Icon Cancer Foundation Sponsored Investigator Initiated Trials (IITs) Framework

Icon Cancer Foundation Sponsored Investigator Initiated Trials (IITs) Program

Icon Cancer Foundation Investigator Initiated Trials Introduction The Icon Cancer Foundation Investigator Initiated Trials (IITs) Framework outlines the requirements for IITs being conducted at Icon Group where Icon Cancer Foundation is acting as the sponsor as per Good Clinical Practice (GCP).

Icon Cancer Foundation Icon Cancer Foundation’s mission is to promote, initiate and support clinical trials and research, striving towards a brighter future for cancer patients and communities. Globally, Icon Cancer Foundation supports IITs for Icon Cancer Centre and are the sponsor for IITs managed across Icon’s international network. Icon Cancer Foundation are supported by the research team at Icon Group to develop, support and manage the IITs. For Icon IITs, the sponsor is Icon Cancer Foundation but services for administration of the IITs is given to Icon Institute of Innovation and Research (IIIR).

What we do With over 30 years experience in supporting IITs, we pride ourselves on being able to initiate, develop and manage a range of unique and varied IITs across multiple disciplines. All trials are conducted as per International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines.

The Framework The Icon IIT Framework outlines the process for IIT initiation development and ongoing management. This includes sponsor oversight for IITs, quality plan and review, site identification and feasibility, study start up activities, data management, ongoing safety reporting culminating in manuscript publication as required.

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The Team IITs are supported by the following members of Icon Group’s research and clinical trials team: Director of Research Responsible for facilitating the embedding of clinical research across Icon Group globally.

Principal Investigators (PIs) and Associate Investigators Icon has a significant number of clinicians actively involved and leading trials who are Key Opinion Leaders (KOLs) in their speciality fields.

Executive Manager Research Responsible for leading the clinical research and innovation arm of Icon Group globally with the primary goal of providing clinical trials access across Icon’s international network Investigator Initiated Trials and Grants Manager Responsible for overall project management of IITs within Icon Group globally.

Senior Operations Manager – Research Innovation and Governance Responsible for research governance, study start up, innovations and projects.

Senior Operations Manager - Research Coordination and Quality Responsible for research coordination activities at site and ensuring highest standards of research quality.

Icon Research Committees (IRCs) A group of clinical professionals with expertise in management and treatment of their specific oncology discipline or responsible for research in their state or country. The IRCs work collaboratively with the research team above to develop and review research as required.

Centralised Services IITs are supported by a range of departments within Icon Group and Icon Cancer Foundation teams.

This includes but is not limited to: •

Research Innovation and Governance

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Research Coordination and Quality

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Finance

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Statistics

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Health economics

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Pharmacy

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Nursing

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Medical physics

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Radiation therapy

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Brand and Communications

The Framework outlines the roles and responsibilities of each team to allow streamlining of processes to fast-track development and activation of clinical trials.

Icon maintains a clinical trials insurance policy for IITs. The cost for this insurance is included in all IIT budget/s.

Responsibility and Management of Icon Cancer Foundation Sponsored IITs - Quality and Sponsor Oversight Committee (QSOC) The Quality and Sponsor Oversight Committee’s (QSOC) purpose is to ensure the quality and safety of all clinical research projects and ongoing sponsor responsibilities for IITs according to GCP. Management and oversight of all Icon Cancer Foundation Sponsored research sits with the Icon QSOC which provides reports directly to the Global Research Committee (GRC) and ultimately to the Icon Board. The Icon Group Executive Manager of Research, Senior Operations Manager - Research Coordination and Quality, and Icon IIT and Grants Manager have operational responsibility for ensuring all research operational policies and procedures for Icon Cancer Foundation Sponsored trials are adhered to at all times.

The role of the QSOC is two-fold: 1. Ensure appropriate review and approval, as well as governance and risk management, in current or proposed clinical research projects where Icon Cancer Foundation is/will be the trial sponsor, as per GCP 2. Ensure all clinical research is conducted in a compliant manner and is safe and efficient according to GCP and all applicable regulatory and ethical standards, whilst protecting the rights, dignity and privacy of all research participants

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Quality is Key

Site Feasibility

Quality assurance is an integral component in the management of Icon IITs. Quality is a key theme in protocol development with a quality review conducted at a number of stages throughout protocol development. A member of the Research Quality team is involved in all aspects of protocol development.

With centres across Australia, New Zealand, Singapore, Mainland China, and Hong Kong, Icon is well-positioned to provide the required number of sites for your research project.

