The details are contained in two recent publications on clinical trials activity. The June 2017 MTPConnect report titled ‘The Economic Profile and Competitive Advantage of the Sector’ is data rich and was developed with extensive input from the industry and Government. The document provides a status update and suggestions on how to further stimulate the sector. In January, Austrade issued a Clinical Trials Capability Report ‘A Dynamic Environment for Clinical Trials’, essentially a pitch to clients requiring clinical research of therapeutic products and medical devices. It highlights the range of expertise available in Australia, from cell culture and engineering to Independent Ethics Committees, by showcasing local companies and providing a directory of suppliers.
This becomes important when put in the context that approximately 75% of the direct expenditure on clinical trials in 2015 in Australia came from international inbound investment by commercial entities (pharmaceutical, biotechnology and medical device companies). Another statistic included in the Austrade report that requires consideration is that ‘medicines and vaccines are Australia’s largest manufactured export. China and the United States are the biggest markets, followed by New Zealand, South Korea and the United Kingdom.’
As Figure 1 demonstrates, multiple factors contribute to clinical trial placement. When considering the shift over time in the type of clinical trials being conducted in Australia, the influence of a number of these factors is obvious. Previously, Phase III studies were the largest component of activity, however Phase I trials numbers have increased steadily, growing 17.2 % from 2012–2015, compared with 1.8 % globally over the same period. This is a reflection of the strong competitive position of Australia in conducting complex studies as a result of our world-class healthcare system, high quality medical research infrastructure, skilled workforce of scientists and healthcare professionals, including internationally regarded clinicians.
At the same time, the later phase, higher patient number studies have been increasingly placed in more populous locations in the Asia Pacific, Eastern Europe or Latin America, as the larger patient pools shorten recruitment times, and ultimately, the time to market of new products. Additionally, Australia’s population size and distribution mean that more investigational sites must be established to reach target recruitments when studies are placed in Australia, resulting in a higher per patient cost than other countries. Significant efforts have been undertaken on a number of fronts over the past decade to increase recruitment efficiencies. These include the streamlining of ethic approval processes via mutual recognition and increased public awareness. In 2015, of the 1,305 industry-sponsored studies in Australia, Phase III accounted for 40%; Phase II, 22%; Phase I, 18%; Phase IV, 4% and Other, the remaining 16%.