Scholars with industry involvement in courses and
placements (funded through PRTLI Cycle 5).
For more information visit
www.molecularmedicineireland.ie
Information Technology Infrastructure
• Professional IT Manager
• IT function has a cross institutional
mandate
• IT Priority: IT that supports
multisite clinical research
activities:
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Study Management
eCRF
Sample tracking
Research Ethics
DCCR’s Clinical Research Networks
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Diabetes Group – John Nolan
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Respiratory Medicine Group – Michael Keane
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Latent TB Incidence, HIV and TB and TB immunity and Vitamin D (studies in planning)
Neurodegeneration – Orla Hardiman
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Continued investigation of potential biomarkers
Infectious Diseases (HIV/TB) – Paddy Mallon/Colm Bergin
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Extension of Wellcome Trust Case Control Consortium Study of patients with psychosis
Prostate Cancer Research Consortium – Mark Lawler
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WT and Children’s Research Foundation funding for international collection of 4000 samples from Children with Eczema to
start in 2010
Neuropsychiatry – Michael Gill
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Coeliac Disease DNA collection – ongoing – 200 + samples collected in 9 months
Barrett’s Oesophagus – Invited to participate in WT Case Control Consortium
Inflammatory Skin Disease – Alan Irvine
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IPF/Sarcoidosis – Bio – repository - 215+ patients recruited to date
Device for Asthma Patients – Going through ethics for six hospital sites
Gastroenterology Group – Ross McManus
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GUIDANCE Study (EASD) – completed with 946+ patients recruited by 17 Consultants
Registry for Young Onset Neurodegeneration
Ophthalmology – David Keegan
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Registry of Patients with Severe Retinal Dystrophy
DCCR - Excellence in Research
Coeliac Disease Genetics and
Immunology
Nature Genetics 2010, BMC Medical Genetics 2010
Neuropsychiatric Genetics
Nature Genetics 2009, NEJM 2008
Platelets & Coronary Artery Disease
J of Thrombosis and Haemostasis, 2008
Novel Bioactive Peptides
Nature Chem. Biol. 2007
Lung Cancer Diagnostics
Nature Medicine 2007
Cystic Fibrosis Pathogenesis
J Biol. Chem. 2007, 2008
Prostate Cancer
Prostate 2010, British Journal of Urology, 2010
DCCR - New Therapeutics Discovery fuelling the pipeline
Clinical Research activity undertaken
Vaccine for Helicobacter Pylori
Novartis Phase II Clinical Trial
Funded by?
OPN-501 New Drug for IBD
Resulting Publications?
Opsovax Cancer Vaccine
Opsona Clinical Development
Opsona Clinical Development
RNAi Therapeutics
Genable GT015
Dissociated APC
Pure anti-inflammatory properties
• Ireland a country of choice for scientifically relevant
multi-centre clinical studies and trials in specialist fields
where partners are strong.
Irish Clinical Research Infrastructure Network- ICRIN
Objectives
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Network MMI partner CRCs and research teams into a national
infrastructure
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Develop and deliver clinical research education/training programmes
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PIs, Research nurses, clinical research staff
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Facilitate academic and industry clinical investigators to conduct multicentre clinical studies/trials
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Drive harmonisation of clinical research procedures
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Research Governance, Informed Consent, Ethical Review, Data Monitoring
and Safety Reporting
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Research Readiness Programme
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As the Irish scientific partner, contribute to building the European Clinical
Research Infrastructure Network
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ICRIN Research Readiness
Quality Oversight
Research Governance, Sponsorship
Advisory and
Consulting
Quality Management (SOPs, Training)
Training/Education
ICRIN
Hub
Communication
and Promotion
Regulatory/Best Practice
Horizon Scanning
Trial Management and Oversight
CRC/CTU
Regulatory and Ethics
Administration and Logistics
Trial Design and Statistical
Methodology
IT solutions and Data Management
National and EU
Interface
Clinical/Hospital Governance
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Process Management
Dublin Academic
Medical Centre
© DAMC 2009
Irish public policy
• Centres of excellence in Health Care Delivery
• Centres of world significance in translational health
research
• Clear and transparent governance structures
between teaching hospitals and their associated
university
• Critical need to reduce expenditures and staff
numbers
• Leveraging Health for job creation
Children’s Health First (2006),
– Strategy for Cancer Control (2006),
– Report of the National Task Force on Medical Staffing (2003)
– Strategy for Science, Technology & Innovation 2006-2013
– Towards better health: achieving a step change in Health Research in Ireland, 2006
– Fottrell report on Medical Education, 2005
Report of the Special Group on Public Service Numbers and Expenditure Programmes (2009);
OECD Public Management Review – Ireland: Towards an Integrated Public Service 2009;
Building Ireland's Smart Economy: A Framework for Sustainable Economic Renewal, 2008
Dublin Academic
Medical Centre
© DAMC 2009
Investment - UCD
• Significant public investment
– UCD Conway Institute
– UCD Charles Institute
(Dermatology)
– UCD Geary Institute (economics)
– Systems Biology Ireland (SFI CSET)
– TRIL (Ageing, Intel)
– NIBRT
– UCD Clinical Research Centres at
MMUH and SVUH
Dublin Academic
Medical Centre
© DAMC 2009
Hospital relationship
• Two major teaching
hospitals
• Combined annual
budget 600 m euro
state funded but
independently managed
• majority of clinical staff
no deep loyalty to the
University
• Even Universityappointed clinical staff
have divided loyalties.
