Investigator-initiated trial guidance at your fingertips

Online resources, templates and guidance

Clinical investigators seeking to develop an investigator-initiated trial (IIT) now have online access to a range of information, definitions, templates and guidance collated from across VCCC alliance members and the Melbourne Academic Centre for Health (MACH) partner organisations.

Investigator-initiated trials are established and managed by non-pharmaceutical researchers, such as clinicians and researchers working in a health institution. Investigator-initiated trials benefit patients by asking important clinical questions that pharmaceutical or biotech industries are less likely to invest in. Most IITs are designed to support the development of new clinical practice guidelines or compare the effectiveness of existing treatments.

The VCCC has partnered with MACH, and with assistance from the Melbourne Children's Trials Centre, to develop guidance and collated resources to support researchers conducting investigator-initiated trials.

One-stop-shop to develop an investigator-initiated trial

The IIT toolkit provides the Victorian clinical trials sector with a one-stop-shop, from research question to protocol, conducting the trial, analysing and sharing the results. The toolkit offers clear guidance for the trial team on roles and responsibilities, and provides resources to enable adherence to regulatory requirements and best practice.

Data Management 

• Roles and responsibilities
• Collection and processing
• Storage and retention
• Data sharing

Trial Monitoring 

• Roles and responsibilities
• Trial conduct
• Safety and reporting

Risk Management 

• Roles and responsibilities
• Assessment and management
• Sponsorship definition, application and models
• Monitoring and review

An expansion of the toolkit to include additional resources is planned during the remainder of 2020. 

Victoria’s cancer clinical trial sector’s number one unmet need

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 hospitals are partners in the VCCC alliance, working together to accelerate and amplify leading-edge cancer research, knowledge and clinical care.

Backed by Victorian Government funding, the VCCC introduced the Investigator-Initiated Trials Capacity Building Program to address the number one unmet need in the cancer clinical trials field. The program provides access to resources and support mechanisms for investigators to develop cancer clinical trials.

For further information about the VCCC Investigator-Initiated Trials Capacity Building Program contact Kate Khamly, VCCC Program Manager, email [email protected].