Annual Report 2010

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The Clinical Research Centre
Royal College of Surgeons in Ireland
2000 - 2010
Advancing our knowledge of disease mechanisms and evaluating therapies
Our Vision
The CRC is committed to providing state-of-the-art facilities and equipment to facilitate research,
and vertical integration in partnership with academic experts and the commercial sector in
order to gain a better understanding of how drugs work on humans, and to develop
life-enhancing therapies through clinical trials and basic research.
The driving force of the CRC is excellence in patient-orientated research.
Multi-purpose
medical centre
a first
The Royal College of Surgeons in Ireland has
opened a £10 million research facility on the
grounds of Beaumont Hospital in Dublin. The
Education and Research Centre is a centre “for
patient-oriented research,” explains Dr Dermot
Kenny, Director of the Clinical Research Centre, which forms part of the Education and Research Centre of the College.
“It is the first of its kind here. It is a fantastic development for the country.” The centre
has been designed so as to link together three
strands: medical research, clinical practice and
the education of doctors, he said.
The Irish Times
Monday 9th Sept 2000
Clinical Research Centre,
Royal College of Surgeons in Ireland (RCSI)
2010 marks the 10-year anniversary of the opening of the
clinical research centre of RCSI. In that time the centre has
grown significantly and now has a core staff of 15 research
nurses in addition to administrative and IT support. The
centre was established to advance translational research,
which is the transfer of knowledge from science to patient
care and the understanding of disease to inform basic
science. In the last decade there has been more than 13,000 patient visits to the
centre for clinical trials in many different areas. Thus the concept of translational
research has been effectively delivered. It is particularly gratifying to hear the reports
from many different patients on the standard of care they have received and how they
feel the centre has played a positive role for them.
This decade has seen unique challenges with regulatory requirements, strains on
health care systems and increasing complexity of basic research to deliver on our vision
of enhanced patient care through cutting edge research. Despite these challenges
the center has now been recognized by regulatory authorities, funding agencies and
industry for it’s unique expertise, especially in the area of cardiovascular, respiratory,
neurology, endocrine and rheumatology research.
The staff of the centre together with the patients they have cared for are justifiably
proud of their accomplishments in the last decade and look forward to delivering the
best in advanced care to their patients in the future.
Dermot Kenny, MD, FACC, FRCPI,
Director, Clinical Research Centre
Clinical Research Centre, RCSI
The RCSI Clinical Research Centre celebrates it ten year anniversary this year. This
has been a very exciting time for the CRC, during which we have been on a journey
of learning and development. We can proudly say that we have built a busy research
unit, developed our expertise in research in a wide variety of therapeutic areas as
well as building and developing a staff of excellent and experienced research nurses.
However our most important achievement is our contribution to the care of every
patient who has stepped through the doors of this centre.
We continue to work with our many loyal Beaumont Hospital investigators in the
delivery of high quality clinical research. In addition, as a centre we collaborate with
the wider research community through a number of research networks including the
Dublin Centre for Clinical Research and the Irish Clinical Research Infrastructure
Network, to which we endeavour to contribute the knowledge and experiences we
have gained over the past ten years.
The RCSI Post Graduate Course in Clinical Research for Nurses is in its second year.
The CRC has continued its commitment to research nurse education and professional
development by being instrumental in the development of this course. One of our
senior research nurse’s is the course coordinator and a number of our nurses bring
the expertise we have developed over the past ten year’s to the course, in the delivery
of lectures to students.
We look forward to continuing to grow and develop this important facility over the
next ten years.
Ailbhe Cullen, MSc,
Director of Nursing, Clinical Research Centre
Research Achievements in the CRC
Professor Orla Hardiman
Consultant Neurologist
The Irish Register of Motor Neurone Disease has been housed in the CRC for
the past 10 years, and using this resource we have made a number of significant
breakthroughs in our understanding of the disease. The CRC has also provided a
world class infrastructure that has enabled large number of Phase II and Phase III
trials in MND, Multiple Sclerosis, Parkinson’s Disease and Migraine. Over the years,
the Centre has developed an international reputation for excellence in the delivery
of clinical trials.
