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Roc ipposi dec2015 challenges and opportunities for clinical research
1. Dr. Robert O’Connor Head of Research, Irish Cancer Society
@drrobertoconnor
www.cancer.ie/research/
Challenges & opportunities for clinical
research in Ireland
@irishcancersoc
https://www.youtube.com/user
/IrishCancerSociety/playlists
2.
3. A little bit about us…
• Ireland’s largest Charitable funder of research
• Annually we spend ~ €3m just on research
hard-earned charity money (not govt money!)
to internationally competitive Irish researchers
Cancer Research UK & Macmillan
– annual spend ~€900m
4. What is the Irish Cancer Society
RESEARCH role?
• Provide the best research for Irish Cancer patients
• Support cancer research community to serve Irish
patients
Through research,
– ensure that Irish patients have least risk of getting cancer,
– best treatment if they do
– most HOPE of thriving afterwards.
– Make sure they know about it too!!
6. History of clinical research
King Nebuchadnezzar II King of Babylon 605-562 BC
The book of Daniel
Wine and Meat
Vs.
Vegetables & water
Dr. James Lind 1747
Naval doctor
Scurvy treatment 12 patients total, 6 groups of 2
Citrus vs. other acids/ seawater
First Declaration of Helsinki - 1964
7. What is clinical research?
Research undertaken on a person/group or material directly
from them
• Conducted in an organised/planned way
• Might look at
– Disease
– Behaviour
– Response
– Cause
– Outcome
– Perspective
– Efficiency
– Economics
– Prospectively/retrospectively
• To identify positive, negative or neutral factors in
health, behaviour, disease etc.
8. Why do we do clinical (patient) research?
• Evidence for understanding illness & improving
an outcome and efficiency
– New Pharmaceuticals/medicines/drugs
– Diagnostics/Biomarkers
– Organisation/management/delivery
– Defining problem/challenge
– Economics
– Answering a question
– Commercial value
• All science models have limitations!
9. The “players” in Ireland
• Academic institutions (universities/colleges/hospitals)
– Researchers and Ethics in each
• State agencies (inc. regulators)
– DOH, DJEI
• Charity sector
• Patients & representative groups
• Industry
– Pharma (production, corporate, medicines provision),
medical devices, market research companies
• Infrastructure
– ICORG, HRB-CRCI
10. What drives impactful clinical research?
• Educated public
• Outcome-driven vision of health
• Motivated researchers/workforce
• Trained researchers/workforce
• Networked researchers & Infrastructure
• A regulated but supportive environment
• Industry and finance
• Heath system integrated with academia
• Researchers who communicate with public
11. How are we doing in Ireland?
Irish Researchers
• a long and proud tradition of impactful clinical
research
Dr Mary Patricia "Moya" Cole - Tamoxifen
Dr Denis Parsons Burkitt - Lymphoma
Prof. Gerry McElvaney – lung disease
Prof. Luke Clancy
– tobacco control
Dr Vincent Barry- Leprosy treatment
12. But the goal post are changing dramatically!
• Regulatory issues
• Cost
• Collaboration
• Applied and prioritised research -development of
a “product”
• Internationalisation
13. Some current challenges 1/3
• Lack of public support
– Education
– Researchers not communicating research value
– Patient exclusion
– Poor participation
• Paediatric cancer trials 70% (of 200)
• Adult cancers 3% (of 20,000)
• State agencies
– Underinvestment
– Economic depression
– Lack of strategy
– Complexity
– Lack of understanding
– Policy focus on production Vs. research
14. Challenges 2/3
• Infrastructure
– Physical and organisational
– Lack of permanent research structures
– Limited career structure
– Workforce models /training
• Low aspirations of some researchers
– Publication vs enactment of findings
• Globalisation/competition
– Esp. for clinical research of commercial value
15. Challenges 3/3
• Regulatory
– Increased complexity
– Lack of single ethics (83 ethics committees)
– Underresourcing of ethics committees
– Data privacy regulation
• Research focus
– Focus of information gathering vs. evidence-based action
– Portfolio imbalance
• Prevention, early detection, survival vs. treatment
• Exercise, behaviour modification vs. treatment
16. Clinical Trial Activity 2011 and 2014
*Including only open studies, excluding studies with unknown status
Data Source: Clinicaltrials.Gov
Slides courtesy of
Dr. Fionnuala Keane,
COO, HRB- CRCI
19. Gap Analysis
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
21. State agencies
• New head of R&D in Dept of Health
• New Chief Information Officer in HSE
• Cancer Strategy calling out research
• New DEJI research strategy
• State analysis of/investment in infrastructure
– ICORG
– HRB-CRCI
25. Ongoing issues 1/2
• State & Industry investment in Health
research
• Data rights of individual vs community
26. Ongoing issues 2/2
• Workforce support
– Researchers, data managers, research nurses
– Researcher careers
• Skills shortages -epidemiology, statistics,
researcher loss/emigration (rental)
• Communications
27. Summary 1/2
Clinical research is
• Vital to driving health improvement
– Medically
– Scientifically
– Organisationally
– Economically
28. Summary 2/2
• Ireland has a significant history of impactful
achievement in Clinical Research
• Has a vibrant and productive research
community- punching above its weight
• Recognises opportunities & ready to capitalise
on improvements
Editor's Notes
What is the role/function of the research dept with in the Society?