Dublin Academic
Medical Centre
Why an AMC - UCD issues
• UCD identified translational medicine as a
key strategic goal
– ‘UCD Conway Institute will be a global leader in
biomedical research and through partnership will
translate this knowledge to benefit patients’
• For university to be successful,
– need a cadre of clinical investigators
– need to be able to have a major input into their
appointment and into the allocation of their time.
– Need to establish research and education as key
missions and values in hospital
© DAMC 2009
Dublin Academic
Medical Centre
Dublin Academic Medical Centre
Ireland’s first patient-focused academic medical centre
incorporating Mater Misericordiae University Hospital, St.
Vincent’s Healthcare Group, and University College Dublin
Mater Misericordiae University Hospital
© DAMC 2009
St Vincent’s University Hospital
UCD Health Science Centre
Dublin Academic
Medical Centre
DAMC at a glance
• Merger creates largest hospital
group in Ireland
– Improved financial and
operational performance
• Patients, population and staff
– Currently > 400,000 patient
contacts a year
– Serving a local population of
750,000
– 5000 staff including 350
consultants
– National and regional specialty
services
• maintain and improve of
© DAMC 2009
excellent patient care with a
culture of research driven
quality
• Can expand to other hospitals
Dublin Academic
Medical Centre
How it works
• Single integrated leadership and
management throughout
– C hief Academic Officer key position
• Integrated strategic, operational
and capital planning
• Development of site specific
clinical services
• Joint appointments and
programmes
• Clinical services, research,
innovation and education
purposefully linked
© DAMC 2009
Education
Patient Care
Research and
Innovation
Dublin Academic
Medical Centre
Core Activities
• Patient care
– Integrated clinical care strategy
– Evidence-based
– Technology-enabled
• Digital health – UCD School of Computer Science and Informatics*
– Effectively and efficiently managed
• Education
– Undergraduate
• Medicine
• Other professions - Nursing, Physio, DI
– Postgraduate
– Healthcare management - UCD Business School*
– CPD
© DAMC 2009
Dublin Academic
Medical Centre
Core Activities
• Research
– Rigorous review and single research strategy
– Major categories
• Translational bench-to-bedside research
–
UCD Conway Institute
• Clinical trials and clinical investigation
–
Clinical Research Centre, Molecular Medicine Ireland
• Health systems, outcomes and economics
–
UCD Geary Institute
• Niche areas
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Biomedical engineering*
Dermatology (Charles)
Technology Research for Independent Living (Intel)*
– Site-specific differentiation
– Education/research magnet for recruitment tool
© DAMC 2009
Dublin Academic
Medical Centre
Core Activities
• Innovation and Enterprise
– NovaUCD
– DAMC as technology test bed
• Thought leadership
– DAMC-Geary Institute Partnership
• Children/poverty/health/human development
• Ageing/elder abuse/social change
– Evidence-based health policy
– Wider public engagement
© DAMC 2009
Dublin Academic
Medical Centre
Current challenge
• Just as we get the infrastructure in place to
potentially become internationally
competitive, bottom falls out of Irish
economy
• Core University funding cut by 20% and
likely to fall further
• Health care spending to be cut 20% in next
3 years
– Patient services will take priority over research
and education
• Research funding dropped dramatically –
75%
© DAMC 2009
Dublin Academic
Medical Centre
UCD/TCD Innovation Alliance
• National recovery initiative built around the
development of the Smart Economy
• UCD/TCD Joint Venture in Enterprise
Development
• UCD/TCD Innovation Academy
• Closer collaboration between Medical
Schools
– Dublin Centre for Rheumatologic Research
– Joint Centre for Vision Sciences
– Joint Dept of Paediatrics at new CHOI
© DAMC 2009
Dublin Academic
Medical Centre
Experience is what we call our mistakes.
Oscar Wilde
© DAMC 2009
Ireland – small island in global
world
• Collaboration essential
– Internal and external
• Identify strengths (and
weaknesses)
• Coherent strategic
vision – government
and organization
• Fortitude to execute the
vision
• Funding models
– Core
– Research
– People