The Victorian Comprehensive Cancer Centre

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Investigator-Initiated Trials

The VCCC’s Investigator-Initiated Trial Capacity Building program has been established to address the number one unmet need in the cancer clinical trials field.

Effective use of existing structures and governance

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

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

These health 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.

Increasing trial capacity across Victoria

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

The Investigator-Initiated Trial Capacity Building program provides resources to help more investigators to open and conduct clinical trials, as well as increase the number of investigator-initiated trials conducted.

The program goals are to facilitate:

  • More high-quality investigator-initiated clinical trials.
  • Greater number of cancer patients enrolled in clinical trials.
  • Improve quality and increase quantity of evidence for practice change.
  • Expanded numbers of experienced clinical trial investigators.
  • High-quality, consistent start-up processes for investigator-initiated clinical trials.
  • Consistent collection of data for non-commercial trials.

Support mechanisms provide a coordinated approach

The program provides access to:

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

The VCCC Investigator-Initiated Trial Capacity Building program is being rolled out in stages to allow for assessment of the support mechanisms.

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

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

Stage 2b: OPEN, access the Knowledge Bank and Trial Assistance Scheme

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