Proceedings of the Workshop on Hospital Approval of Clinical Trials ...

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<strong>Proceedings</strong>: MMI/ICRIN <strong>Workshop</strong> on Hospital Approval <strong>of</strong>
Clinical Trials, Newman House, 26 January 2012
Welcome and Introduction to <strong>the</strong> <strong>Workshop</strong>
Ruth Barrington, Molecular Medicine Ireland
Dr Ruth Barrington, CEO, <strong>of</strong> Molecular Medicine Ireland, welcomed over 70 participants from
hospitals, universities, patient organisations, disease networks, <strong>the</strong> pharmaceutical industry,
insurance and indemnity schemes and funding and regulatory bodies and said how pleased MMI
was with <strong>the</strong> level <strong>of</strong> interest in <strong>the</strong> issues to be addressed at <strong>the</strong> <strong>Workshop</strong>. She outlined <strong>the</strong>
background and objectives <strong>of</strong> <strong>the</strong> meeting (see Appendix 1) and linked <strong>the</strong>m to MMI’s mission to
enable clinical and translational research.
Ruth referred to ICRIN’s work, funded by <strong>the</strong> Health Research Board (HRB), in examining <strong>the</strong>
process by which hospitals approve <strong>the</strong> conduct <strong>of</strong> clinical trials involving <strong>the</strong>ir staff and patients
following ethical approval. The aim <strong>of</strong> this initiative is to explore <strong>the</strong> possibility <strong>of</strong> simplifying and
harmonising procedures for approval <strong>of</strong> multi-centre studies. In <strong>the</strong> course <strong>of</strong> this work, it quickly
became apparent that <strong>the</strong>re are differences in <strong>the</strong> manner hospitals approach <strong>the</strong> process <strong>of</strong>
approval and that <strong>the</strong>re are opportunities to streamline it. Ruth explained that <strong>the</strong> participants’
packs contained copies <strong>of</strong> <strong>the</strong> key documents involved in hospital approval <strong>of</strong> clinical trials.
Ruth went on to say that MMI had organised <strong>the</strong> workshop to clarify some <strong>of</strong> <strong>the</strong> issues that
present challenges for hospitals and also to assess <strong>the</strong> interest and motivation in moving towards a
harmonised approach to <strong>the</strong> approval <strong>of</strong> multi-centre studies in Ireland. The workshop provided an
opportunity for those directly involved in assessing clinical trial applications in hospitals to engage
with colleagues and principal investigators (PIs) from o<strong>the</strong>r hospitals, experts in medical indemnity
and insurance and <strong>the</strong> pharmaceutical industry to review issues that arise in hospital approval, to
share <strong>the</strong>ir experiences with each o<strong>the</strong>r and to explore <strong>the</strong> challenges <strong>of</strong> developing a harmonised
approach to <strong>the</strong> approval <strong>of</strong> multi-centre trials. Ruth concluded by introducing Ciaran Breen,
Director <strong>of</strong> <strong>the</strong> State Claims Agency, who chaired <strong>the</strong> first session.
Dr Ruth Barrington, Molecular Medicine Ireland

Approval <strong>of</strong> Clinical Trials- Hospital and Industry Perspectives
Chair: Ciaran Breen, State Claims Agency
Ciaran Breen opened <strong>the</strong> first session by referring to <strong>the</strong> role <strong>of</strong> <strong>the</strong> State Claims Agency in
medical research and <strong>the</strong> purpose <strong>of</strong> <strong>the</strong> clinical indemnity scheme (CIS). He said that <strong>the</strong> Agency
endorsed <strong>the</strong> importance <strong>of</strong> clinical research. “It is not our job to block or frustrate research; we see
ourselves playing a complementary role in <strong>the</strong> research process”, he said.
