This blog will explore the role/ definition and introduction of the CTN and CTX schemes and how these schemes are shaping the clinical trials sector in Australia
With clinical trials activity growing globally the pressure is on clinical trials providers to streamline their services. Clinical trials are a growth sector worldwide driven by our desire to improve healthcare as well as fostering R&D in the life sciences. Locally, with a compound annual growth rate of 5% for clinical trials started between 2010 and 2015 this sector is one of the fastest growing in Australia. Along with the Netherlands and China we outperformed high activity countries such as Germany and the USA that have much lower rates of growth.
‘In those countries there is no pressure to modify infrastructure because the growth is just not there,’ says Dr Tina Soulis, General Manager of Neuroscience Trials Australia. ‘Here, we are faced with a double whammy of increased trials activity generally and a predicted escalation in neurological studies specifically, in the next decade. Anything that reduces the complexity of clinical trials so that we can better cope with the increased demand is most welcome,’ said Soulis.
A recent key feature that has helped smooth the clinical trials path is the introduction by the TGA of electronic lodgement of CTN and CTX schemes. CTN, or clinical trial notification involves submission to the TGA of institutional HREC and governance approval and trial documentation. This information is recorded but not reviewed by the TGA. In contrast, clinical trial exemption (CTX) documents are reviewed by TGA representatives as a first step following which any number of clinical trials may be conducted without further assessment by the TGA.
‘While most of our trials are conducted under the CTN scheme the elimination of paper-based application to either scheme is a saving for us in terms of time and resources that will help us manage the increase in trials demand over the next five years,’ says Soulis.
The benefits of electronic data capture are not lost on the TGA, either. According to Adelina Tan, Director, Experimental Products at the TGA, paper-based submissions are quite burdensome administratively and prone to error leaving the clinical trial statistics for the period 2009-2012 as ‘inaccurate’. Electronic submission means improved document tracking, legibility of entries, and instantaneous access to application status.
Perhaps best of all, clinical trial activities and trends can be identified in a manner that could champion Australia as a better choice for the conduct of clinical trials. Tina Soulis sees these improvements as a win-win, ‘the lodgement process is simpler, we know that our application has been received, and reports are accurate and more detailed. It streamlines our process so that we can manage the increased demand for our services.’