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

Irish Clinical Research

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

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!!

My relevance/bias?

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

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.

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!

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

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

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

But the goal post are changing dramatically!• Regulatory issues• Cost• Collaboration • Applied and prioritised research -development of a

“product”• Internationalisation

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

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

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

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

Things may be getting better!

Recognition of the “problem”

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

Patients

• Better patient involvement and education

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

Strengthening research networks

Examples• IRNN• ICORG• MMI• HRB TMRN

Geographical Location of CRF/C’s

Applicant CRF/CNon-Applicant CRF/C

23

Regulatory

Ongoing issues 1/2

• State & Industry investment in Health research• Data rights of individual vs community

Ongoing issues 2/2

• Workforce support – Researchers, data managers, research nurses– Researcher careers

• Skills shortages -epidemiology, statistics, researcher loss/emigration (rental)

• Communications

Summary 1/2

Clinical research is • Vital to driving health improvement– Medically– Scientifically – Organisationally– Economically

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