• Planning: Introduction to IITs & Developing a Protocol

• Study Start Up: Feasibility, Contracts & Budget, & Ethics & Governance

• Study Conduct: Study Coordination and Ongoing Management 

• Data Analysis: Biostatistical Analysis at every stage of a trial

• Sharing Results: Study Close Out, Results dissemination, Study Archiving

Below is a visual overview of the Investigator Initiated Trial (IIT) life cycle. This course will follow the life of an IIT over 8 educational modules. 

This course aims to enable investigators to answer new clinical questions by creating Investigator Initiated Trials which in turn increases access to clinical trials for patients.

During this course, you will have the opportunity to:

• Explore the lifecycle stages in an Investigator-Initiated Trial and the considerations for early phase Investigator-Initiated Trials 

• Explore structured guidance in developing an Investigator Initiated Trial protocol.  

• Explore essential groundwork to initiate a clinical trial, emphasising a robust feasibility assessment process through to site initiation.

• Explore contracts and common agreements that are used in the management of Investigator Initiated Trials (IITs) in Australia and considerations for budgeting for IITs. 

• Describe the preparation for ethics and governance review, the submission process, and the ongoing responsibilities of the Sponsoring Institution and participating trial sites after approval.

• Describe key activities, tasks, and responsibilities during the conduct of an Investigator Initiated Trial.

• Outline the key elements of trial data analysis including the involvement of a Biostatistician in all stages of an IIT.

• Describe the process of sharing IIT result data with the scientific community, external collaborators, and participants

By the end of the course, you will have the fundamental knowledge to follow the lifecycle of an IIT and identify key considerations when in the planning phase of an IIT. 

Note: These resources are supported with advisory guidance and links to relevant guidelines to provide researchers with a launching pad for conducting their research. 

The VCCC Alliance would like to thank the following people for their expert contribution to the course:

Dr Kortnye Smith, Medical Oncologist and Researcher, Peter MacCallum Cancer Centre and Eastern Health

Amanda Clifford, Clinical Trials Research Nurse, Peter MacCallum Cancer Centre

Duncan Colyer, Senior Manager Clinical Research, VCCC Alliance

Project Manager 

Elizabeth Diao, Project Officer - Accelerating Novel Therapies, VCCC Alliance 

The toolkit was developed by the VCCC Alliance in partnership with the Melbourne Academic Centre for Health (MACH) and with assistance from the Melbourne Children's Trials Centre. It is comprised of a suite of resources to support researchers conducting investigator-initiated trials.

These resources have now been adapted into this interactive educational course.