DCCRDublin Centre for Clinical Research

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Wellcome Trust – HRB Dublin Centre for Clinical

Research

01 October 2011

By

David KeeganChair of Ophthalmology Division of

DCCR

DCCRDublin Centre for Clinical Research

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• In 2006 three Dublin Medical Schools (TCD, RCSI and UCD) responded to a Wellcome Trust call to fund clinical research infrastructure.

• Dublin application scored second and this resulted in €23M in funding from the Wellcome Trust and Health Research Board:– ~€10m the development of a Clinical Research Centre (CRC) at

St. James’s Hospital

– Five years operational funding (~€13m) for DCCR Network and St. James’s Hospital Clinical Research Facility

About the Dublin Centre for Clinical Research (DCCR)

DCCRDublin Centre for Clinical Research

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Transformation of clinical research in Dublin through development of physical, human resource and administrative infrastructure for safe, ethical and excellent patient-focused research

DCCR’s Vision

DCCRDublin Centre for Clinical Research

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Components of Vision

• Excellence in research• Up-skilling and enlargement of research nursing and

clinician scientist pool• Provision of a clinical research IT Infrastructure• Streamlining inter-institutional research protocols• Integration of research programmes with clinical

research infrastructure• Completion of Dublin’s clinical research facility

infrastructure with the construction of a CRC at St. James’s Hospital

DCCRDublin Centre for Clinical Research

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DCCRDublin Centre for Clinical Research

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Research Nursing Development:• Recruitment of Network Research

Nurses – 8 Network Nurses Now in Place

• Common GCP Training – 4 courses in 2009 and 5 courses in 2010

• Certificate Course in Research Nursing – 12 candidates 2009- 10 candidates 2010

• Revival of Irish Research Nurses Network

• Further post graduate education for nurses and other clinical research

DCCR’s Research Network Infrastructure

DCCRDublin Centre for Clinical Research

Information Technology Infrastructure

• Professional IT Manager (John McCourt) started in April 2009

• IT function has a cross institutional mandate

• IT Priority: IT that supports multisite clinical research activities:

• Study Management

• eCRF

• Sample tracking

• Research Ethics

DCCRDublin Centre for Clinical Research

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Wellcome Trust – HRB Clinical Research Facility at St. James’s Hospital

DCCRDublin Centre for Clinical Research

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Wellcome Trust – HRB Clinical Research Centre at St. James’s Hospital

Neurophysiology Suite (EEG)

CAMI 3T MRI

Exercise Physiology

Lab

Six Bed Unit

Four Isolation Rooms

Gene Therapy

Pharmacy

DCCRDublin Centre for Clinical Research

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• Ophthalmology – David Keegan• Registry of Patients with Severe Retinal Dystrophy

• Diabetes Group – John Nolan– GUIDANCE Study (EASD) – completed with 946+ patients recruited by 17 Consultants

• Respiratory Medicine Group – Michael Keane• IPF/Sarcoidosis – Bio – repository - 215+ patients recruited to date

• Device for Asthma Patients – Going through ethics for six hospital sites

• Gastroenterology Group – Ross McManus• 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• WT and Children’s Research Foundation funding for international collection of 4000 samples from

Children with Eczema to start in 2010

• Neuropsychiatry – Michael Gill• Extension of Wellcome Trust Case Control Consortium Study of patients with psychosis

• Prostate Cancer Research Consortium – Mark Lawler• Continued investigation of potential biomarkers

• Infectious Diseases (HIV/TB) – Paddy Mallon/Colm Bergin• Latent TB Incidence, HIV and TB and TB immunity and Vitamin D (studies in planning)

• Neurodegeneration – Hardiman• Registry for Young Onset Neurodegeneration

DCCR’s Clinical Research Networks

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DCCRDublin Centre for Clinical Research

Ophthalmology and the DCCR

• An important part of DCCR strategy• To integrate existing registers while

designing new items• To develop the regulatory strategy• Successful gene therapy trials in

eye disease• Develop more novel treatments 1

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DCCRDublin Centre for Clinical Research

Progress to Date

• Commenced process for ethical approval for specific registers to identify patients with inherited retinal disease

• Modular fashion• Ethical approval and CRF

developed• First three clinics have taken place

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DCCRDublin Centre for Clinical Research

The Team

• Jeremy Townes• John McCourt• Marie Burke• Paul Kenna• Jane Farrar• Andrew Greene• Avril Daly• Anna Moran 1

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DCCRDublin Centre for Clinical Research

Next Phase

• Build numbers• Collate the various registers that

exist• Expand and include more

comprehensive information

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DCCRDublin Centre for Clinical Research

Regulation

• Experience of other groups• Major stumbling black• There for a reason• Safety • Pathway to therapy

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DCCRDublin Centre for Clinical Research

Therapy

• Gene Therapy• Neuro-protectants• Retinal implants• Stem cells

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DCCRDublin Centre for Clinical Research

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Any Questions