HRB Clinical Research Coordination Ireland Overview 2016

2. HRB Clinical Research Coordination Ireland
• A national integrated clinical research network of the Clinical Research
Facilities/Centres (CRF/C) in Ireland
• Providing overarching support and coordination of multicentre clinical
research activities
• Co-Funded
• Health Research Board,
• Enterprise Ireland
• 5 Universities – Molecular Medicine Ireland
• 1 May 2015

3. HRB Clinical Research Coordination Ireland
Collaborating CRF/Cs:
 HRI CRSU Limerick
 NICRF Belfast City Hospital
 NCRC Our Lady’s Children’s Hospital, Crumlin

6. 49
No. of combined
years performing
CT in the CRF/C
6
No. of CRF/C’s
(119) 134
No. of Staff
directly
employed by the
6 centres
(13) 14
No. of hospitals participating
in research studies through
the CRF/C’s
(216) 253
No. of Clinical Investigators
affiliated with the 6 CRF/C
(143) 174
No. of clinical trial study
sites open in (2014) 2015
across the 6 centres
Excluding
Observational, lab and
sample studies
Centre Metrics (Nov 2015) Apr 2016

7. Clinical trials ongoing in
26 Therapeutic Areas
1. Renal
2. Rheumatology/Musculoskeletal
3. Respiratory
4. Cardiology
5. Vascular disease
6. Neurology
7. Dermatology
8. Gynaecology
9. Endocrine
10. Neonatal
11. Urology
12. Stroke
13. Psychiatry
14. Ophthalmology
15. Oral and Gastroenterology
16. Hepatology
17. Haematology
18. Oncology
19. Critical Care
20. Infectious Disease
21. Metabolism
22. Geriatric
23. Anaesthesia
24. Physiotherapy
25. Occupational therapy
26. ENT

8. Clinical Research Facilities and Centres
Meeting unmet needs in Clinical Research in Ireland:
• Facilitating inter-department and inter-institutional Research
• Talking the lead on high impact research
• Delivering central coordination and management of
international academic projects
• Facilitating access to early interventions for Irish patients
• Providing necessary training programmes
• Answering important non-commercial research questions

9. Welcome Trust-HRB Clinical Research Facility at St James’s Hospital
SJHCRF supporting
a HRB Fellow
Gut Hormone Suppression increases food intake after
esophagectomy with gastric conduit reconstruction
Elliott JA et al, Ann Surg 2015
A novel therapeutic strategy to address major clinical challenge
of impaired nutritional status and HR-QL after oesophagectomy with
potential for immediate clinical application

10. Impact Research at HRB-CRF Galway
Health Services Research
Population Health
International Collaborations
Phase III RCTs
COMPASS Trial
(PHRI/Bayer: 22 Sites Ireland/UK; N=923)
HARP-2 Trial
(HRB-CRFG + CRFC-Belfast)
Early Phase Clinical Trials
Medical Device (e.g. CURAM)
Stem Cell Therapies

11. CFMatters – EU Consortium (FP7)
• EU Funding CFMATTERS is the first randomized, controlled trial comparing the use of microbiome-directed
antibiotic treatment versus standard therapy for patients with CF experiencing respiratory infections.
• EU Contribution: 5,999,748€
• Strategic Goals:
– Tailored prescribing to meet individual needs of Patients with CF
– Improved use of antibacterials
• CF Matters Trial
– Randomised, Multicentre, Controlled Trial
– Principal Investigator: Prof. Barry Plant, UCC & CUH
– 12 Partners, 6 Clinical Sites
– Current Recruitment: 102 patients (of 250 planned)
• CRF-C Supports to CF Matters
– International Trial Coordinating Centre
“…I was impressed about the professional clinical trial
management structures you have set up for the project …..”
Dr. Patricia Paukovits , FP7 Scientific Officer; CF MATTERS
• CRF-C also supports conduct of 5 other Academic international Trials funded by: HRB (RESUS AMI); FP7
(HIP. THRUST, NILVAD, OPERAM ); WT (ANSWER) and it has just received H2020 funding approval for
PREPARE (Preventing respiratory Events through proactive Assessment of Respiratory Effort) CFMatters is a medium-scale collaborative
project that has received funding from the
European Commission Seventh Framework
Programme, Grant Agreement no 603038

12. RCSI Clinical Research Centre
The ESCAPE study
The Malaria Vaccine Study
• Postgraduate Certificate in Nursing
(Clinical Research) Accredited by An
Bord Altranais and NUI

13. UCD School of Medicine
Scoil an Leighis
Current Study Portfolio
• Industry Clinical Trial = 50
• Investigator Clinical Trial = 14
• Translational = 38
• 2 Clinical Trial Networks
• SFI-Abbvie Dermatology
UCD Clinical Research Centre
-5
0
5
10
15
20
25
30
0.8 1 1.2
Rheumatology
Infectious Diseases
Endocrinology
Gastroenterology
Anaesthesia
Neurology
Opthalmology
Urology
Metabolic Diseases
“The CRC is a very well run and
organised unit. All staff are well
trained in Clinical research and
extremely committed to
producing work of the highest
quality. This unit is always
professional in its dealing with
Clinical Research Monitors and
it is a pleasure to work with
them”.
PPD CRA
• First IMB audited
Academic facility
• Sponsor of 12 Investigator
Initiated Clinical Trials
• Quality Management
System
• Staff training and
development
• Recognised internationally
• Clinical Scientist Awards
• Clinical Trial Networks

14. Vision for HRB CRCI
“That Ireland is internationally recognised for
conducting innovative high quality clinical
research for the benefit of people’s health and
the economy.”