We look forward to the next 10 years of our association with the CRC, and
congratulate the staff on this important milestone in the pursuit of excellence in
clinical research.
Professor Richard Costello
Consultant in Respiratory Medicine
I have used the CRC to start two multicentre investigator led device studies. These
are the first such studies to be done in the RCSI/Smurfit and both are 200 subject
trials. The staff prepared clinical protocols, PlL’s, consent documents, risk and
safety documents, IMB applications (120 page applications), organised site visits,
data monitoring reviews and ethics submissions revisions and co-coordinated other
site’s ethics applications and multicentre briefing meeting and training meeting.
The staff have also been involved in other major studies, one looking a remote
monitoring of lung function and the other an industry sponsored study in patients
with COPD.
Finally, I have been very impressed with the professional approach of all staff,
it is a pleasure to interact with the staff at a personal level.
Professor Gillian Murphy
Consultant Dermatologist
Over the past decade we have been looking at genetic risk factors for skin cancer and our
understanding of those risk factors has greatly improved. The research in Mary Laing’s
thesis was built on findings from research in the CRC. The CRC has also facilitated the
maintenance of a skin cancer data base and a melanoma data base which is a valuable
resource for our research.
“I can go and do what I want to do.
Last year my MS was dismal.
Now I feel that I can walk, I can talk,
I can study, I’m back to being me again.”
Jennifer Moran,
A Patient from the Clinical Research Centre
Research Achievements in the CRC
Professor Alice Stanton,
Investigator
Over the past 10 years, the CRC has enabled my clinical research group to look after in
excess of 1000 patients within a number of
major international cardiovascular clinical trials, including;
· Anglo Scandinavian Cardiac Outcomes Trial, (ASCOT, )
· Action in Diabetes and Vascular Disease (ADVANCE, )
· ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial (OnTARGET)
These trials have had significant impact on changing the management of cardiovascular
disease worldwide.
Professor David Foley
Consultant Cardiologist
The division of cardiology has run several academic and pharmaceutical trials through the
CRC. The strong interaction of basic scientists with cardiology has produced our first PhD
clinician scientists and key papers that have resulted in successful MD awards. In the next
decade we look forward to translating our research into meaningful patient outcomes.
Dr. Paul O’Connell,
Consultant Rheumatologist
The rheumatology service in Beaumont has used the Clinical Research Centre as our
site for Phase 2 and 3 studies of new and evolving biological and other therapies in
Rheumatoid arthritis for much of the past 10 years. It has allowed us to participate
in important studies that otherwise we would not have been able to undertake. The
standards maintained by the CRA’s in the CRC is of a consistently high level and the
backup facilities are excellent. We have had excellent retention in our studies due to the
level of personal attention given to study subjects. The meticulous attention to detail by
the CRA’s means that audits of our studies are always passed with flying colours.
For a relatively small specialty such as rheumatology the CRC is the difference between
participating in pharmacological studies and not being able to.
4
Research Nurse Training and Education
The CRC is committed to the education and training of clinical research nurses who
can actively participate in all aspects of clinical research. In the absence of any formal
programme of education for clinical research nurses we sought to fill this gap. In
collaboration with the Dublin Centre for Clinical Research (DCCR), through a grant
supported by the Health Research Board (HRB) the first course for research nurses
was developed. Professor Seamus Cowman and Ms Ailbhe Cullen, Nurse Manager of
the CRC, developed the curriculum documents for a Certificate in Nursing (Clinical
Research) programme, which was approved by the NUI and started in The Faculty
of Nursing and Midwifery, RCSI in September 2009. This postgraduate programme,
which leads to a Minor Award at Level 9, consists of three modules: Clinical Research
Design & Methodology; Ethics and Regulatory Affairs and Clinical Research Practice
& Management. Modules can be undertaken as stand-alone programmes for academic credit.
