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Ireland – A Location of Choice for Medical Technology Clinical Investigations ‘ICORG – Proof of Concept’ Brian Moulton, CEO, ICORG . What is ICORG . Investigator run not-for-profit o ncology c linical t rials organisation –
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Ireland – A Location of Choice for Medical Technology Clinical Investigations‘ICORG – Proof of Concept’ Brian Moulton, CEO, ICORG
What is ICORG • Investigator run not-for-profit oncology clinical trials organisation – • Membership = 416 including 98% of All Cancer Treating Specialists on the Island • US Training • Founded 1997 • Collaborations with both European and US Cooperative Groups, e.g. only European member of NSABP and ECOG • Many long term Pharmaceutical Co. collaborations
HRB ESARB All DSSGs report to the SMG All DSSG meetings are open access to all ICORG members ICORG MEMBERSHIP
ICORG ORGANOGRAM 20 Staff with combined more than 100 years specialised oncology clinical research experience
Patient Contribution • Inlast 3years: 4006patients enrolled on ICORG designed or adopted trials • Approximate Breakdown: 1000 intern. collaborative group, 2000 local ICORG designed studies, 1000 industry adopted studies • Today: 3329 patients are currently on trial on 98 active studies (actively being treated or in follow-up)
ICORG Portfolio 2011 Disease Specific Sub-Groups (DSSG) for all areas including CNS, Paediatric and Translational
ICORG Collaborators Anglo-Celtic.org.uk A C O S O G
many years before they became or will become standard of care Within 15.7 years: > 30Different treatments have been made available to cancer patients in Ireland in multiple disease areas via ICORG trials • Taxotere • Imatinib • Trastuzumab • Lapatinib • Ipilimumab • Nilotinib • 3D Conformal Radiotherapy • Intensity Modulated Radiotherapy • Abiraterone • GSK 436 BRAF Inhibitor • Crizotinib • Sunitinib
Breast Cancer Health Outcomes 5-year survival rate increased from 70% to 80.6% between 1997 and 2007 • Source: Latest annual report, Cancer in Ireland 2011, published by NCRI Coincided with period when ICORG opened 33 research protocols • Providing access to promising new treatments for more than 1,800 Irish breast cancer patients, treatments otherwise only available in US and elsewhere • Success of research protocols led to accelerated access to new treatments for the general cancer population
ICORG Peer-Reviewed Published Literature as of April 2012: 1) ICORG 04-01: ‘AZURE’ BIG01/04study: N Engl J Med. 2011 Oct 13;365(15):1396-1405. October 13, 2011. 2) ICORG 01-03: BCIRG 006 study: N Engl J Med 2011; 365: 1273-1283. October 6, 2011 3) ICORG 04-08: EGF100151 study: N EnglJ Med, 2006; 355 (26): 2733-2743. 1) ICORG 06-06: CIRG/TORI 010 study: The Lancet Oncology, Volume 12, Issue 4, Pages 369 - 376, 01/04/2011 2) ICORG 06-07: COIN study: Lancet Oncol. 2011 Jul;12(7):642-53. Epub 2011 Jun 5 1) ICORG 01-04: BCIRG 005 study: J ClinOncol. 2011 Oct 10;29(29):3877-84. Epub 2011 Sep 12 2) ICORG 01-09: BCIRG 007 study: J ClinOncol. 2011 Jan 10;29(2):149-56. Epub 2010 Nov 29. 3) ICORG 04-09: EGF30008 study: J Clin Oncol. 2009 Nov 20;27(33):5538-46. Epub 2009 Sep 28. 4) ICORG 97-01 study: J ClinOncol. Published ahead of print on 31 Oct. 2011 as 10.1200/JCO.2011.37.0726. 5) ICORG 05-02: NSABP C-08 study:J ClinOncol., Vol 27, No 20 (July 10),2009: pp3385-3390 6) ICORG 05-02: NSABP C-08 study:J ClinOncol. 2011 Jan 1;29(1):11-6. Epub 2010 Oct. 1) ICORG 98-01: BIG 02-98 study: J Natl Cancer Inst 2008; 100: 121-133. 2) ICORG 97-02: Anglo-Celtic Group ‘ACCOG-1’ study: J Natl Cancer Inst (2004) 96 (14): 1076-1083 ICORG 97-02: Anglo-Celtic Group ‘ACCOG-1’ study: Breast Cancer Res Treat. 2010 Aug;122(3):787-94. Epub 2010 Jun 18 ICORG 04-08: EGF100151 study: Breast Cancer Research and Treatment 2008. Volume 112, Number 3, 533-543 1) ICORG 97-01 study: Int. J. Radiat. Oncology Biol. Phys., 2011 Sep 1;81(1):35-45. Epub 2010 Aug 25. 2) ICORG 97-01 study:Int J RadiatOncolBiol Phys. 2011 Jun 1;80(2):608-13. Epub 2010 Oct 8. 1) ICORG 00-01: Epilymph study: Int J Cancer. 2006 Aug 15;119(4):901-8 2) ICORG 07-12: Collaborative Biomarker study: Int J Cancer. 2011 Sep 27. [Epub ahead of print] ICORG 04-01: ‘AZURE’ BIG01/04study: British Journal of Cancer (2010) 102, 1099–1105 ICORG 98-01: BIG 02-98 study: Ann Oncol 2008 Nov; 19(11) 1837-41. Epub 2008 Jun 18 ICORG 06-03: Phase 1 Epi-sulindac study: Cancer ChemotherPharmacol. 2007 Jan;59(1):79-87 ICORG 99-09: Med Dosim. 2010 Spring;35(1):38-42.Epub 2009 Feb 7.
ICORG ‘Device’ Experience TAILORx
Regulatory • Assessed by IMB as being a device • ICORG completed the CE marking process • Then submitted as a clinical trial
30% of all possible eligible patients accrued • 6% of total study accrual • 16% of ECOGs accrual
975 Sites worldwide 2nd Highest Worldwide
975 Sites worldwide 3 of top 15
975 Sites worldwide 10 of the top 100
Partnership Industry partners Clinical Assessment Data Management Statistics CT Monitoring TCD Bio Resources Hospitals