15. Delivery on Aims of HRB CRCI
Based on UK Model of support - NHS Research Scotland, NOCRI,
NIHR CRN
HRB CRCI :
• Acting as a central point of contact for academia and industry alike
• Providing an efficient, knowledgeable and accurate signposting service
• Delivering an improved study feasibility process for Ireland
• Improving study start-up timelines for Ireland
• Developing a coordinated Quality Working Group

16. HRB CRCI Services and Activities
1. Signposting - efficient knowledgeable and accurate
2. Study feasibility - streamlined process
3. Study start-up – timely delivery
4. Recruitment tracking - collation of metrics
5. Promotion – ambassadors for Irish clinical research and
innovation
6. Advisory/Consultancy – regulatory pathways
7. Regulatory and Ethics – application process
8. Audit and Monitoring - oversight of study conduct
9. Quality working group - harmonisation
10. On-line services – www.hrb-crci.ie
Key supports
for Academic
Clinical Trials
Based on UK Model of support and in response to Irish clinical
research gap analysis

17. Quality and Regulatory Affairs
• QRAM: primary responsibility for quality elements of CRCI aims
• CRCI services managed via an integrated Quality Management
System with defined quality objectives, based upon international
standards and best practice
• Initial activities
- Quality/Regulatory support
- Audit service
- National Quality Working Group

18. Study Feasibility Programme
• Stream line Investigator site identification and study feasibility
process nationally
• Ensure consistency and efficiency, utilising the CRF/C network, to
significantly reduce the time taken to identify Investigators sites
and to assess study feasibility
• Process actively managed by CTLO with an aim to feedback within 2
weeks
1. Managing confidential information
2. Handling study feasibility request
3. Identifying potential investigators
4. Disseminating study feasibility
5. Completing study feasibility
6. Collating responses and informing applicant
7. Informing investigators of feasibility outcome

19. HRB CRCI National Study Feasibility Programme
HRB CRCI identifies potential Investigators
and disseminate study feasibility
Feasibility service
request received
HRB CRCI collate
feedback to applicant
Process actively managed with an aim to feedback within 2 weeks
Clinical Trial Network
Via the
CTN Lead
Clinical Research Facilities/Centres
Via dedicated HRB CRCI
CRF/C Research Nurse
Directly to Investigator
Via HRB CRCI
CTLO
Specialist Investigators

20. Flow Diagram proposed two–tier CDA
Process:
This revised model is a system wide change nationally so will take time to
implement.
In the interim
HRB CRCI and CRF/C site staff will support the standard model and aid the efficient
return of the study specific Sponsor–Investigator CDAs.
Tier 1: HRB CRCI put umbrella
CDA’s in place with each study
sponsor (or CRO) for current and
future clinical trials
Tier 2: HRB CRCI put umbrella
CDA in place with each hospital
groups, enabling HRB CRCI to
transmit confidential information
between it and employees within
the hospital group
38

21. Study Feasibility Overview
Type of requests:
CTLO has responded to 31 requests since appointment Aug 15
6 Country Review by KOL (i.e. collect Country Expression of Interest)
15 Investigator Identification & Feasibility Assessments (i.e. collect detailed feasibility
assessments)
8 Investigator Site Identification (i.e. collect Investigator Expression of Interest)
2 Referrals to Clinical Research Networks (e.g. ICORG)
11 Master CDA’s in place with Pharma companies and CRO’s
Average 12 calendar day turn around
27

22. Study Feasibility Overview
• Responded to 31 requests since Aug 15
• Engaged with >109 Investigators
• EOIs submitted for 23 out of the 31 studies
• 70 Investigator EOIs submitted
Status of 31 studies:
4 No EOI Submitted
2 Referred to CRN
2 Studies proceeding in Ireland
4 Studies not proceeding in Ireland
2 Studies on hold
11 Outcome pending
6 Ongoing feasibility assessments

23. HRB CRCI
Feasibility Point of Contact:
1. Anna Shevlin, Clinical Trial Liaison Officer, HRB CRCI
Email: Anna.shevlin@hrb-crci.ie Tel: +35314779815
2. Feasibility@hrb-crci.ie
3. Dr Fionnuala Keane, Chief Operating Officer, HRB CRCI
Email: Fionnuala.keane@hrb-crci.ie Tel: +353 1 4779819

24. Website: www.hrb-crci.ie
Launch 17-Feb-2016

25. Thank you
www.hrb-crci.ie
@HRB_CRCI