Investigator-Initiated Trials

Resources to assist investigators to open and conduct clinical trials, as well as increase the number of investigator-initiated trials implemented.

Support mechanisms provide a coordinated approach

The VCCC cancer research community determined a lack of capacity for investigator-initiated trials as their most frequently identified unmet need.

The VCCC Investigator-Initiated Trial Capacity Building Program provides access to:

• Knowledge Bank: advice and coaching for investigators to develop novel trials concepts through to the development of clinical trial protocols.
• Trial Assistance Scheme: trial management, site management and biostatistical support for selected projects that are judged by an independent review panel to have the greatest potential to impact clinical care.

The program is being rolled out in stages to allow for support mechanism assessment.

Stage 1: Enhancing a fully-funded concept (closed)

Stage 2a: Idea generation to protocol development (closed)

Stage 2b: VCCC Knowledge Bank and Trials Assistance Scheme (closed)

Stage 2c: Expert support and capability build (closed)

Increasing trial capacity across Victoria

Clinical trials are commonly led by pharmaceutical and biotechnical organisations, overseen by a panel of experts and implemented through clinical trial units. Investigator-initiated trials are established and managed by non-pharmaceutical researchers, such as clinicians and researchers working in a health institution.

The Investigator-Initiated Trial Capacity Building Program aims to facilitate:

• High-quality investigator-initiated clinical trials conducted in Victoria
• An increased number of Victorian cancer patients enrolled in clinical trials
• Improved quality and increased quantity of evidence for practice change
• An increased number of experienced clinical trial investigators
• Development of high-quality, consistent start-up processes for investigator-initiated clinical trials
• Promotion of consistent data collection for non-commercial trials

Effective use of existing structures and governance

In Victoria, 70 per cent of all cancer clinical trials are conducted at either Western Health, the Royal Children’s Hospital, the Royal Women’s Hospital, Peter MacCallum Cancer Centre, the St Vincent’s Hospital or Austin Health - the clinical members of the VCCC.

These institutions provide a critical mass of successful clinical trial facilities and clinician researchers, with proven infrastructure and reinforced governance methods. The investigator-initiated trials approach benefits from the facilities’ knowledge and resources; providing a greater variety of trials to a greater pool of patients.

Contact for further information

Got a question? Check out the frequently asked questions page first.

For further information regarding the program and application support, contact Kate Khamly, Program Manager, phone 03 8559 8872.