Australia is the destination of choice for commercially sponsored clinical trials because of the international standing of its investigators, its vibrant world-class basic science community and its infrastructure that efficiently translates new discoveries into viable treatments for intractable diseases.
‘Our reputation in medical research is backed by first rate publications and our performance in clinical trials is guided by Good Clinical Practice,’ said Dr Tina Soulis, General Manager of Neuroscience Trials Australia. ‘This means clinical trials conducted in Australia are recognised for high quality data acceptable to both the FDA and EMA,’ she said.
‘The speed of both ethical approval and TGA notification are also acknowledged as being in Australia’s favour as is the impact of sites with dedicated clinical trial offices that play a key role in patient recruitment,’ says Soulis.
Including the up to 43.5% refundable tax offset for eligible R&D activities makes Australia a very attractive location for clinical trials.
However, despite these clear benefits, countries in the region such as China and India have considerable population advantages that cannot be matched by Australia.
While this is potentially a shortcoming, the creation of clinical trials networks means that almost the entire country’s population, including those in regional and rural areas can be recruited for clinical studies.
‘Networks bring together hundreds of doctors, nurses, allied health and research professionals,’ said Professor John Zalcberg, Chairman of the Board of Directors of the Australian Clinical Trials Alliance. ‘Networks build first-rate expertise in the design and conduct of trials, create research efficiencies and ensure that the benefits of clinical research are distributed widely across the health system,’ he said.
The horizontal distribution across the system promoted by networks ensures that trials are more likely to be broadly representative of current world practice. They provide training and mentoring for the clinical trials workforce outside the major metropolitan teaching hospitals, and maximise access to new treatments for eligible patients.
There are more than 50 clinical trials networks in Australia who collectively have completed or initiated more than 1,000 clinical studies involving more than 1 million participants and representing at least $1 billion in total research funding since 2004.
‘While there is an emphasis on oncology trials, almost 10% of Australian trials networks focus on neurological diseases,’ says General Manager Soulis. ‘This is important because most trials in neuroscience require sophisticated imaging technologies – MRI, CT and PET scanning – as well as bio-marker identification and quantitation, usually through bio-banking. Without networks that allow us to access these technologies, information derived from each trial would be limited and the anticipated improvements in healthcare delayed,’ she said.