Investigator-initiated trials broaden opportunities and benefits to patients


  • 31 Jul 2018

Pictured: Professor Geoff Lindeman, credit: Walter and Eliza Hall Institute.

The Victorian Comprehensive Cancer Centre’s first Investigator-Initiated Trial Capacity Building support package has been awarded to Professor Geoff Lindeman, clinician scientist at the Walter and Eliza Hall Institute, Royal Melbourne Hospital, Peter MacCallum Cancer Centre and The University of Melbourne.

Professor Lindeman’s trial aims to evaluate the effects of adding a new anti-cancer drug to the current gold standard therapy used to treat estrogen receptor (ER) positive metastatic breast cancer, the most common type of breast cancer.

Victorian Comprehensive Cancer Centre (VCCC) Executive Director, Professor Grant McArthur said, “The VCCC is delighted to support Professor Lindeman’s breast cancer trial. The trial has great potential to transition into a clinical setting and it is an excellent opportunity to explore the impact of a new anti-cancer drug on certain breast cancers through an investigator-initiated trial.”

Investigator-initiated trials benefit patients by asking questions that pharmaceutical or biotech industries are unlikely to invest in.

Professor Lindeman said, “The VCCC’s clinical trials programs are innovative in providing benefits on a number of levels. Investigator-initiated trials allow the research and clinical community to extend and explore new ideas.

"The approach also provides patients with access to a greater variety of trials open to a larger pool of participants.”

Victoria’s health and research delivers successful trials through established structures

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.

Investigator-initiated trials are established and managed by non-pharmaceutical researchers, who also retain responsibility for legal and regulatory requirements. VCCC alliance partners provide a critical mass of successful clinical trial facilities and clinician researchers, with proven infrastructure and established governance methods.

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. Professor Grant McArthur said, “This new program provides access to resources to support development, application and management of selected trials and will also teach us how to generate and assist more of these trials in future. This is a key strategic priority for the VCCC and will enhance the overall clinical trials capacity across our alliance and across Victoria.”

Support mechanisms provide a coordinated approach

The VCCC Investigator-Initiated Trials Capacity Building program is being rolled out in stages to allow for a robust assessment of the support mechanisms. This first Investigator-Initiated Trials Capacity Building support package has been launched with the intention to enhance a partially-funded concept; led by an investigator with a track record.

Professor Lindeman’s trial will be provided with access to statistical support from Murdoch Children’s Research Institute (MCRI) and the University of Melbourne, clinical trial management services through the Peter MacCallum Cancer Centre, Centre for Biostatistics and Clinical Trials (BACT) and site management services through Cancer Trials Australia (CTA).

Cancer Trials Australia CEO Dr Kurt Lackovic said, “We are excited to be a part of this important program; helping to remove barriers by coordinating agreements, developing budgets and ethics submissions, as well as aiding reporting processes, to ensure more Victorian patients benefit from our cutting-edge research sooner.”

Stage 2 of the program will provide support throughout the breadth of the clinical trial process, from idea generation to protocol development, and grant application.

Expressions of interest for Stage 2 of the VCCC Investigator-Initiated Trials Capacity Building program opens in August, an overview is available on the VCCC website.