How to save Australia’s declining clinical trials

Medicines Australia chief executive Dr Brendan Shaw today set out four key policy priorities to arrest the decline in the number of clinical trials conducted in Australia.

The priorities, outlined at Research Australia’s pre-NSW election Policy Forum are:

  • Release and implementation of the joint industry-Federal Government Clinical Trials Action Group’s recommendations to simplify and streamline the regulatory process for setting up clinical trials.
  • Implementation of the R&D tax credit, currently before the Federal Parliament, which would reduce by up to 10 per cent the cost of eligible R&D.
  • Rejection of the private members Bill in the Federal Parliament that proposes a ban on patents for biological materials, which would render industry funding of clinical trials untenable.
  • Reversal of the NSW Government’s decision to double – from $10 million to $20 million – the minimum insurance cover for clinical trials in NSW.

Dr Shaw told the forum that the number of clinical trials conducted in Australia had declined for the past three years.

“Fundamentally, Australia has a fantastic capability in clinical trials that we can build on to develop and grow the nation’s medical research,” Dr Shaw said.

“However, there are a number of policy changes that need to occur to help ensure we stop the decline and retain industry-funded clinical trials in the future.

“We need to harmonise the ethics approval process for clinical trials. There are currently 200 sites in Australia where companies can get approval for clinical trials, each operating its own system. In the 21st century this is simply madness. The problem should have been fixed long ago.

“Australia has a terrific base to do clinical trials. It has great science, a highly skilled workforce, relatively innovative research infrastructure and a long tradition of excellence in medical research.

“We need to get the financial and regulatory settings right to ensure we can maintain and build on this base to the benefit of all Australians.”

There were 680 individual clinical trial notifications in Australia in 2009. Every year more than 18,000 Australians participate in clinical trials, providing them with early access to potentially life-saving treatments.


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