Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
Site Brochure for Sponsors and Collaborators
14 September 2017
Site Brochure, 14 September 2017 Page 2 of 12
Icon Cancer Foundation
Information for Clinical Research Associates and Monitors
These guidelines have been written to assist the Clinical Research Associates (CRA), the Clinical Trial Coordinators (CTC) and Data Managers (DM) in monitoring oncology and haematology research being conducted at Icon Cancer Foundation.
ICON CANCER FOUNDATION & ICON CANCER CARE 3 Icon Cancer Care Organisational Structure 3 Icon Group Sites 5 Icon Cancer Foundation Structure 6
ICON CANCER FOUNDATION RESEARCH PORTFOLIO 7 Trial Recruitment by Indication Error! Bookmark not defined. Number of Active Studies by Sponsorship Error! Bookmark not defined. Number of Active Studies by Phase Error! Bookmark not defined.
BENEFITS OF CONDUCTING RESEARCH AT ICON CANCER FOUNDATION STAFF 10 Site Maintenance Organisation Structure Error! Bookmark not defined. Ethical Review of Research Opportunities 10 Research Governance Review 11 Additional Information 12
Site Brochure, 14 September 2017 Page 3 of 12
Icon Cancer Foundation, Icon Cancer Care and ROC
The Haematology and Oncology Clinics of Australia Research Centre trades as Icon Cancer Foundation
and is a registered, not-for-profit charity that facilitates the conduct, management and coordination
of multi-centre national and international clinical research studies together with our research
partners.
Icon Cancer Foundation works in close collaboration with Icon Cancer Care and Radiation Oncology
Centres (ROC), which are the largest private provider of cancer and haematological services in
Australia. Icon Cancer Care and Radiation Oncology Centres are separate for-profit legal entities to the
Foundation and combine to form a network of over 100 medical specialists, of which over 40 are
actively participating as principal or co-investigators in clinical trials and other research projects. These
medical specialists are Visiting Medical Officers of Icon Cancer Care and Radiation Oncology Centres
with expertise in the management of oncology and haematology.
Icon Cancer Foundation recruits its clinical research participants from Icon Cancer Care and
Radiation Oncology Centres and have considerable experience in the conduct of cancer clinical trials
and other research projects and is committed to conduct research in accordance with a regulatory
framework. This site operates in accordance with the Guidelines for the International Conference on
Harmonization, Guidelines for Good Clinical Practice as adopted by the Therapeutic Goods
Administration and the National Statement in Research Involving Human Subjects.
For an overview of the history, structure, staff and research portfolio of Icon Cancer Foundation
please refer to the current version of Icon Cancer Foundation Site Brochure available upon request
or online at www.iconcancerfoundation.org.au .
Overview of Roles within Icon Cancer Foundation
The Clinical Trial Operations Manager, the Trial Coordinator Team Lead, the Data Manager Team
Lead and Clinical Research Start-Up Specialist of the Foundation are the primary contacts
responsible for studies in the site selection and feasibility stages. All studies undergo an internal
review process and must be presented to the Icon Cancer Foundation Research Committee every
two months for approval.
Once activated the Principal Investigator oversees and delegates the coordination of patient
assessments, monitoring of clinical activities and collection of source data to the Clinical Trial
Coordinator with the Data Manager at Icon Cancer Foundation responsible for the day to day data
management and essential document management for the study.
Site Brochure, 14 September 2017 Page 4 of 12
Icon Cancer Care Organisational Structure
Integrated Clinical Oncology Network Pty Ltd
trading as Icon Cancer Care or
Radiaton Oncology Centres
Icon Cancer Care Auchenflower
Icon Cancer Care Chermside
Icon Cancer Care South Brisbane
Icon Cancer Care Southport
Icon Cancer Care Townsville
Radiation Oncology Centres Cairns
Radiation Oncology Centres Gold Coast
Radiation Oncology Centres Toowoomba
Visiting Medical Officers
(Oncologists and Haematologists)
Haematology and Oncology Clinics of Australia
Research Centre trading as
Icon Cancer Foundation
Site Brochure, 14 September 2017 Page 5 of 12
Icon Group Sites
Site Brochure, 14 September 2017 Page 6 of 12
Icon Cancer Foundation Structure
Site Brochure, 14 September 2017 Page 7 of 12
Icon Cancer Foundation Research Portfolio
Icon Cancer Care and Radiation Oncology Centres Accrual by Indication
(01-Jan-2017 to 31-Aug-2017)
Breast Cancer , 11
Genitourinary Cancer, 5
Gynaecological Cancer, 14
Head & Neck Cancer, 3
Leukaemia, 3Lung Cancer, 15
Myeloma, 1Other Haematology, 1
Prostate Cancer, 24
Colorectal Cancer, 1
Site Brochure, 14 September 2017 Page 8 of 12
Icon Cancer Care and Radiation Oncology Centres Accrual by Indication
(01-Jan-2017 to 31-Aug-2017)
0
2
4
6
8
10
12
14
16
Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17
ICC Auchenflower ICC Chermside ICC Gold Coast ICC South Brisbane ROC Cairns ROC Gold Coast ROC Toowoomba
Site Brochure, 14 September 2017 Page 9 of 12
Icon Cancer Care and Radiation Oncology Centres Accrual by Sponsorship
(01-Jan-2017 to 31-Aug-2017)
Icon Cancer Care and Radiation Oncology Centres Accrual by Phase
(01-Jan-2017 to 31-Aug-2017)
32
63
1423
0
5
10
15
20
25
30
35
Pharmaceutical Collaborative Investigator
Icon ROC
1
11
27
2
23
14
0
5
10
15
20
25
30
35
40
45
I II III IV
Icon ROC
Site Brochure, 14 September 2017 Page 10 of 12
Benefits of Conducting Research at Icon Cancer Foundation
Icon Cancer Foundation operates research activities across multiple day hospitals, staffed by research
investigators and trial coordinators with an infrastructure of regulatory management, administrative,
financial supervision and data management support from the head office. This structure allows a core
strength of stability with flexibility to grow and utilise resources and expertise at our clinic sites. Icon
Cancer Foundation works in conjunction with Radiation Oncology Centres, enabling a combination of
radiotherapy/medical oncology research, and increasing research access for the patient population. As
a result of this model of service delivery Icon Cancer Foundation has been required to develop site
operating procedures and study oversight plans to ensure that the standard of research activity and
investigator oversight is compliant with both the Integrated Addendum to the International Council for
Harmonisation Guidelines for Good Clinical Practice (ICH GCP E6 (R2)) and the National Statement on
Ethical Conduct in Human Research 2007.