Ciaran Breen, State Claims Agency
Ms Muireann O’Briain, St James’s Hospital – What a hospital needs to know about a
clinical trial
Ms Muireann O’ Briain described how St James’s Hospital in 1997 decided to introduce a formal
process to review health research proposals and developed a number <strong>of</strong> procedures and forms
specific to <strong>the</strong> hospital for that purpose. In 2005, <strong>the</strong> hospital board recognised <strong>the</strong> opportunities for
establishing a strong research function, but did not pursue <strong>the</strong> possibilities with a corporate
strategy. As a result, research in <strong>the</strong> hospital is driven by individual clinicians.
On <strong>the</strong> positive side, Muireann mentioned that <strong>the</strong>re is a system in place in St James’s Hospital for
<strong>the</strong> ethical oversight <strong>of</strong> research, common indemnity and knowledge by <strong>the</strong> hospital <strong>of</strong> <strong>the</strong> research
it undertakes. The Health Service Executive (HSE) Standard Form <strong>of</strong> Indemnity has streamlined
dealings with pharmaceutical companies. There is also a growing interest in research, and
recognition <strong>of</strong> its use not only for clinical matters but also for audit and management purposes.
However, Muireann regretted that <strong>the</strong>re is no administrative support to assist PIs in writing
research proposals or negotiating contracts, no corporate administrative oversight <strong>of</strong> research
activity, no corporate oversight <strong>of</strong> <strong>the</strong> application <strong>of</strong> research funds, and no corporate mechanism
whereby completed research is reported back to management and evaluated. Ano<strong>the</strong>r concern is
<strong>the</strong> lack <strong>of</strong> a standard dispute resolution mechanism in clinical trial agreements.
Muireann said that she would welcome fur<strong>the</strong>r harmonisation for hospital approval <strong>of</strong> multi-centre
studies and concluded by pointing out that <strong>the</strong> range <strong>of</strong> research activities is expanding with <strong>the</strong>
emphasis now not only on <strong>the</strong> trialling <strong>of</strong> new drugs and combinations, but also on <strong>the</strong>
development <strong>of</strong> tools and strategies in health sciences. These opportunities should be grasped and
supported.
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Muireann O’ Briain, St James’s Hospital
Dr Rebecca Cramp, Irish Pharmaceutical Healthcare Association – How industry
views approval <strong>of</strong> clinical trials
Dr Rebecca Cramp spoke about <strong>the</strong> many benefits that an active clinical research programme can
bring to patients, hospitals, investigators, <strong>the</strong> pharmaceutical industry and <strong>the</strong> Irish economy at
large. She suggested that Ireland could have 400 industry clinical trials approved every year, if <strong>the</strong>
system was working well.
Rebecca said that while <strong>the</strong> Irish pharmaceutical industry was very keen to secure clinical trials,
Ireland has been losing out internationally in terms <strong>of</strong> attracting clinical trials due to:
A lack <strong>of</strong> predictability <strong>of</strong> time lines
Inadequate harmonisation <strong>of</strong> approach
Poor adherence to recruitment targets.
Rebecca listed many <strong>of</strong> <strong>the</strong> concerns raised by industry regarding <strong>the</strong> process <strong>of</strong> approving clinical
trials in Ireland which include:
Insufficient transparency in <strong>the</strong> process <strong>of</strong> hospital sign <strong>of</strong>f
Different procedures being applied in different hospitals for sign <strong>of</strong>f <strong>of</strong> <strong>the</strong> site specific
agreement (SSA)
Non-adherence to <strong>the</strong> Department <strong>of</strong> Health guidance document (2007) on SSA
Confusion in non-HSE hospitals as to <strong>the</strong> designated authority to sign <strong>of</strong>f on clinical trial
agreements
Additional fees being charged by some hospitals
Limit <strong>of</strong> liability per occurrence for clinical trials in Ireland being higher than in o<strong>the</strong>r
European countries and <strong>the</strong> USA
Great variation in pharmacy fees which ranged from €500 to €2,000 in 2011.
Rebecca explained that <strong>the</strong> three features which give a country competitive advantage in respect
<strong>of</strong> attracting industry clinical trials are:
A research hub – including investigators <strong>of</strong> world renown and excellent research nurses
Data quality
Speed/efficiency <strong>of</strong> approval processes.