The programme is coordinated by Ms Deirdre Hyland, a member of staff in the CRC.
5
Representative Publications
Human IgG antibody profiles differentiate between symptomatic patients with and
without colorectal cancer.
Kijanka G, Hector S, Kay EW, Murray F, Cummins R, Murphy D, MacCraith BD, Prehn JH, Kenny D.
Gut. 2010 Jan;59(1):69-78.
Language, motor and speed of processing deficits in adolescents with subclinical
psychotic symptoms.
Blanchard M, Jacobson S, Clarke M, Connor D, Kelleher I, Garavan H, Harley M, Cannon M.
Schizophrenia Research. 2010 Oct;123(1):71-76.
17β-estradiol inhibits IL-8 in cystic fibrosis by up-regulating secretory leucoprotease
inhibitor.
*Chotirmall SH, *Greene CM, Oglesby IK, Thomas W, O’Neill SJ, Harvey BJ,
McElvaney NG.
Am J Respir Crit Care Med. 2010 Jul 1;182(1):62-72. Impact of statin therapy on central aortic pressures and hemodynamics: principal
results of the Conduit Artery Function Evaluation-Lipid-Lowering Arm (CAFE-LLA)
Study.
Williams B, Lacy PS, Cruickshank JK, Collier D, Hughes AD, Stanton A, Thom S, Thurston H;
CAFE and ASCOT Investigators.
Circulation. 2009 Jan 6;119(1):53-61.
An assessment of the Irish population for large-scale genetic mapping studies involving epilepsy and other complex diseases.
O’Dushlaine CT, Dolan C, Weale ME, Stanton A, Croke DT, Kalviainen R, Eriksson K, Kantanen AM, Gibson RA, Hosford
D, Sisodiya SM, Gill M, Corvin AP, Morris DW, Delanty N, Cavalleri GL.
Eur J Hum Genet. 2008 Feb;16(2):176-83.
Differential expression of matrix metalloproteinase (MMP)-2, MMP-9 and tissue
inhibitor of metalloproteinase (TIMP)-1 and TIMP-2 in non-melanoma skin cancer:
implications for tumour progression.
O’Grady A, Dunne C, O’Kelly P, Murphy GM, Leader M, Kay E.
Histopathology. 2007 Dec;51(6):793-804.
Multicentre search for genetic susceptibility loci in sporadic epilepsy syndrome and
seizure types: a case-control study.
Cavalleri GL, Weale ME, Shianna KV, Singh R, Lynch JM, Grinton B, Szoeke C, Murphy K,
Kinirons P, O’Rourke D, Ge D, Depondt C, Claeys KG, Pandolfo M, Gumbs C, Walley N,
McNamara J, Mulley JC, Linney KN, Sheffield LJ, Radtke RA, Tate SK, Chissoe SL,
Representative Publications Continued
Gibson RA, Hosford D, Stanton A, Graves TD, Hanna MG, Eriksson K, Kantanen AM,
Kalviainen R, O’Brien TJ, Sander JW, Duncan
JS, Scheffer IE, Berkovic SF, Wood NW, Doherty CP, Delanty N, Sisodiya SM, Goldstein DB.
Lancet Neurol. 2007 Nov;6(11):970-80.
Photochemotherapy and methotrexate used to treat generalized cutaneous
scleroderma.
Ridge CA, Moktar A, Barry J, Murphy GM.
J Eur Acad Dermatol Venereol. 2007 May;21(5):692-3.
Recurrence of Kawasaki disease in an adult patient with cholecystitis.
McMahon MA, Wynne B, Murphy GM, Kearns G.
Ir Med J. 2007 Mar;100(3):400-1.9.
Role of the muscarinic M2 receptor in human nasal mucosa.
Sheahan P, Thornton M, Walsh RM, Walsh MA, Costello RW.
Rhinology. 2007 Sep;45(3):229-34.
Screening for lung cancer using low dose CT scanning: results of 2 year follow up.
