roc ipposi dec2015 challenges and opportunities for clinical research
TRANSCRIPT
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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
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Irish Clinical Research
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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
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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!!
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My relevance/bias?
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History of clinical researchKing Nebuchadnezzar II King of Babylon 605-562 BCThe book of Daniel
Wine and MeatVs.Vegetables & water
Dr. James Lind 1747Naval doctor
Scurvy treatment 12 patients total, 6 groups of 2Citrus vs. other acids/ seawater
First Declaration of Helsinki - 1964
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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.
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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!
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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
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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
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How are we doing in Ireland?
Irish Researchers • a long and proud tradition of impactful clinical
researchDr 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
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But the goal post are changing dramatically!• Regulatory issues• Cost• Collaboration • Applied and prioritised research -development of a
“product”• Internationalisation
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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
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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
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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
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Clinical Trial Activity 2011 and 2014
*Including only open studies, excluding studies with unknown statusData Source: Clinicaltrials.Gov
Slides courtesy of Dr. Fionnuala Keane, COO, HRB- CRCI
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Things may be getting better!
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Recognition of the “problem”
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Gap AnalysisNumbe
r: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 studies5 Difficulties with research nurse resourcing and retention6 Lack of integration of the CRF/Cs and networks with
healthcare system 7 Poor support for research staff within the health service8 No single central point of access for clinical research9 Poor visibility of clinical research information10 Lack of business development on a national scale
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Patients
• Better patient involvement and education
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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
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Strengthening research networks
Examples• IRNN• ICORG• MMI• HRB TMRN
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Geographical Location of CRF/C’s
Applicant CRF/CNon-Applicant CRF/C
23
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Regulatory
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Ongoing issues 1/2
• State & Industry investment in Health research• Data rights of individual vs community
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Ongoing issues 2/2
• Workforce support – Researchers, data managers, research nurses– Researcher careers
• Skills shortages -epidemiology, statistics, researcher loss/emigration (rental)
• Communications
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Summary 1/2
Clinical research is • Vital to driving health improvement– Medically– Scientifically – Organisationally– Economically
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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