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She said that Ireland had <strong>the</strong> first two features but needed to work on <strong>the</strong> speed and efficiency <strong>of</strong>
<strong>the</strong> approval process. Currently, hospital sign <strong>of</strong>f can take from two days to four months. She
added, “Delays are not about ethics or safety; <strong>the</strong>y are about administration”.
Rebecca suggested making <strong>the</strong> following improvements to <strong>the</strong> process:
Agreement by hospitals to adhere to <strong>the</strong> 2007 Department <strong>of</strong> Health and Children guidance
document on SSA
Clarity and transparency by <strong>the</strong> relevant authority to sign <strong>of</strong>f on clinical trial agreements in
all hospitals
Standardisation <strong>of</strong> limits <strong>of</strong> liability
Respect <strong>the</strong> requirement for a single ethical committee opinion <strong>of</strong> clinical trials
Standardisation <strong>of</strong> pharmacy fees
Standardisation <strong>of</strong> elements <strong>of</strong> <strong>the</strong> clinical trial agreements.
Rebecca’s full presentation can be accessed here.
Dr Rebecca Cramp, IPHA
Indemnity and Insurance <strong>of</strong> Clinical Trials
Colum Diamond, Aon Insurance and Advisor to <strong>the</strong> State Claims Agency – Practical
Advice and Lessons Learned
Colum presented an overview <strong>of</strong> <strong>the</strong> issues for sponsors in relation to <strong>the</strong> provision <strong>of</strong> appropriate
insurance and indemnity for clinical research. He affirmed that <strong>the</strong> state sponsored clinical
indemnity scheme (CIS) is not intended as an impediment to clinical research. The CIS covers
clinical research provided it has ethical approval and <strong>the</strong> sponsor’s responsibility for indemnity, as
set out in <strong>the</strong> HSE standard agreement, has been met. The only exception to this is ICORG, which
as a sponsor, is not required to sign <strong>the</strong> HSE Standard Form <strong>of</strong> Indemnity.
Colum emphasised that <strong>the</strong>re can be no reciprocal indemnities between sponsors and <strong>the</strong> CIS. On
ano<strong>the</strong>r point he noted that challenges may arise if an academic sponsor does not reside in or
have experience <strong>of</strong> working in Ireland, for example, an insurance certificate has to be issued by an
insurance company that is regulated to operate in Ireland. He confirmed that <strong>the</strong> CIS had recently
clarified that it covered <strong>the</strong> design and protocol <strong>of</strong> investigator-led trials sponsored by universities
that met <strong>the</strong> o<strong>the</strong>r criteria for indemnity. Private hospitals and <strong>the</strong>ir staff are not covered by <strong>the</strong> CIS
and thus require separate insurance.
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Colum referred to a case involving a multi-study sponsored by GSK which he considered as a
good example <strong>of</strong> best practice. GSK had sought his advice on <strong>the</strong> clinical trial agreement and had
circulated his letter approving <strong>the</strong> provisions to all <strong>the</strong> participating hospitals. This effectively
speeded up <strong>the</strong> approval process, and as he argued, represented one way <strong>of</strong> harmonising and
streamlining it. Colum suggested that guidelines are required on <strong>the</strong> issue <strong>of</strong> indemnity for <strong>the</strong>
sponsors <strong>of</strong> investigator-led trials and that policy makers need to be involved in agreeing <strong>the</strong>se
guidelines.
To access Colum’s full presentation please click here.
Towards harmonised approval <strong>of</strong> multi-centre clinical trials
Chair: Pr<strong>of</strong>essor Patrick Murray, UCD
As chair, Pr<strong>of</strong>essor Pat Murray opened <strong>the</strong> second session by referring to <strong>the</strong> objective <strong>of</strong>
streamlining <strong>the</strong> approval process for clinical trials in Ireland, which is to maximise opportunities for
Irish patients to gain access to new <strong>the</strong>rapies and diagnostics. He suggested that perhaps we
could develop common standard operating procedures (SOPs) for those issues on which <strong>the</strong>re is
agreement and define certain aspects or processes that could be harmonised. He noted that in
order to facilitate systematic change, it is useful at <strong>the</strong> outset to define both <strong>the</strong> baseline, that is
where you are today, and <strong>the</strong> ultimate goal.
