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

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Icon Cancer Foundation Structure

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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 adam.stoneley@iconcf.org.au.