MacRedmond R, McVey G, Lee M, Costello RW, Kenny D, Foley C, Logan PM.
Thorax. 2006 Jan;61(1):54-6.
Screening for lung cancer using low dose CT scanning.
MacRedmond R, Logan PM, Lee M, Kenny D, Foley C, Costello RW.
Thorax. 2004 Mar;59(3):237-41.
ontinued
Posterior pituitary dysfunction after traumatic brain injury.
Agha A, Thornton E, O’Kelly P, Tormey W, Phillips J, Thompson CJ.
J Clin Endocrinol Metab. 2004 Dec;89(12):5987-92
Platelet surface glycoprotein expression in post-stroke depression: a preliminary
study.
Cassidy EM, Walsh MT, O’Connor R, Condren RM, Ryan M, O’Keane V, Kenny D, Dinan T.
Psychiatry Res. 2003 May 30;118(2):175-81.
Elevated expression of integrin alpha(IIb) beta(IIIa) in drug-naïve, first-episode
schizophrenic patients.
Walsh MT, Ryan M, Hillmann A, Condren R, Kenny D, Dinan T, Thakore JH.
Biol Psychiatry. 2002 Nov 1;52(9):874-9.
7
Research Contact
Details
Dr Gillian Murphy
Dr. Diarmuid Smith
Dr Norman Delanty
Dr Orla Hardiman
Prof. Gerry McElvaney
Prof. Richard Costello
Dr. Paul O’Connell
Endocrinology Neurology
Respiratory
Rheumatology
Deirdre Hyland, RN
Grace Mullins, RN
Elaine MacHale, RN
Brenda Liggan, RN
Catherine Lynch, RN
Claire Foley, RN Dr. Mary Laing
T: 809 3785 E:dhyland@rcsi.ie
T: 809 3876 E:gracemullins@rcsi.ie
T: 809 3779 E:elainemachale@rcsi.ie
T: 809 3786 E:bliggan@rcsi.ie
T: 809 3787 E:clynch@rcsi.ie
T:809 3783 E: cfoley@rcsi.ie
T: 809 3787 E:marylaing@rcsi.ie
Internal Medicine
Ailbhe Cullen, RN
T: 809 3790 E:acullen@rcsi.ie
Claire Foley, RNT: 809 3782
E:cfoley@rcsi.ie
Deirdre Hyland, RNT: 809 3785
E:dhyland@rcsi.ie
Maureen Brenan, RNT: 809 3787
E:marueenbrenan@rcsi.ie
Helen Doherty, RNT: 809 3779
E:helendoherty@rcsi.ie
Specialty Research ContactDetails
General Research Contacts in the Clinical Research Centre
Dermatology
Cardiovascular
Prof. David Foley
Fiona McGrath, RN
T: 809 3782 E:fmcgrath@rcsi.ie
MedicineSiobhan McFadden, RN
T: 809 3782 E:siobhanmcfadden@rcsi.ie
Prof. Dermot Kenny
Gail Plunkett, RN
T: 809 3790 E:gailplunkett@rcsi.ie
Prof. Alice Stanton
Benita Maguire, RN
T: 809 2862 E:benitamaguire@rcsi.ie
Kathleen Shortall, RNT: 809 2862 E:kathleenshortall@rcsi.ie
Kevin Barrett, RNT: 809 2862 E:kevinbarrett@rcsi.ie
Principle Investigator Major Research Themes in the Clinical Research Centre
RCSI Clinical
Research Centre
RCSI Clinical Research Centre,
Education & Research Centre,
Smurfit Building, Beaumont Hospital,
Dublin 9, Ireland.
Tel: + 353 1 809 3781
Fax: + 353 1 809 3809
Email: crc@rcsi.ie
www.rcsi-crc.ie
Useful links:
www.rcsi.ie
www.alpha1.ie
www.bdi.ie
www.mnd.ie
www.beaumontethics.ie
www.molecularmedicineireland.ie
LEADING DEVELOPING INNOVATING
EDUCATING RESEARCHING
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