Australia is making a concerted effort to bring in more clinical trials, citing advantages such as low costs, fast turnover, a multicultural population and a generally favourable business climate.
According to the inward investment agency Invest Australia, the country is rapidly gaining recognition in the pharmaceutical and biotechnology industries as an attractive location for trials. It backed this up with testimonies from multinationals such as GlaxoSmithKline, which invests more than A$30 million (US$24.8 million) per year on research and development in Australia.
The agency also cited a benchmarking study by the Economist Intelligence Unit (EIU), which looked at operating factors specific to the pharmaceutical industry in Australia, India, Germany, Japan, Singapore, the UK and the US. Australia ranked third overall in this respect but first in terms of its clinical trial capabilities.
Plus points included relatively low average costs compared with other established markets for clinical studies, a generous number of trial sites and a high percentage of trials completed on schedule. Australia fared less well on the number of clinical trials actually taking place during the study period, although this “indicates substantial capacity to invest further in clinical trials”, the EIU commented.
At the moment, some 700 clinical trials are conducted at more than 2,000 sites around Australia each year. A survey for the EIU report, which covered the period 1 January 2003 to 1 January 2004 (the study was published in September 2005), recorded 622 clinical trials at 2,135 sites in Australia for the year, more than Japan (550 trials), India (200) and Singapore (195) but well below the 1,300 studies conducted in Germany, 6,174 in the UK and 39,731 in the US. Even on a per capita basis Australia ranked fourth among these countries, above India, Japan and Germany but behind Singapore, the UK and the US.
Given this lag, and the fast-emerging competitive threat from low-cost clinical trial locations such as India, Central and Eastern Europe and Latin America, it is not surprising that Australia is now setting out its stall. Among the selling points highlighted by Invest Australia is the country’s multicultural make-up, which positions it well for studies in defined ethnic groups. Some 200 different countries feed into the Australian melting pot, offering “a microcosm of the world’s populations”, the agency notes.
Another pragmatic advantage is Australia’s reverse seasonality with the Northern Hemisphere, which provides pharmaceutical companies from countries like the UK with new opportunities to test drugs or vaccines for seasonal conditions such as influenza, asthma and hayfever.
Add to this a high-quality health infrastructure, with a ready supply of nurses and clinicians trained in research procedures, a strong research base and a burgeoning biotechnology industry. According to Daniel Tassé, managing director of GlaxoSmithKline Australia, there is “no doubt that Australia’s health and medical research are world standard. Australian researchers possess significant understanding and expertise in many of the expanding areas of medical science, particularly gene- and protein-related research”.
Professor Graham Macdonald, external licensing co-ordinator for Merck Sharp & Dohme in Australia, says the country’s biotechnology industry offers “exceptional scientific talent, high-quality R&D, strong intellectual property laws and excellent research facilities, which makes it very attractive to overseas investors”.
For all these benefits, cost and speed are inevitably key drivers in the siting of international clinical trials. On the cost front, Australia compared quite favourably with other established markets in the EIU survey. Average clinical trial costs per patient in 2003 were estimated at US$3,984 in Australia, versus US$2,500 in India, US$4,400 in Singapore, US$5,000 in Germany, US$6,000 in the UK, US$6,716 in the US and US$18,000 in Japan. Again on a per patient basis, Australia was the second cheapest market behind India for all stages of clinical development, including Phase IV studies.
Australia also scored well on its turnover of trials, with 80% completed within the allocated time – behind India (85%) and on a par with Singapore, but well ahead of the UK (65%), Germany (30%), Japan (30%) and the US (10%).
For all that, there was room for improvement in approval times, with ethics committee approval in Australia during the period January 2003 to January 2004 taking an average of 11-16 weeks – only slightly faster than India (12-15 weeks) but conspicuously slower than the UK (6-9), Germany (5-10), Japan (4-6), Singapore (4-6) and the US (1-4).