Pat <strong>the</strong>n introduced Susan Lennon <strong>of</strong> MMI/ICRIN whose presentation on <strong>the</strong> initial findings <strong>of</strong> a
survey into how hospitals approve clinical trials had indeed defined <strong>the</strong> baseline. Following Susan,
he said that Jeremy Towns would describe a process that had been successful in developing a
standardised application form for <strong>the</strong> ethical approval <strong>of</strong> non-investigational medicinal product
studies, and that finally Joan McDonnell would conclude <strong>the</strong> session with examples <strong>of</strong> <strong>the</strong>
challenges to hospital approval from <strong>the</strong> hospital’s perspective and how <strong>the</strong>se might be overcome.
Susan Lennon, MMI/ICRIN - What would Harmonisation <strong>of</strong> Approval involve
Susan Lennon outlined <strong>the</strong> interim results <strong>of</strong> a HRB funded survey in which she has so far
conducted interviews with six out <strong>of</strong> a total sample <strong>of</strong> nine hospitals to determine <strong>the</strong> process
<strong>of</strong> multi-centre drug trial approval and <strong>the</strong> challenges experienced in each hospital. Susan
reported that <strong>the</strong>re was variability in <strong>the</strong> process <strong>of</strong> review and <strong>the</strong> documentation required
and suggested that <strong>the</strong>re was potential for improving <strong>the</strong> process, specifically in <strong>the</strong> following
areas:
Agreement on documentation required for SSA sign <strong>of</strong>f
Agreement on <strong>the</strong> common elements <strong>of</strong> a clinical trial agreement, and
Development <strong>of</strong> a forum for sharing best practice.
Susan’s presentation can be accessed here.
Jeremy Towns, MMI/Dublin Centre for Clinical Research – Why Harmonise
Hospital Approval
Jeremy Towns outlined <strong>the</strong> steps involved in agreeing, designing and disseminating a
standard application form for <strong>the</strong> ethical approval <strong>of</strong> non drug clinical trials, which <strong>the</strong> majority
<strong>of</strong> research ethics committees have now adopted. He suggested that this process provides a
model for moving forward towards agreed improvements in <strong>the</strong> process <strong>of</strong> hospital approval <strong>of</strong>
clinical trials.
Jeremy’s presentation is available here.
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Joan McDonnell, St Vincent’s University Hospital – The Challenge <strong>of</strong> Harmonised
Approval: A Hospital Perspective
Joan Mc Donnell spoke about <strong>the</strong> challenges <strong>of</strong> harmonising approval <strong>of</strong> clinical trials from a
hospital perspective. She referred to <strong>the</strong> important objective <strong>of</strong> <strong>the</strong> approval process which is to
protect patients and staff. She said that <strong>the</strong> HSE Standard Form <strong>of</strong> Indemnity and <strong>the</strong> standard
application form for clinical trial applications are both working well at <strong>the</strong> moment.
Joan suggested that areas for improvement include:
Independent advice for PIs on <strong>the</strong>ir responsibilities for clinical trials
Harmonisation <strong>of</strong> clinical trial agreements based on <strong>the</strong> best current clinical trial
agreements
Standardisation <strong>of</strong> <strong>the</strong> process for local site approval
Ensuring synergies between <strong>the</strong> work done to date by MMI on <strong>the</strong> harmonisation <strong>of</strong> clinical
trial processes, including <strong>the</strong> standard application form and <strong>the</strong> work being done by Health
Information and Quality Authority (HIQA) in developing standards for ethics committees.
Joan suggested <strong>the</strong>re was a need for an independent body to inform and educate PIs on what is
involved in signing <strong>of</strong>f as a sponsor, and she stressed that <strong>the</strong> biggest issues when reviewing
clinical trial agreements are issues <strong>of</strong> indemnity and responsibility.
