Download Multi – region Ethics Committee

MEETING AGENDA
Multi – region Ethics Committee
11 December 2007
VENUE:
Room 2.08
Ministry of Health
1 – 3 The Terrace
Wellington
Emalene’s DDI: 470 0655
Committee cellphone on meeting day: 027 431 8281
Members of the public may attend the meeting, which commences at 9.30 am.
Agenda for MREC meeting 11 December 2007
Page 1 of 10
Meeting of the Multi-Region Ethics Committee open to the public to be held on Tuesday
11 December 2007 at the Ministry of Health, 1 – 3 The Terrace, Wellington at 9.30am.
PRESENT:
Dr Martin Tolich (Chairperson)
Mrs Mali Erick
Dr Russell Franklin
Dr Margaret Horsburgh
Mrs Georgina Johnson
Prof Graham Mellsop
Dr Helen Moriarty
Dr Barry Smith
Mrs Carolyn Weston
Dr Sheila Williams
Ms Helen Colebrook
APOLOGIES:
Assoc Prof Cynthia Darlington
ADMINISTRATOR:
Emalene Pearson
MINUTES OF THE PREVIOUS MEETING
Confirmation of the Open Minutes of the Meeting on 20 November 2007.
Confirmation of the Closed Minutes of the Meeting on 20 November 2007.
RESUBMISSIONS
Resubmission 1: A phase IIIb, multinational, randomized, double-blind, placebocontrolled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab'
fragment of a humanized anti-TNF-alpha monoclonal antibody, administered
subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn's
disease (Study Number C87085)
Lead Investigator:
Dr Richard Gearry
Main Site:
Christchurch Hospital
MEC Ref:
MEC/07/11/158
Primary Presenter:
Graham
Secondary Presenter:
Carolyn
PIS& CF
Site
Christchurch Hospital
Waikato Hospital
Auckland City Hospital
Shakespeare Specialist Group
Wellington Hospital
Agenda for MREC meeting 11 December 2007
L/A
Y
Y
Y
Y
Y
M/C
Y
Y
Y
Part 4
Y
Y
Y
Y
Y
Page 2 of 10
Resubmission 2: A Phase IIIb, multinational open-label, follow-on trial to C87085
designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' Fragment
of a humanized anti-TNF - alpha monoclonal antibody, administered at weeks 0, 2 and 4,
and then every 4 weeks therafter, in subjects with moderately to severely active Crohn's
disease who have participated in Study C87085
Lead Investigator:
Dr Richard Gearry
Main Site:
Christchurch Hospital
MEC Ref:
MEC/07/11/160
Primary Presenter:
Graham
Secondary Presenter:
Carolyn
PIS & CF
Site
Christchurch Hospital
Waikato Hospital
Auckland Hospital
Shakespeare Specialist Group
Wellington Hospital
L/A
Y
Y
Y
Y
Y
M/C
Y
Y
Y
Part 4
Y
Y
Y
Y
Y
Resubmission 3: Children's Oncology Group (COG) AAML0531 A Phase III
Randomized Trial of Gemtuzumab Ozogamicin (Mylotorg) combined with Conventional
Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents,
and Young Adults
Lead Investigator:
Dr Nyree Cole
Main Site:
Starship Children’s Health
MEC Ref:
MEC/07/11/147
Primary Presenter:
Russell
Secondary Presenter:
Margaret
PIS for patients aged 7 – 15
PIS&CF for patients older than 16
PIS&CF for parents/guardians/caregivers
Site
Starship Children’s Health
Wellington Hospital
Christchurch Hospital
L/A
Y
M/C
Part 4
Y
Resubmission 4: A Phase 1 Randomized, Blinded, Placebo Controlled, safety and
Pharmacodynamic Study of BHT-3021 with Open Label Cross-Over in Subjects with
Type I Diabetes Mellitus
Lead Investigator:
Dr John Baker
Main Site:
CCREP, Middlemore Hospital
MEC Ref:
MEC/07/12/177
Primary Presenter:
Secondary Presenter:
Margaret
Form B
Part 5
Part 6
Agenda for MREC meeting 11 December 2007
Page 3 of 10
PIS&CF for main study
PIS for urine collection
PIS for fasting
Site
Middlemore Hospital
Christchurch Hospital
Waikato Hospital
Wellington Hospital
L/A
Y
Y
Y
M/C
Part 4
Y
Y
Y
NEW PROTOCOLS
1.
Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa - Carbidopa
Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease
and Severe Motor -Fluctuations. Protocol Number: S187.3.004. Protocol Date:
Amendment 01 dated 16 July 2007
Lead Investigator:
Prof Tim Anderson
Main Site:
Van der Veer Institute, Christchurch
MEC Ref:
MEC/07/12/166
Primary Presenter:
Russell
Secondary Presenter:
Helen C
Protocol S187.3.004 amendment 01 dd 16/7/2007
Investigator’s Brochure IB-187.02 dated 14/9/2007
Form B
Part 5
Generic PIS&CF from sponsor’s master version
Site
L/A
M/C
Part 4
Christchurch
Y
Y
Y
Wellington
Y
Waikato
Y
Y
Y
2.
A Phase 1 randomized, prospecive, double-masked, vehicle-controlled, dose-escalation
study to evaluate the safety, tolerability and clinical effect of Nexagon in participants
following bilateral photorefractive keratectomy (PRK) for the correction of mild to
moderate myopia
Lead Investigator:
Dr Sue Ormonde
Main Site:
Auckland Eye
MEC Ref:
MEC/07/12/167
Primary Presenter:
Helen M
Secondary Presenter:
Georgina
Form B
Protocol NEX-OCU-001
Investigator’s Brochure for NEXAGON™
Site
L/A
M/C
Part 4
Auckland Eye
Y
Y
Wellington Eye Center Ltd
Y
Y
Agenda for MREC meeting 11 December 2007
Page 4 of 10
3.
An Open-Label, Phase IIIb, Multi-centre, Randomised, Parallel-Group Study to
Investigate the Efficacy and Safety of Three Dosing schedules of Subcutaneous
Dynepo in Adult Patients with anaemia Associated with Chronic Kidney Disease who
are Pre-Dialysis or Require Peritoneal Dialysis or Haemodialysis
Lead Investigator:
Dr John Schollum
Main Site:
Dunedin Hospital
MEC Ref:
MEC/07/12/168
Primary Presenter:
Graham
Secondary Presenter:
Barry
Form B
Protocol SPD490-301
IB for Epoetin Delta (Dynepo®)
PIS&CF EU Master V4, NZ v3 dd 21/11/2007
Site
L/A
M/C
Part 4
Dunedin Hospital
Y
Y
Middlemore Hospital
Auckland city Hospital
4.
A multi-centre, double-blind, parallel group, phase IIa clinical trial to assess the
efficacy and safety of Cpn10 administered as twice weekly subcutaneous injections in
subjects with rheumatoid arthritis
Lead Investigator:
Dr Nigel Gilchrist
Main Site:
CGM Research Trust, Christchurch
MEC Ref:
MEC/07/12/169
Primary Presenter:
Russell
Secondary Presenter:
Helen C
Form B
Protocol CBIO2007-01
IB for Cpn10
Generic PIS&CF for main study version 1 dated 9/11/2007
PIS&CF for pharmacodynamic substudy for Dr Gilchrist only
PIS&CF for pharmacokinetic substudy for Dr Gilchrist only
Part 5
6 participant questionnaires
Site
L/A
M/C
Part 4
CGM Research Trust, Christchurch
Y
Y
Middlemore Hospital
Y
Y
QE Health, Rotorua
Waikato Hospital
Wellington Regional Rheumatology Unit
Y
5.
A multicentre, randomized, double-blind, non-inferiority study comparing the
efficacy and safety of once-weekly subcutaneous biotinylated idraparinux (SSR
126517E) with oral adjusted-dose warfarin in the prevention of stroke and systemic
thromboembolic events in patients with atrial fibrillation
Lead Investigator:
Prof Harvey White
Main Site:
Auckland City Hospital
MEC Ref:
MEC/07/12/170
Primary Presenter:
Helen M
Agenda for MREC meeting 11 December 2007
Page 5 of 10
Secondary Presenter:
Form B
Protocol EFC10295 version 2.0
IB SSR126517, edition 3
IB SSR126517, edition 5
Part 5
Site
Auckland City Hospital
Whangarei Hospital
Christchurch Hospital
Dunedin Hospital
Georgina
L/A
M/C
Part 4
Y
6.
A Phase III, Randomised, double-blind, Dose-Response, Stratified, PlaceboControlled Study Evaluating the Safety and Efficacy of SPD476 versus Placebo over
104 weeks in the Prevention of Recurrence of Diverticulitis.
