Clinical Trials & Services

Australia is fertile ground for clinical trials, with low costs, a streamlined regulatory regime and expertise in conducting the studies.

International drug makers have given Australia a vote of confidence. Bristol-Myers Squibb, for example, formally designated Australia as one of its 14 international hubs for clinical trials in 2003. This capped more than a decade of Bristol-Myers Squibb clinical trials in Australia, involving 200 investigators, 100 research centres, 10,000 patients and trials covering a range of diseases.

Cancer Trials Australia is the preferred provider of early-phase cancer clinical trials in the Asia Pacific and has been selected by Pfizer as one of its 10 preferred centres worldwide for early-phase testing of oncology drugs.

Innovative and resourceful

“Australians are inquisitive, innovative and resourceful people,” says Daniel Tassé, MD of Glaxo-SmithKline Australia. “The country’s high levels of basic science training make it a good environment for clinical trials and other research that form the backbone of the pharmaceutical industry.”

The overall cost of conducting clinical trials in Australia is comparable to eastern Europe. Investigator fees per patient in Australia, for example, are half those in the US and Canada. Regulatory processes are also swift and streamlined. Under the Clinical Trial Notification scheme, companies can start clinical trials within a week of receiving acknowledgement from the Therapeutic Goods Administration, the Australian drugs approval authority.

Clinical trial services

Australia’s expertise can also support trials in other countries. Quintiles Japan, for example, uses Japanese-speaking medical data managers in Adelaide, South Australia, to complement its team in Japan.

“Pharmaceutical companies require cost-effective solutions to address their development programs without comprising on quality and standards,” says Derek Winstanly, Chairman of Quintiles Transnational Japan KK. “Our Adelaide centre of excellence meets these requirements. With highly skilled and multilingual staff, Australia is a compelling case for companies to offshore their data management, bio-statistics and medical report writing work.”

With competitive hiring costs and a wealth of multilingual science graduates, Australia was a natural choice. Quintiles had operated a thriving data services business in the country since 1995, mainly serving Australasia and South-East Asian markets.

“The ease with which we could recruit highly educated people was the main reason we chose to develop Japanese data services in Australia,” says Cliona O’Donovan, Director, Data Services at Quintiles Australia. “We can hire skilled science graduates who also have a background in languages.”

O’Donovan’s team has managed multilingual studies involving 6000 patients enrolled at 190 sites. Recent services provided to a major Japanese sponsor, for example, involved 700 Japanese patients from 41 sites in Japan, Brazil and Peru.

>> www.investaustralia.gov.au/biotech