Australia has an enviable reputation for clinical trials, especially in the Asia-Pacific region. World-class medical practitioners backed by an internationally recognised basic science community make Australia the location of choice for clinical trials, especially in the growing field of studies in neuroscience.
‘We also have the infrastructure that simplifies the passage of trials through the ethical and regulatory pathway,’ says Dr Tina Soulis, General Manager of Neuroscience Trials Australia. ‘A key component of this process is the TGA clinical trial notification scheme,’ she says.
Under the CTN scheme the TGA is not required to review any primary data relating to a clinical trial; it remains as a notification repository. Rather, institutional HRECs, in addition to assessing the ethical acceptability of a proposed trial, are responsible for assessing the scientific validity of trial design and the safety and efficacy of the medicine under investigation.
‘Factors affecting speed of delivery are critically important for us at this time,’ says Soulis. ‘Our share of international clinical trials in neuroscience is expected to rise by 24% over the next three years so anything that helps us meet this demand without affecting the quality of our service is paramount.’
Dr Soulis predicts that the increase in neuroscience trials will predominantly focus on Phase I studies. ‘Australia tends to have a stronger position generally in trials in rapidly changing disease areas or trials with a complex design. These trials require high quality data and treatment environments, and high levels of involvement by key opinion leaders, especially in the early stages. We have a particularly high international reputation in neurological diseases of older age such as Alzheimer’s disease, that makes Australia the country of choice in the region for early phase studies,’ she said.
That is not to say there will not be similar growth in later phase neuroscience trials. Phase II and Phase III trials as a whole are predicted to grow by 7% and 14% respectively over the same period. ‘There is no reason to think that growth in neuroscience trials will be any less than this,’ says Soulis, ‘after all, those factors promoting Australia as a desired location for Phase I studies will have the same impact on later phase studies, increasing their numbers here as a result,’ she said.