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 (IITs) are established and managed by non-pharmaceutical researchers, such as clinicians and researchers working in a health institution. Most IITs are designed to support the development of new clinical practice guidelines or compare the effectiveness of existing treatments.
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, St Vincent’s Hospital Melbourne or Austin Health - the clinical members of the VCCC Alliance.
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 larger pool of patients.
The VCCC Alliance has partnered with the Melbourne Academic Centre for Health (MACH), and with assistance from the Melbourne Children's Trials Centre, to develop a suite of resources to support researchers conducting investigator-initiated trials.
Working groups, comprised of representatives from the VCCC Alliance and MACH member organisations, were created to review existing internal resources available for researchers. The working groups selected the exemplar resources available and with permission of the host institution, have made these resources available for all researchers (including non-oncology researchers) to use and/or adapt to meet the needs of their trial or institution.
These resources are supported with advisory guidance and links to relevant guidelines to provide researchers with a launching pad for conducting their research. You can link to the IIT Toolkit from the left-hand margin. You will find lots of information compiled under:
Roles and Responsibilities
Clinical Trial Life Cycle
Clinical Trials Budget
Risk Management
Data Management
Monitoring
Resources
Glossary
