MEETING AGENDA.doc

MEETING AGENDA14th December 2004VENUE:Rooms Go5 & Go6133 Molesworth streetWellington Members of the public may attend the open section of the meeting, which commences at 11.00 am.Meeting of the Multi-region Ethics Committee open to the public to be held on Tuesday 14th December 2004 at the Ministry of Health 133, Molesworth Street, Wellington at 11.00 am.PRESENT:Martin Tolich (Chairperson)Dr Cynthia DarlingtonMrs Maliaga ErickDr Jane Koziol-McLainDr Fiona McCrimmonProf. Graham MellsopDr Barry SmithDr Lois SurgenorDr Sheila WilliamsDr Christopher WynneMrs. Janine AhieADMINISTRATOR:Sheryl KirikiriAPOLOGIES:Mrs Carolyn Weston CHAIRPERSONS REPORTNEW PROTOCOLS1.A randomized, three arm, multinational, phase III study to investigate Bevacizumab (q3w or q2w) in combination with either intermittent Capecitabine plus Oxaliplatin (XELOX) (q3w) or Fluorouracil/Leucovrin with Oxaliplatin (FOLFOX-4) versus FOLFOX regimen alone as adjuvant chemotherapy in Colon Carcinoma, Protocol Number BO17920, Version A.Main Site:AucklandPrimary Investigator:Dr Paul ThompsonMEC Ref:04/12/0012.A comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects who are to Undergo Percutaneous Coronary Intervention/TIMI-38. Main Site:Auckland Primary Investigator:Dr David RitchieMEC Ref:04/12/0023. Chronic liver disease and hepatocellular carcinoma mortality attributable to hepatitis B and C in New Zealand: The changing burden of disease.Main Site: CanterburyPrimary Investigator:Dr Emma DavidsonMEC Ref:04/12/0034. MRI to monitor the effect of zoledronic acid therapy in erosive psoriatic arthritis.Main Site:AucklandPrimary Investigator:Fiona Mc QueenMEC Ref:04/12/0045.Unlinked anonymous HIV prevalence study among sexual health clinic attenders. Main Site:Wellington Primary Investigator:Nigel DicksonMEC Ref:04/12/0056.An Open Label, Randomised, Phase II Study of DMXAA in Combination with Carboplatin and Paclitaxel in patients with Platinum-sensitive recurrent ovarian epithelial cancer.Main Site:Waikato Primary Investigator:Dr Michael Jameson MEC Ref:04/12/0067.A Multicentre, Randomised, Controlled, Prospective parallel group trial to determine whether treatment by peritoneal dialysis using a low glucose degradation products (GDP) and neutral pH peritoneal dialysis (PD) solution (Balance) is associated with clinically and statistically significant preservation of residual, native renal function compared to similar treatment with standard PD solution.Main Site:Waikato Primary Investigator:Dr David Voss MEC Ref:04/12/0078.Genes causing disease in Inflammatory Bowel Disease in New Zealand and development of a diet to ameliorate the disease.Main Site:AucklandPrimary Investigator:Prof Lynette FergusonMEC Ref:04/12/0119.Multicenter randomized comparative phase III trial of Onconase + Doxorubicin VS Doxorubicin in patients with malignant MesotheliomaMain Site:Wellington Primary Investigator:Dr Andrew SimpsonMEC Ref:04/12/01210.Leukaemia Research fund acute Myeloid Leukaemia and High risk MDS trial 14Main Site:Wellington Primary Investigator:Dr P Ganly MEC Ref:04/12/01311. Follow-up Serial Infusions of Natrecor (nesiritide) for Management of Patients with Heart Failure - FUSION IIMain Site:Christchurch Primary Investigator:Professor Mark Richards MEC Ref:04/12/01412. Inegrillin (eftifibatide) Injection. Early Glycoprotein IIb/IIa inhibition in Non-ST-segment a Elevation the Acute Coronary Syndrome: A Randomised, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients with Non-ST-segment Elevation Acute Coronary Syndrome Main Site:AucklandPrimary Investigator:Professor Harvey White MEC Ref:04/12/01513. Efficacy of 15 mg and 50 mg of S 18986 on cognitive symptoms inMid Cognitive Impairment patients treated over a 12-month oral administration period Main Site:Christchurch Primary Investigator:Dr Nigel Gilchrist MEC Ref:04/12/016EXTENSIONS/MODIFICATIONS/AMENDMENTS1. Exhaled nitric oxide measurements in the assessment of laboratory animal allergy.MEC Ref:04/12/009Study was approved in principle by Otago ethics committee in June 2004. Evidence of Maori consultation was pending. The researcher now wishes to extend the study into Wellington, Canterbury and Auckland.2. The European Cobalt Stent with Antiproliferativefor Trial.MEC Ref:04/12/010Amendment 2 to the Protocol revision E for consideration and approval.3. Alternative defibrillation and sensing methods for the prevention of cardiac arrest:MEC 01/12/001Request for the removal of page 5 of the information sheet and consent form.4. A multi-centre randomised, double-blind, placebo-controlled clinical trial examining the efficacy and safety of low-dose Aspirin after initial oral anticoagulation to prevent recurrent venous thromboembolism. MEC 04/12/008Request for the inclusion of posters and introductory pamphlet for recruitment.5. A randomised, double-blind, multicentre study to evaluate the toleratility and effectiveness of etoricoxib 90 mg Q.d vs Diclofenac sodium 75mg bid in patients with rheumatoid arthritis (EDGE II). MEC 03/12/001Consent addendum version 2.0 and clinical investigators brochure Ed: 11 for approval6. A long term open label randomised study in patients with type 2 diabetes, comparing the combination of Rosiglitizone with either me