Lead Investigator:
Dr Alison Ross
Main Site:
CURT Medical Trials Trust Inc
MEC Ref:
MEC/07/12/171
Primary Presenter:
Graham
Secondary Presenter:
Barry
Form B
Protocol
Investigator’s Brochure
PIS&CF for Christchurch site
Part 5
Insurance Certificate until 31/7/2009
Health questionnaires
Site
L/A
M/C
Part 4
CURT Medical Trials Trust Inc,
By Ethcomm
Y
Christchurch
Shakespeare Specialist Group
By Ethcomm
Tauranga Hospital
Auckland City Hospital
7.
A randomised, double-blind, placebo controlled, Bayesian adaptive dose finding study
to investigate the safety, tolerability, pharmacokinetics and pharmodynamics of single
and repeat intravenous infusions of GSK315234A in patients with active rheumatoid
arthritis.
Lead Investigator:
Dr Alan Doube
Main Site:
Waikato Hospital
MEC Ref:
MEC/07/12/172
Primary Presenter:
Russell
Secondary Presenter:
Mali
Form B
Protocol
IB
P4 Waikato / Christchurch
Loc Waikato
PI Consent forms Waikato
Agenda for MREC meeting 11 December 2007
Page 6 of 10
Questionnaires
Site
Waikato
Christchurch
Hutt Valley
L/A
Y
M/C
Part 4
Y
Y
8.
A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group,
Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability,
and Efficacy of a Single Dose of Intravenous MK 0157 for the Prevention of
Chemotherapy-Induced Nausea and Vomiting (CINV) Associated with Cisplatin
Chemotherapy
Lead Investigator:
Dr David Gibbs
Main Site:
Christchurch
MEC Ref:
MEC/07/12/173
Primary Presenter:
Helen M
Secondary Presenter:
Sheila
Protocol
Form B
Investigator’s Brochure
PIS&CF for Christchurch site
Part 5
Insurance Cert
Letter of Application for Scott
Patient Diary
Study Flow Chart
Site
L/A
M/C
Part 4
Christchurch Hospital
Y
Wellington Hospital
Hamilton Hosptial
9.
The Medtronic Branch Clinical Trial - A prospective, multi-centre, non-randomised,
single arm trial to assess the feasibility and safety of the Medtronic Bifurcation Stent
System for Bifurcation Lesions
Lead Investigator:
Dr John Ormiston
Main Site:
Auckland City Hospital
MEC Ref:
MEC/07/12/174
Primary Presenter:
Graham
Secondary Presenter: Carolyn
Protocol
Investigator Brochure
Part 5
Form B
PIS & CF Version 2 dated 29 November 2007
Bifurcation Stent System - Instructions for use
Wire Placement Catheter - Instructions for use
Letter re: radiation dosage
Agenda for MREC meeting 11 December 2007
Page 7 of 10
Sponsor declaration
Insurance Cert
Site
Auckland City Hospital
Mercy Hospital
Dunedin Hospital
L/A
Y
Y
M/C
Part 4
Y
Y
10. A sense of the possible through the view finder: The hopes of patients with terminal
cancer and the optimistic expectations or hopes of clinicians within the culture of
palliative care.
