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