$14m in inefficiencies
April 1, 2014
fURTHER to Medicines Australia
(MA) ceo Dr Brendan Shaw’s call
to action on regulatory reform for
clinical health trials (PD 31 Mar),
Shaw has said while implementing
national reforms could be complex
and time consuming, the pace
could be enhanced, and this was
something the incoming Abbott
Government had recognised in its
pre-election commitment.
Regulatory inefficiencies, which
Shaw said made it harder to attract
investment in pharmaceutical
R&D to Australia, included that
companies had about a one in
three chance of getting their
ethics and governance compliance
applications approved within 60
days of submitting them.
“In around 30% of cases, it takes
more than six months to initiate a
clinical trial in Australia.
“We estimate that inefficiencies
in the area of research governance
alone cost the industry around $14
million each year.
This was money that could be
used for research instead of on
unnecessary paperwork, he said.
Eleven proposed reforms were
made by the Clinical Trials Action
Group including a nationally
harmonised system of ethics review
for multi-centre clinical trials.
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