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The Genomic Cancer Clinical Trial Initiative – collaboration toward achieving common goals (#73)

Paul Jackson 1 , Cleola Anderiesz 1 , Christine Giles 1 , Helen Zorbas 1
  1. Cancer Australia, Surry Hills, NSW, Australia

Aims

In 2013, Cancer Australia, established a Genomic Cancer Clinical Trial Initiative. This innovative initiative aims to support collaborative development of mutation-specific cancer clinical trial concepts by Australia’s national Cooperative Trials Groups (CTGs), to provide the evidence for efficacy of targeted cancer treatments.

Increases in understanding of the specific genetic changes contributing to different cancers and development of chemotherapeutic agents which target particular cancer mutations, is facilitating personalised medicine through targeted therapies. 

Clinical trials into effectiveness of novel, targeted therapies, in small patient populations, will require collaborative trial development and research which crosses traditional boundaries of trials undertaken by existing trial groups in Australia.

Methods

The Genomic Cancer Clinical Trial Initiative is supporting development of mutation-specific clinical trial concepts through a strategy which involves all CTGs and other relevant stakeholders across Australia. The development of mutation-specific clinical trials is being achieved by conducting workshops with CTGs and key stakeholders to identify potential targets for the development of mutation-specific cancer clinical trial concepts, undertaking literature reviews, reviews of international mutation-specific cancer clinical trials protocols, peer review of protocols, statistical design and sample size calculations to assist in development of trial protocols, and supporting the development of applications for competitive funding of trials.

Results

In its first two years of operation, concepts addressing optimisation of chemotherapy for small cell carcinomas, and effectiveness of drugs targeting HR-negative breast and ovarian cancers, have been submitted for competitive funding, and over 15 novel collaborative trial concepts from CTG members have been reviewed. In addition, the Genomic Cancer Clinical Trial Initiative has conducted three major workshops involving key stakeholders.

Conclusions

The Genomic Cancer Clinical Trial Initiative is an innovative and effective mechanism for the collaborative development of targeted clinical trial concepts.

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