Joan’s presentation can be accessed here.
Left to right: Jeremy Towns, MMI/DCCR, Joan McDonnell, St Vincent’s University Hospital,
Susan Lennon, MMI/ICRIN, Pr<strong>of</strong>essor Patrick Murray, UCD and Siobhan Gaynor, MMI/ICRIN
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Open Discussion
Chaired by Pr<strong>of</strong>essor Patrick Murray, UCD
1. Limit <strong>of</strong> liability
The limit <strong>of</strong> liability required in Ireland (€6.5 million) is significantly higher than in o<strong>the</strong>r European
countries and <strong>the</strong> USA and many attendees questioned <strong>the</strong> need for higher coverage in Ireland.
Ciaran Breen explained that in Ireland <strong>the</strong>re is a history <strong>of</strong> very high compensation awards for
medical malpractice cases, and as a result, <strong>the</strong> level <strong>of</strong> coverage required was necessarily higher.
He accepted that in <strong>the</strong> case <strong>of</strong> clinical research in particular <strong>the</strong>re is no case law in relation to <strong>the</strong>
awarding <strong>of</strong> compensation by Irish Courts and thus <strong>the</strong> limits were based on awards in clinical
malpractice cases.
2. Standardised Clinical Trial Agreements (CTAs)
Whilst it may not be possible for all pharmaceutical companies to adhere to a standard Irish
template, given <strong>the</strong> global reach <strong>of</strong> <strong>the</strong>ir activities and individual requirements, it may be possible to
explore <strong>the</strong> insertion <strong>of</strong> some standardised wording in <strong>the</strong> relevant sections. In addition, it may be
possible to gain agreement on what should be included in <strong>the</strong> CTA and what should not, for
example, issues relating to insurance and indemnity. The possibility <strong>of</strong> agreeing a standard CTA
for investigator-led trials was also raised. An initiative to clarify <strong>the</strong> name required by all hospitals in
relation to “Authority” would be welcomed by all.
3. Investigator-led clinical trials
Much discussion ensued about <strong>the</strong> issue <strong>of</strong> academic sponsors <strong>of</strong> drug clinical trials and <strong>the</strong>
responsibilities <strong>of</strong> sponsors and PIs <strong>of</strong> such studies under <strong>the</strong> EU Clinical Trials Directive. It was
acknowledged that this is a new and growing area in Irish clinical research and clarity as to <strong>the</strong>
scope <strong>of</strong> coverage under <strong>the</strong> CIS for activities in relation to clinical trial design oversight and
responsibilities should be sought and disseminated widely.
4. Patient involvement in clinical trials
There is a need to highlight to patients as well as to <strong>the</strong> health service, <strong>the</strong> value <strong>of</strong> involvement in
clinical research, <strong>the</strong> potential benefits <strong>of</strong> which include improving patient recruitment to clinical
trials, improving patient access to clinical trials, removing some <strong>of</strong> <strong>the</strong> administrative hurdles and
securing improved funding for clinical research. Participants pointed out that patients would be
concerned to know that administrative hurdles, rules about legal jurisdiction and an absence <strong>of</strong>
standard pharmacy fees are reducing opportunities to participate in clinical trials <strong>of</strong> benefit to <strong>the</strong>m
or to o<strong>the</strong>r patients.
5. Single opinion for non-interventional studies
Some participants suggested that hospitals and research ethics committees should agree a single
opinion for multi-centre, non-interventional clinical studies, on <strong>the</strong> model <strong>of</strong> that in place for
interventional trials. It was agreed that HIQA could play an important role in achieving such a goal.