Lead Investigator:
Kate Richardson
Main Site:
University of Auckland School of Nursing
MEC Ref:
MEC/07/12/175
Primary Presenter:
Margaret
Secondary Presenter:
Mali
Form A
Study design
PIS for patients and for clinicians
CF for patients and for clinicians
Site
L/A
M/C
Part 4
University of Auckland
Y
Dunedin Public Hospital
Wakefield Hospital, Wellington
11. The Australian and New Zealand MS Genetics Project (ANZ gene)
Lead Investigator:
Associate Professor Bruce Taylor
Main Site:
MS Research Centre Christchurch
MEC Ref:
MEC/07/12/176
Primary Presenter:
Barry
Secondary Presenter: Sheila
CF & PIS
Part 5 & 6
Site
Christchurch
Auckland City Hospital
L/A
M/C
Part 4
Y
Y
12.A Phase 1 Randomized, Blinded, Placebo Controlled, safety and Pharmacodynamic
Study of BHT-3021 with Open Label Cross-Over in Subjects with Type I Diabetes
Mellitus – see resubmission 4
13 An Open-label follow up trial of telmisartan 40mg+ amlodipine 10mg or telmisartan
80mg- amlodipine 10mg tablets alone or with other antihypertensive medications in
patients with hypertension. Study Number 1235.8
Lead Investigator:
John Gillies
Main Site:
Tauranga
MEC Ref:
MEC/07/12/178
Agenda for MREC meeting 11 December 2007
Page 8 of 10
Primary Presenter:
Russell
Secondary Presenter:
Margaret
Protocol
Part 5
Generic PIS & CF
Patient Identification Card
Insurance Cert
Site
Tauranga
Middlemore Hospital
Caversham Medical Centre
L/A
Y
Y
M/C
Part 4
Y
Y
14. Phase IV randomized, Observer-Blind, Placebo Controlled, Mulit-Centre Study to
Evaluate the Efficacy, Safety and Tolerability of CSL Limited’s Influenza Virus Vaccine
in Adults Aged >18 to >65
Lead Investigator:
Dr Rob Ellis-Pegler
Main Site:
Auckland Clinical Studies Limited
MEC Ref:
MEC/07/12/179
Primary Presenter:
Helen M
Secondary Presenter:
Sheila
Protocol
Product Information
Part 5
Form B
PIS & CF – Auckland, Youth Health, Christchurch South & Caversham
Patient 5 Day Diary
Patient 21 Day Diary
Site
L/A
M/C
Part 4
Auckland Clinical Studies
Y
Y
Youth Health Centre
Y
Y
Christchurch South Health Centre
Y
Y
Caversham Medical Centre
Y
Y
Y
15. Long Term Administration of Inhaled Dry Powder Mannitol (IDPM) In Cystic
Fibrosis – A Safety and Efficacy Study
Lead Investigator:
Dr John Kolbe
Main Site:
Greenlane Clinical Centre
MEC Ref:
MEC/07/12/180
Primary Presenter:
Graham
Secondary Presenter:
Margaret
Protocol
Part 5
Form B
Insurance Cert
PIS & C F - Otago
PIS &CF - Auckland
Site
L/A
M/C
Part 4
Greenlane Clinical Centre
Y
Y
Agenda for MREC meeting 11 December 2007
Page 9 of 10
Dunedin Hospital
AMENDMENTS
1. An eight-week randomised, 3-arm, double-blind study to compare the safety and
efficacy of the combination of telmisartan 40mg +amlodipine 10mg versus telmisartan
80mg + amlodipine 10mg versus amlodipine 10mg monotherapy in patients with
hypertension who fail to respond adequately to treatment with amlodipine 10mg
monotherapy
MEC/07/08/109, Lead Investigator: Dr John Gillies Lead Site: P3 Tauranga
 Clarification of Guidelines for reporting of Serious Adverse Events
2. COG AOST0331: A randomized trial of the European and American Osteosarcoma
study group to optimize treatment strategies for resectable osteosarcoma based on
histological response to pre-operative chemotherapy
MEC/06/09/104, Lead Investigator: Dr Ruellyn Cockcroft, Lead Site: Starship Hospital
Lead Reviewer - Chris
 COG list of amendments – Therapy and Informed Consent Changes
 NIH letter of approval of amendment #2
 Highlighted protocol AOST 331 Amendment #2 dated 21 September 2007
3. Neuroblastoma biology studies and banking of samples. ANBL00B1. Substudy of
children's cancer group therapeutic neuroblastoma trials
AKL/2000/270, Lead Investigator: Dr Lochie Teague, Lead Site – Starship Hospital


COG Amended Protocol Version #7, 6th August 2007 –Eligibility Changes
Information Sheets and Consent Forms
4. Cardiac inherited disease registry', familial hypertropic cardiomyopathy registry,
familial dilated cardiomyopathy registry, long QT syndrome registrar
AKX/02/00/10, Lead Investigator: Dr John French, Lead Site: Auckland Hospital

Five year review of old study
GENERAL BUSINESS
1.
Schedule 1:
Schedule 2:
Schedule 3:
Schedule 4:
2.
Claim forms
Amendments reviewed by the Chairperson
Amendments reviewed by the Deputy-Chairperson
SAEs reviewed by the Deputy-Chairperson
Studies approved by the Multi-region Ethics Committee since the last
Meeting
Agenda for MREC meeting 11 December 2007
Page 10 of 10