Trial reforms ‘urgent’
March 31, 2014
Medicines Australia has said
regulatory reforms for clinical trials
is an “urgent national priority.”
Ceo Dr Brendan Shaw told the
Australian Clinical Trials Alliance
that the country’s share of global
investment in clinical trial activity
was decreasing, despite the
“massive” investment they brought
to Australia.
The country had not benefited
from the shift in global R&D
spending in the pharmaceutical
industry towards markets in the
region, he said, and regulatory
inefficiencies and high costs made
it harder to attract investment.
Low patient recruitment and
the public health system, which
did not focus on research, also
added to the decline in clinical trial
investment in the country, he said.
“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.”
MA welcomed the Government’s
promise last year to accelerate the
pace of regulatory reform, he said.
A National Health and Medical
Research Council (NHMRC)
spokesperson said with the
Department of Industry, it was
working to improve the clinical
trials environment in Australia and
to implement proposed reforms.
Specifically NHMRC was working
on a nationally consistent
approach, including working to
speed up the start of trials by
improving governance mechanisms.
The spokesperson said there
had been several reports which
indicated significant international
investment in Australian clinical
trials, such as MA’s report that in
2008 biopharmaceutical companies
funded more than 70% of ongoing
clinical trials in Australia.
“It is through the research
done in clinical trials that people
gain access to better treatments
sooner.”
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