6. Ireland as <strong>the</strong> legal jurisdiction for dispute resolution
The requirement that Ireland is <strong>the</strong> jurisdiction in which any dispute under <strong>the</strong> CTA must be settled
was raised by a number <strong>of</strong> participants. A number <strong>of</strong> people made <strong>the</strong> point that this restriction was
making it very difficult for academic investigators to participate in European studies, including those
funded by <strong>the</strong> EU. O<strong>the</strong>r countries appeared to be perfectly happy to use Belgium and Belgian law
for <strong>the</strong> resolution <strong>of</strong> clinical trial disputes. Ciaran Breen referred to <strong>the</strong> policy that under current
arrangements <strong>the</strong> CIS could not indemnify investigators in a multi-national trial if <strong>the</strong> jurisdiction
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was not Ireland. However, this was <strong>the</strong> first time that <strong>the</strong> CIS had been made aware <strong>of</strong> <strong>the</strong> problem
and he undertook to examine it. Ciaran agreed that a way forward might be to draw a distinction
between commercial and investigator-led studies and he said that <strong>the</strong> issue would have to be
referred to <strong>the</strong> Attorney General for advice.
Next Steps and Close <strong>of</strong> <strong>Workshop</strong>
Siobhan Gaynor, MMI/ICRIN,
Siobhan Gaynor closed <strong>the</strong> workshop by thanking <strong>the</strong> chairs and speakers for <strong>the</strong>ir stimulating
presentations and comments, participants for <strong>the</strong>ir active involvement and MMI colleagues for
organising <strong>the</strong> event. She also thanked AON Insurance for <strong>the</strong>ir sponsorship <strong>of</strong> <strong>the</strong> lunch.
Siobhan outlined some <strong>of</strong> <strong>the</strong> ways which ICRIN and MMI could help to resolve some <strong>of</strong> <strong>the</strong> issues
discussed:
Establish a working party <strong>of</strong> interested members from <strong>the</strong> hospitals, ethics committee and
research community to progress issues in relation to <strong>the</strong> process <strong>of</strong> hospital approval <strong>of</strong>
multi-centre clinical trials
Work with <strong>the</strong> States Claims Agency to clarify <strong>the</strong> scope <strong>of</strong> coverage <strong>of</strong> <strong>the</strong> Clinical
Indemnity Scheme and disseminate communications to <strong>the</strong> Irish clinical research
community
Continue to engage with all stakeholders and ensure that knowledge, developments,
processes and services are available to all.
APPENDIX 1
MMI/ICRIN <strong>Workshop</strong> on Hospital Approval <strong>of</strong> Clinical Trials - January
26 th 2012
Background
Significant investment is underway to build capacity in Ireland to undertake clinical research and
MMI is working to maximise return on that investment. The Irish Clinical Research Infrastructure
Network (ICRIN), established by MMI and funded by <strong>the</strong> HRB, Enterprise Ireland and <strong>the</strong> EU, is
developing <strong>the</strong> harmonised processes and providing <strong>the</strong> training, regulatory advice and
consultancy services required to facilitate multi-centre clinical studies in Ireland and Europe. The
Dublin Centre for Clinical Research (DCCR), funded by <strong>the</strong> HRB and <strong>the</strong> Wellcome Trust and
supported by MMI, has created a network for clinical research involving Trinity College, University
College Dublin, <strong>the</strong> Royal College <strong>of</strong> Surgeons in Ireland and <strong>the</strong>ir associated hospitals.
MMI, through its ICRIN and DCCR activities, has been working to make it easier to conduct multicentre
clinical studies in Ireland. For example, MMI coordinated an initiative to agree a standard
application form for <strong>the</strong> ethical approval <strong>of</strong> non investigational medicinal products research studies.
The result was a standard on-line form, which has greatly simplified <strong>the</strong> process and effort required
when applying to multiple research ethics committees for approval <strong>of</strong> multi-centre studies. Building
on this progress, work is underway to standardise patient information and patient consent
procedures. In 2008, MMI assisted <strong>the</strong> research community by organising a workshop with <strong>the</strong>
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State Claims Agency that clarified <strong>the</strong> extent <strong>of</strong> clinical indemnity cover for clinical research
studies, including multi-centre studies.