Icon provides all aspects of cancer care including medical oncology, haematology, radiation oncology, chemotherapy compounding, medical physics and pharmacy services, alongside specialist services across Icon’s Asia network.

Quality management continues once the clinical trial is activated.

Icon Cancer Foundation work with Icon Group’s Research Quality team to provide services for on-site and off-site monitoring and auditing of IITs.

All sites where IITs will be open to recruitment will be identified and confirmed at protocol development stage.

Icon has developed and applies a suite of Standard Operating Procedures (SOPs) via its Quality Management System, that are followed in the conduct of all IITs. Pharmacy Capabilities Icon Group provides a complete suite of management services to support the operations of Epic, Icon and Slade Pharmacies. Icon Group pharmacies provide support, innovation and management for the group’s IITs. IIT Development The IIT and Icon Research Teams work collaboratively with our partners to initiate and develop new research projects.

Defining a protocol synopsis is the initial step in development. Once the protocol synopsis is finalised, an accurate budget is developed and presented to our partners to determine the investment for the research. All IITs will have a clinical trial budget that details all costs involved in the trial, including sponsorship responsibilities.

Protocol development workshops are key to streamlining and developing the protocol in a timely manner. The aim of these workshops is to understand the project objectives, study timelines, key roles and responsibilities of team members, expected financial support and start-up of the Trial Management Committee (TMC).

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Icon will be responsible for ensuring that appropriate contracts are in place between Icon and all non-Icon sites and third-party vendors, such as any providers of external services, including pathology and imaging providers.

Icon is experienced in the following: •

Development and management of IITs where devices and drugs are not listed with the relevant competent authority and are used within the clinical trial

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Registration of a clinical trial on a relevant clinical trials registry. All Icon IITs are registered prior to any recruitment taking place

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Electronic database design and development

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Preparation and submission of HREC and governance applications

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Statistical review

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Radiation therapy quality assurance (QA)

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Health economics

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Quality of life

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Data analysis

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Manuscript preparation

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Pharmacy clinical trial management and compounding facilities

For more specific details on the process for IIT initiation, and development and management, please refer to Diagram 2.

Diagram 1: Icon IIT Governance Structure and Management

Icon Group Board

Icon Global Research Committee (GRC) Chair: Chair of global research

Icon Quality and Sponsor Oversight Committee (QSOC) Provides reports to the GRC who have no operational oversight of IITs

IIIR (Group Research Team) Provides operational management for all IITs

Trial Management Committee (TMC)

icon Research Committees Provide clinical expertise to the QSOC for IITs in their area of expertise

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Diagram 2: Study start-up flow chart for Icon Cancer Foundation Sponsored IITs Stage 1

Stage 2

PI/Funder completes

Review of proposal by

• Study IIT Proposal

• Relevant experts input

PDW

• Protocol Synopsis

• Quality 1 review

• First draft of protocol

Icon IIT & Grant Manager

• QSOC review

• Appointment of TMC

Set up and ongoing management of TMF. Project plan developed and updated regularly. Regular TMC meetings.

• CDA Executed

• Project plan

• Creation of expert KOL committee

• Identification of sites

• Budget preparation

Stage 3

Statistical review 2 Site feasibility

Protocol development (with Quality 2 review)

Independent protocol review and further revision as required

Final budget and contract approval

• Budget finalised

EC Submission Review and address queries

Submit for RGO approval

Open for recruitment

2-6 Weeks

4 Weeks

• Statistics review 1 4-6 Weeks

1 Week

2-3 Weeks

4-6 Weeks

4 Weeks

3 Weeks

Identify independent reviewers for synopsis review, provide est. timelines, identify Roles and Responsibilities.

Abbreviations • CDA Confidentiality Disclosure

Agreement • EC Ethics Committee • IIT Investigator Initiated Trial • IRC Icon Research Committee • QSOC Quality and Sponsor Oversight

Committee • RGO Research Governance Office • PDW Protocol Development

Workshop • SLA Site level agreement

1. PICF draft —>consumer review —>PICF finalised 2. Clinical trials registry registration 3. Unapproved device/drugs competent authority application (as required) 4. Insurance quotes 5. Safety reporting/monitoring/auditing/DSMB processes put in place (Icon Group’s Risk Assessment System) 6. Finalise contracts/SLA with site and external groups 7. Data management and CRF design/eCRF systems – Database development 8. Approval for QoL use 9. Approval for Health Economics use as required NOTE: Timelines are an estimate 7

iconcancerfoundation.org.au 8