August 7, 2014

The future of clinical trials in Australia

Clinical trials provide access to new treatments, contribute to Australia’s economy and support our public sector institutions. Dr Brendan Shaw, Medicines Australia Chief Executive, discusses the challenges and opportunities that are shaping our innovative medicines industry.

Growth opportunities for clinical trials in Australia exist. Medicines Australia’s Chief Executive discusses these opportunities and the key role of the innovative medicines industry.

As Medicines Australia Chief Executive Dr Brendan Shaw points out, the innovative medicines industry plays a key role in medical research in Australia.

“The industry invests over $1 billion annually in research and development (R&D), which makes it one of the most important R&D industries in Australia,” he says. “A significant portion of the industry’s contribution to medical research is in the area of clinical trials – 65 percent of Australia’s clinical trials are funded by the private sector.”

As well as contributing to Australia’s economic and innovation base, clinical trials importantly provide Australian patients with an opportunity to access new treatments that aren’t yet available on the market.

“They also build capability in, and links with, Australia’s public sector institutions,” Dr Shaw continues. “55 percent of industry-funded clinical trials are conducted through public hospitals, with a further 25 percent conducted through universities and research institutes.”

A changing focus

The world’s fastest-growing locations for international clinical trial activity are countries such as India and China, which have large populations and rapidly-improving research infrastructures.

“These countries have a strong and sustainable competitive advantage in hosting late-stage clinical trials, which require large numbers of patients to be involved in individual research projects,” says Dr Shaw. “However, Australia can maintain its capacity to conduct certain types of clinical trials, especially early-stage clinical trials which require far fewer individuals to be involved, and whose success largely depends on the experience and accomplishments of individual researchers.”

The latest statistics from the Therapeutic Goods Administration suggest this shift is already underway.  In 2013, while the overall number of clinical trials commenced in Australia fell by 10 percent compared with the previous year, the number of early-stage Phase 1 clinical trials increased by over 40 percent.

“Australia has real potential to grow in this area given our excellent research capabilities, good reputation and high international standing,” says Dr Shaw. “But, while the increase in Phase 1 trials is encouraging, we know that Australia hasn’t benefited from the massive shift in clinical trial investment away from traditional centres like North America and Western Europe to the Asia-Pacific. Clinical trial investment in regional centres like Singapore, South Korea and Japan has increased by as much 300 percent since 2007 while Australia has struggled to even maintain existing levels of investment.”

Commitment to change

Last year, the McKeon Review of Health and Medical Research called for clinical trial reform to be made an ‘urgent national priority’ and the new figures demonstrate that reforms to improve the regulation of clinical trials and to reduce red tape are more important than ever.

In May this year, the federal government committed $10 million to progress key reforms. This came on top of an agreement by the Council of Australian Governments’ Standing Council on Health, which brings together all federal, state and territory health ministers, to identify and implement practical measures to enhance clinical trial activity in Australia.

“Medicines Australia welcomes both announcements and hopes they lead to real and urgent action,” says Dr Shaw. “We look forward to working in partnership with Australian governments, including state and territory governments, to ensure that Australia remains a leading destination for global clinical trial investment.”

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