Investigator-initiated trials broaden opportunities and benefits to patients

July 31, 2018 Lucy Dalton

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.

The forthcoming 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.”

Professor Geoff Lineman. Image credit: Walter and Eliza Hall Institute

Investigator-initiated trials benefit patients by asking important clinical questions that pharmaceutical or biotech industries are less likely to invest in. Professor Lindeman said, “The VCCC’s clinical trials programs are innovative at a number of levels and provide direct benefit to patients with cancer. Investigator-initiated trials allow the laboratory and clinical researchers to extend and explore new ideas. They also provide patients with early access to promising drugs.”

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.

For more information about Investigator-Initiated Trial Capacity Building

For further information regarding the Investigator-Initiated Trial Capacity Building program, contact Kate Khamly, Program Manager via email kate.khamly@unimelb.edu.au or call on 03 8559 8872.

Article source: Victorian Comprehensive Cancer Centre

Events, News

Translating biomedical research: Lessons from Boston, Tel-Aviv and our own backyard

July 24, 2018 Lucy Dalton

Overview of our July Collaborate + Connect + Commercialise networking event.

More than 150 people attended our third networking event which showcased a panel discussion on the opportunities and challenges facing scientists in the quest for commercialisation and the translation of research into patient care.

Dr Sky Gross was joined by Dr Andrew Nash, Senior Vice President Research for CSL, Nathan Elia from the Victorian Government’s Trade and Investment Office in Boston, Professor Aleksandar Subic – Deputy Vice-chancellor (Research & Development), Swinburne University for a robust discussion and reflection on the topic.

One of the most common themes emerging from the panel discussion was about building a culture that supports a commercial approach and also early engagement – undertaking research that has potential for commercial success and therefore faster translation into patient care.

Sky Gross identified that there is a lot to be said for just ‘having a go’.

“In Israel, we have a culture of making the most of what we have, therefore people are really motivated to try new things in business,” she said. “They will set up a start-up in the biomedical field and not feel discouraged if they fail. They know they can get up and try again,” she said.

“In Australia in the biomedical sectors it’s clear there is not a big pool of people who have experience in start-ups, so we need to work out how we can share what knowledge we have to encourage people to think differently about their work.”

Professor Aleksandar Subic from Swinburne University recognised that developing an innovation ecosystem and embedding a culture of innovation and commercial thinking was critical to success, as is a network that supports this culture.

“For us innovation is in every department, Faculty and Institute, as is a culture of commercial thinking. The best research leads to best impact. Commercialisation is often the missing piece in our scoping and support. We need to establish an ecosystem that supports our teams to achieve their full potential for research translation and commercialisation based on timely expert support.”

Nathan Elia, agreed, “thinking more about impact, rather than just publication is imperative.”

Dr Andrew Nash from CSL echoed this, identifying the need for a clear pathway for teams of scientists keen to understand the commercial opportunities.

“Not all research needs, or will have, a commercial imperative. But if it does, then scientists need to know what they have to do, what’s the path they can take to get commercial value from their work. We have no shortage of quality scientists in Melbourne, the skill is to support and work with them to make the most of their work in every way. ”

These events continue to bring together industry and the sector to help build further impact for the Precinct.