Clinical trial reforms need urgent boost

In a speech to the Australian Clinical Trials Alliance today, Medicines Australia Chief Executive, Dr Brendan Shaw, called on the Government to work with the industry to implement its election promise to accelerate clinical trial regulatory reform.

“Despite a recent increase in clinical trial activity in Australia, our share of the global investment in this area continues to decline,” Dr Shaw said.

“We know what the problems are: high costs, regulatory inefficiencies, low patient recruitment rates and a public health system where research is an extra-curricular activity.

“The solution is to implement reforms identified over three years ago and do this within the next 12 months.

“Last year, the McKeon Review of Health and Medical Research called for clinical trial reform to be made an ‘urgent national priority’. Medicines Australia shares this view.”

The Australian Government made a commitment during last year’s election campaign to accelerate the pace of clinical trial regulatory reform.

“We are delighted by this commitment and we look forward to working with the Government on its implementation,” Dr Shaw said.

“This is a great opportunity for Australia if we can move towards a more efficient and attractive environment for clinical trials in Australia.

“Clinical trials are important not only for the massive investment they bring to Australia, but also for the role they play in improving Australia’s healthcare system.

“Australia is recognised globally as having some of the best scientists and research infrastructure in the world. Despite this, Australia has not benefited from the dramatic shift in

global R&D spending in the pharmaceutical industry away from Europe and North America towards markets in the Asia-Pacific region.

“Australia faces fierce competition for clinical trial investment, and regulatory inefficiencies and extraordinarily high costs make it harder to attract that investment here.

“Together with government, we can make this country a leading destination for global investment in clinical trials for years to come.”

A copy of Dr Shaw’s speech is available here (please follow link)


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