Ethical Review of Research Opportunities
Once the Icon Cancer Foundation Research Committee approves a study to be conducted at Icon
Cancer Care sites, and the Sponsor has forwarded a site-selection confirmation, Icon Cancer
Foundation staff will prepare and coordinate the submission of the initial ethics application to the
relevant Human Research Ethics Committee (HREC). If chosen as a lead site for a multiple centre study
or for single site studies, Icon Cancer Foundation utilises the services of one of three independent
HRECs.
Bellberry Human Research Ethics Committee - All day hospitals
Mater Health Services (MHS) Human Research Ethics Committee - Icon Cancer Care South Brisbane (inpatient treatment)
Uniting Care Health (UCH) Human Research Ethics Committee - Icon Cancer Care Wesley (inpatient treatment)
The choice of HREC is determined by study requirements for inpatient hospitalisation and the use of
either the Mater Private Hospital or the Wesley Private Hospital. The average time of research
activation from site selection as determined by the confirmation of site selection to site activation as
determined by the conduct of the site initiation visit is 100 days with HREC submission to approval on
average taking less than 30 days.
Site Brochure, 14 September 2017 Page 11 of 12
Research Governance Review
Icon Cancer Foundation has implemented a streamlined process to ensure that research undertaken
under Icon Cancer Foundation auspices are both designed and conducted in accordance with the
Australian Code for the Responsible Conduct of Research and ethically reviewed and monitored in
accordance with the NHMRC National Statement. As Icon Cancer Foundation does not operate within
the public health care sector there is no requirement to conduct the site specific assessment processes
typically required in the public hospital environment and Icon Cancer Foundation is well suited to
provide expedient but thorough research governance review without unnecessary delays and no
additional charge to the sponsor above the ethics committee review fees and institutional start-up
costs.
Fostering Patient Access to Clinical Research
Icon Cancer Foundation is both a stakeholder and member of the steering committee for the COSA
Australasian Tele-trial Model and is well positioned to assist in the support of not only the Tele-trials
model but also the remote delivery of clinical trial opportunities via Icon Cancer Foundation across the
Icon Cancer Care and Radiation Oncology Centres network of sites. Icon Cancer Foundation and its
research activities have evolved a spoke-hub distribution of services where the clinical research
activities of Icon Cancer Care and Radiation Oncology clinical sites are supported and coordinated from
the hub at the South Brisbane office of Icon Cancer Foundation.
Icon Cancer Foundation Spoke-Hub Service Model
Icon Auchenflower Patients
Investigators
Trial Coordinators
Icon Chermside Patients
Investigators
Trial Coordinators
ROC Toowoomba Patients
Investigators
Trial Coordinators
Icon South Brisbane
Patients
Investigators
Trial Coordinators
Icon Cancer Foundation Start-Up / Ethics
Data Management
Finance Management
Oversight
ROC Cairns Patients
Investigators
Trial Coordinators
Icon Southport
Patients
Investigators
Trial Coordinators
Icon Townsville Patients
Investigators
Trial Coordinators
ROC Gold Coast Patients
Investigators
Trial Coordinators
Site Brochure, 14 September 2017 Page 12 of 12
Advantages that the Icon Cancer and Radiation Oncology Centres have include:
Direct access to patients close to their community
Coverage from far north Queensland to coastal and rural south east Queensland
Specialized facilities with cutting edge technologies
Passionate clinicians with an imbedded culture of research
Specific features that ICF provides at the South Brisbane office includes the following:
Coordination of new study protocol review by the investigator group
Completion of feasibility assessment for new study protocols
Evaluation of the research proposal at the ICF Research Committee
Collection and maintenance of essential documents
Facilitation of ethical and research governance approvals
Research budget assessment and single contract negotiation
Entry and oversight of the protocol on the Clinical Trial Management System (CTMS)
Centralized and timely data management and query resolution services
Financial management and revenue recovery for the protocol
Advice for support of investigator-driven research opportunities
Use of Third Party Vendors
As a private organisation, Icon Cancer Foundation is not hindered by internal resources and utilises the
services of third party vendors and other agencies as required to meet protocol mandated
requirements. Quality of services from the third party vendors is guaranteed under a series of service
agreement instituted as a result of Icon Cancer Foundation’s adherence with the Integrated
Addendum to the International Council for Harmonisation Guidelines for Good Clinical Practice (ICH
GCP E6 (R2)).
Additional Information
Further detail regarding the research capacity of Icon Cancer Foundation, the start-up processes, the
schedule of research fees, the capacity to undertake early phase trials and the study oversight plans
for research undertaken at Icon Cancer Foundation is presented in the following documents available
upon request:
Icon Cancer Foundation Pre-Study Manual
Icon Cancer Foundation Study Conduct Manual
Please feel free to contact the Clinical Trial Operations Manager, Adam Stoneley on +61 7 3737 4558
or via [email protected].