Greg Hunt revives one-stop-shop idea for Aussie clinical trials

Health Minister Greg Hunt has revived a long-standing plan to turn Australia into a “one stop shop” for clinical trials, saying he will ask the National Cabinet to prioritise reforms around ethical approval processes.

Industry groups are publicly backing the call, which could enhance an industry that was worth $1bn in 2015, according to the latest data available, as the local industry rapidly gears back up to normal levels.

Government plans to streamline clinical trials processes in Australia go back more than two years. Hunt promised a review of the clinical trial registry system in 2018, but the report delivered that year is still “being considered” by the government, and $7m was allocated in 2017 for states and territories to redesign their trial processes.

“What we have now is a high degree of international interest, building on what was already a high degree of interest for clinical trials and for research in Australia,” Hunt said last week during an address to the Centre of Economic Development of Australia (CEDA).

“Many of the systems in other countries for non-COVID research have had to be put on deep pause and as a consequence of that, we know already that there’s an interest in rapid movement for phase 1, phase 2 and parts of phase 3 trials to Australia.

“We are now moving with the states and territories to set up a one-stop-shop for ethics approval.

“If there’s a standard and institutions are included, then that will expedite that investment process.”

It’s already not terrible

Australia already has a well streamlined ethics system.

Bob Proulx, chief of cancer imaging tech company Imagion Biosystems (ASX:IBX), told Stockhead last week the company was now looking to run phase 1/2 trials in Australia because institutions used the same human ethics approval systems, unlike in the US where different institutions, let alone states, had different processes and requirements for everything from ethics to how a trial was conducted.

“Australia has done a good job of streamlining that process and making it both affordable and, for a small company like us, more timely,” he said.

Industry wish list

However, Medicines Australia says areas that can be improved are around the R&D tax incentive, and more generally, harmonisation of the arrangements surrounding clinical trials nationwide.

“This is an opportunity for the commitments to a harmonised regulatory streamlined process for clinical trials to be front and centre. We want to minimise the barriers to conducting clinical trials and this is an ideal opportunity to look at those,” Medicines Australia chief Elizabeth de Somer told Stockhead in April.

Medical Technology Association of Australia (MTAA) wants a single ethical review for all studies, whether conducted in a private or public setting, and an Australian Coordinating Body for Clinical Trials to lobby for changes that could make Australia more competitive as a clinical trial location.