HRB Clinical Research Coordination Ireland

1. Dr Fionnuala Keane
Chief Operating Officer
Oct 14th 2015

2. HRB Clinical Research Coordination Ireland
• A national integrated clinical research network of
the Clinical Research Facilities/Centres (CRF/C) in
Ireland
• Co-Funded
• Health Research Board
• Enterprise Ireland
• 5 Universities - MMI
• 1 May 2015
2

3. Geographical Location of CRF/C’s
Applicant
CRF/C
Non-Applicant
CRF/C
3

4. Clinical Trial Activity 2011 and 2014
*Including only open studies, excluding studies with unknown status
Data Source: Clinicaltrials.Gov
4

5. Gap Analysis
5
Number: Gap Detail:
1 Difficulties in investigator and site identification
2 Delayed study start-up timelines
3 Inadequate patient identification and recruitment
4 No central provision of study sponsorship for academic/investigator
led studies
5 Difficulties with research nurse resourcing and retention
6 Lack of integration of the CRF/Cs and networks with healthcare system
7 Poor support for research staff within the health service
8 No single central point of access for clinical research
9 Poor visibility of clinical research information
10 Lack of business development on a national scale

6. Gap Analysis
6
Number: Gap Detail:
1 Difficulties in investigator and site identification
2 Delayed study start-up timelines
3 Inadequate patient identification and recruitment
4 No central provision of study sponsorship for academic/investigator
led studies
5 Difficulties with research nurse resourcing and retention
6 Lack of integration of the CRF/Cs and networks with healthcare system
7 Poor support for research staff within the health service
8 No single central point of access for clinical research
9 Poor visibility of clinical research information
10 Lack of business development on a national scale

7. Gap Analysis
7
Number: Gap Detail:
1 Difficulties in investigator and site identification
2 Delayed study start-up timelines
3 Inadequate patient identification and recruitment
4 No central provision of study sponsorship for
academic/investigator led studies
5 Difficulties with research nurse resourcing and retention
6 Lack of integration of the CRF/Cs and networks with healthcare
system
7 Poor support for research staff within the health service
8 No single central point of access for clinical research
9 Poor visibility of clinical research information
10 Lack of business development on a national scale

8. Gap Analysis
8
Number: Gap Detail:
1 Difficulties in investigator and site identification
2 Delayed study start-up timelines
3 Inadequate patient identification and recruitment
4 No central provision of study sponsorship for academic/investigator
led studies
5 Difficulties with research nurse resourcing and retention
6 Lack of integration of the CRF/Cs and networks with healthcare system
7 Poor support for research staff within the health service
8 No single central point of access for clinical research
9 Poor visibility of clinical research information
10 Lack of business development on a national scale

9. Scottish Services:
- NHS Research Scotland - NRS
- Industry Liaison and Permissions
teams
- central support and liaison office
- One price for Scotland
- One contract for Scotland
- Population– 5.2 million
Northern Ireland Services:
- The Northern Ireland Clinical
Research Network – NICRN
- central support and
liaison office
- The Northern Ireland Clinical
Trials Unit – NICTU
- Trial related services
Danish Service:
- Danish Clinical Research
Infrastructures Network
– DCRIN
- central support and
liaison office
- Danish Clinical Research
Consortium – DCRC
- virtual consortium
French Services:
- The French Clinical
Research Infrastructure
Network - F-CRIN
- central support and
liaison office
- established in 2012
- self sustaining by 2019
UK Services:
- The National Institute for Health
Research Clinical Research Network –
NIHR CRN
- central support and liaison office
- The NIHR Office for Clinical Research
Infrastructure - NOCRI
Review of services elsewhere
9

10. Aims of HRB CRCI
• To provide the skills, expertise and infrastructure to
design, conduct and analyse multi-centre clinical trials
involving human participants in Ireland
• To support both academic and industry initiated clinical
trials involving pharmaceuticals, neutraceuticals or
clinical care pathways as well as clinical investigation of
medical devices
• To enhance Ireland’s capacity for conducting innovative
high quality clinical research for the benefit of people’s
health and the economy
• To advance the care of patients by enabling a connected
and coordinated Clinical Trial Network
10

11. Delivery on Aims of HRB CRCI
HRB CRCI aims to:
• Act as a central point of contact for academia
and industry alike
• Be an efficient, knowledgeable and accurate
signposting service
• Provide an improved feasibility process for
Ireland
• Improve study start-up timelines for Ireland
• Develop a coordinated Quality and Training
working group
11

