Dr David Keegan - AGM 2011 - DCCR Overview

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


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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)


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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


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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


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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


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


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


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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


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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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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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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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The Team

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

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Next Phase

• Build numbers• Collate the various registers that

exist• Expand and include more

comprehensive information

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Regulation

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

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Therapy

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

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Any Questions

Dr David Keegan - AGM 2011 - DCCR Overview

Health & Medicine

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