MMI is currently examining <strong>the</strong> process by which hospitals approve <strong>the</strong> conduct <strong>of</strong> clinical trials
involving <strong>the</strong>ir staff and patients following ethical approval. The aim <strong>of</strong> MMI’s enquiries is to explore
<strong>the</strong> possibility <strong>of</strong> simplifying and harmonising procedures for approval <strong>of</strong> multi-centre studies. In <strong>the</strong>
course <strong>of</strong> that initiative, it became apparent that differing considerations are brought to bear in
each hospital in approving participation in clinical research and that differing interpretations have
arisen. While <strong>the</strong> HSE Clinical Trials Indemnity Form provides a standard agreement between
pharmaceutical companies and o<strong>the</strong>r sponsors <strong>of</strong> clinical research and <strong>the</strong> hospitals on indemnity,
<strong>the</strong>re is scope for greater clarity on <strong>the</strong>:
Nature <strong>of</strong> studies covered by <strong>the</strong> agreement,
Appropriateness <strong>of</strong> insurance cover,
Circumstances when external insurance expertise may be required,
Legal jurisdiction that governs a study,
Implications <strong>of</strong> a study for hospital resources,
Patient privacy and confidentiality considerations that should apply.
Particular issues appear to arise in relation to participation by a hospital in a clinical trial sponsored
by academic institutions in o<strong>the</strong>r jurisdictions. In future, <strong>the</strong>re are likely to be more multi-centre,
multi-national clinical trials sponsored by Irish academic institutions or academic institutions in
o<strong>the</strong>r jurisdictions, which will raise novel challenges for those involved in hospital approval.
MMI organised a half-day workshop to explore <strong>the</strong> issue <strong>of</strong> Hospital Approval <strong>of</strong> Clinical Trials on
Thursday 26 January, which was held in <strong>the</strong> Physics Theatre, Newman House, 85 St Stephen’s
Green, Dublin 2. The workshop explored <strong>the</strong> challenges <strong>of</strong> hospital approval <strong>of</strong> participation in
clinical trials and assessed interest in moving towards a harmonised approach to approval <strong>of</strong> multicentre
studies. The workshop provided an opportunity for those most directly involved in assessing
clinical trial applications in hospitals to engage with experts in medical indemnity and insurance, to
review issues that arise in hospital approval, to share <strong>the</strong>ir experiences with each o<strong>the</strong>r and to
explore <strong>the</strong> challenges <strong>of</strong> developing a harmonised approach to approval <strong>of</strong> multi-centre trials.
<strong>Workshop</strong> Programme
Welcome and Introduction to <strong>Workshop</strong>
Dr Ruth Barrington, CEO, MMI
Approval <strong>of</strong> Clinical Trials - Hospital and Industry Perspectives
Chair: Mr Ciaran Breen, Director, State Claims Agency
Speakers: Ms Muireann O Briain, Legal and Risk Officer, St James’s Hospital, Dublin
- What a hospital needs to know about a clinical trial
Dr Rebecca Cramp, IPHA - How Industry views approval <strong>of</strong> Clinical Trials
Indemnity and Insurance <strong>of</strong> Clinical Trials
Speaker: Mr Colum Diamond, AON Insurance - Clinical Trials - Insurance and Indemnity -
Practical Advice and Lessons Learned
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Towards harmonised approval <strong>of</strong> multi-centre clinical trials
Chair: Pr<strong>of</strong>essor Patrick Murray, Pr<strong>of</strong>essor <strong>of</strong> Clinical Pharmacology UCD
Speakers: Susan Lennon, Clinical Trials Manager, ICRIN/MMI - What would harmonisation <strong>of</strong>
approval involve
Jeremy Towns, Programme Manager, DCCR - Why harmonise hospital approval
Joan McDonnell, Senior Administrator, Ethics and Medical Research Department.
St Vincent’s University Hospital, Dublin - The Challenge <strong>of</strong> Harmonised Approval - A Hospital
Perspective
Next steps and close <strong>of</strong> workshop
Siobhan Gaynor, Programme Manager, Clinical and Translational Research, MMI/ICRIN
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