12. Proposed Role of HRB CRCI
Based on UK Model of support - NOCRI, NIHR
CRN, NHS Research Scotland
1. Primary/Central point of contact and access
to the Network for industry and academics -
Pharma and Devices etc.
2. Study Feasibility process support
• Investigator and site identification
• Potential recruitment and patient
portfolio information
3. Study start-up support – timely delivery
4. Contract and Indemnity advice
5. Recruitment reports – timeline delivery
12

13. Proposed Role of HRB CRCI (ctd)
6. Regulatory and ethics process advice
7. Monitoring and Auditing services
8. Training and education – quality control and
standardisation
9. Promoting/Presenting/Advertising Ireland as a high
quality location for clinical research
10. On-line services - Template documents – costing
tools; study concept template; standard
contracts…study documents in general www.hrb-
crci.ie
13

14. HRB CRCI Areas of Impact and Influence
Number: Gap Detail:
1 Difficulties in investigator and site identification
2 Delayed study start-up timelines
3 Inadequate patient identification and recruitment
4 No central provision of study sponsorship for academic/investigator
led studies
5 Difficulties with research nurse resourcing and retention
6 Lack of integration of the CRF/Cs and networks with healthcare system
7 Poor support for research staff within the health service
8 No single central point of access for clinical research
9 Poor visibility of clinical research information
10 Lack of business development on a national scale
Influence
14
Impact

15. HRB CRCI Structure
HRB CRCI
CRF/C
based staff
HRB CRCI
Central Office
HRB CRCI
Senior
Management
Team
CRCI Chair
(CRF/C
Director)
15

16. Areas of Development for HRB CRCI
• General Operations
• Scale up staff numbers in the central office and at the
CRF/C’s
• Support implementation of Data systems – study data
management and activities management systems
• Inclusion of CRF Limerick, Crumlin, (Belfast)
• Centralised specialised services
• Development of a national pharmacovigilance service
for academic studies
• Provision of a national biostatistics service
16

17. Areas of Development for HRB CRCI
• Health Economics Evaluation provision
• Initial evaluation to quantify the benefits of clinical
research to the Health System and to the Economy
• Central position in CRCI – providing ongoing Health
Economic advice e.g. teaching; grant application
support
17

18. Areas of Development for HRB CRCI
Operational resources required for upscale activities
• Nurses in the CRF/C’s
• Central office staff
• Additional Monitors and Auditors
• Programme/Project Leads
• Pharmacovigilance service
• Health Economics Evaluation Specialist
• Data Management systems
• Study specific data management
• Activities management systems
18

19. Industry and HRB CRCI – Initial Support
1. Work with HRB CRCI to build portfolio of
clinical trial activity for Ireland
• Focus HRB CRCI activities on disease areas of
interest to industry
• Discuss/promote HRB CRCI and it’s services at
European and Global level
• Work with HRB CRCI on delivery of it’s
feasibility service – test/build the system by
channelling studies via HRB CRCI
19

20. Industry and HRB CRCI – Initial Support
2. Collaborate with HRB CRCI on the
development and delivery of standard
systems and template documentation
• Standard Confidentiality Agreements
• Standard Costing Template
• Standard Contract Template
20

21. Challenges to conducting research
within the HSE
1. Hospitals working with the CRF/C’s
The CRF/C have the necessary expertise and staff to conduct
trials but are primarily based in the university or the primary
university hospital
– Develop formal research agreements between hospital
groups and university CRF/Cs
2. Hospital approval process for Clinical trials
Approval of research contract/indemnity provisions at group
rather than hospital level, with hospital approval of SSA form
regarding hospital resource utilization
3. Research Ethics Committee Approval for low risk
observational research
Cross-recognition of hospital RECs within Groups for low risk
observational research 21

22. Challenges to conducting research
within the HSE
4. Embedding research within the healthcare system
Dedicated research space embedded within clinical
outpatient spaces
5. Support of Research Staff within the HSE
Back-fill for clinicians seconded part-time on
research
22

23. Thank you!
Dr Fionnuala Keane
HRB CRCI Chief Operations Officer
E: Fionnuala.keane@hrb-crci.ie
T: 01 4779819 Mob: 086 1740103